FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 5 ]
36
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the vascular effects of two commonly used diabetes medications, rosiglitazone and glyburide in type 2 diabetic patients.
Rosiglitazone and glyburide are two commonly used diabetic medications that have both been shown to be effective in controlling blood glucose levels. Since they work in different ways, they may have different effects on the health of the blood vessels. This study will assess which medication is better at improving the ...
Type 2 Diabetes Mellitus
thiazolidinedione sulfonylurea endothelial function
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: rosiglitazone intervention 2: glyburide
1
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
36
0
0
0
NCT00123643
1COMPLETED
2005-12-01
2003-05-01
St. Paul Heart Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
40
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine: * effect size estimates for smoking cessation and post-cessation weight gain, which will be used to com...
Smoking Nicotine Dependence
Tobacco Smoking Weight Weight perception Naltrexone Bupropion
null
2
arm 1: The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day). arm 2: The active com...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment. intervention 2: Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for ...
intervention 1: Naltrexone intervention 2: Bupropion
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
40
0
0
0
NCT00129246
1COMPLETED
2005-12-01
2004-12-01
Yale University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
99
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy...
Acute Otitis Media Otitis Media Ear Infection
Ear Infections Otitis Media
null
2
arm 1: Treatment with montelukast for 4 months (4 mg per day) arm 2: Treatment with placebo for 4 months
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Montelukast intervention 2: Placebo
2
Bellevue | Pennsylvania | United States | -80.05172 | 40.49396 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
99
0
0
0
NCT00189462
1COMPLETED
2005-12-01
2004-03-01
Deborah Gentile
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
136
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study is to compare the overnight efficacy and plasma concentration-time profiles of armodafinil and PROVIGIL, after multiple doses, in patients with excessive sleepiness associated with chronic Shift Work Sleep Disorder (SWSD).
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL in Patients with Chronic Shift Work Sleep Disorder
Chronic Shift Work Sleep Disorder
null
5
arm 1: PROVIGIL 200 mg/day arm 2: Armodafinil 250 mg/day arm 3: Armodafinil 200 mg/day arm 4: Armodafinil 150 mg/day arm 5: Placebo
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: PROVIGIL 200 mg/day intervention 2: Armodafinil 250 mg/day intervention 3: Armodafinil 200 mg/day intervention 4: Armodafinil 150 mg/day intervention 5: Matching placebo tablets
intervention 1: PROVIGIL 200 mg intervention 2: Armodafinil 250 mg intervention 3: Armodafinil 200 mg intervention 4: Armodafinil 150 mg intervention 5: Placebo
20
Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 San Diego | Cali...
134
0
0
0
NCT00236080
1COMPLETED
2005-12-01
2005-08-01
Cephalon
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
224
RANDOMIZED
PARALLEL
9OTHER
0NONE
false
0ALL
null
To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed ...
Anemia
Anemia Cancer Chemotherapy
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: iron sucrose injection USP intervention 2: stable erythropoietin therapy
0
null
224
0
0
0
NCT00236951
1COMPLETED
2005-12-01
2003-02-01
American Regent, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
151
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
1FEMALE
null
Purpose of the study is the comparative evaluation of the clinical efficacy and of the general tolerability of two different subcutaneous FSH preparations (Fostimon® IBSA Vs Gonal-F® Serono) when administered in patients undergoing ICSI
This is a multicentric, prospective, randomised, investigator blind, controlled clinical trial (phase III) of two parallel groups, one receiving the test drug FSH (Fostimon® , IBSA) and the other the reference drug FSH (Gonal-F®, Serono). The groups will be paired on the major prognostic criteria. In effect, a double ...
Infertility
Ovarian stimulation Infertility ICSI FSH
null
2
arm 1: Fostimon is an highly purified FSH preparation. arm 2: Gonal-F is a recombinant FSH preparation.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: subcutaneous injection of FSH. Starting dose: 225 IU. intervention 2: subcutaneous injection of FSH. Starting dose: 225 IU.
intervention 1: Follicle Stimulating Hormone intervention 2: Follicle Stimulating Hormone
7
Bron | N/A | France | 4.91303 | 45.73865 Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Marseille | N/A | France | 5.38107 | 43.29695 Neuilly-sur-Seine | N/A | France | 2.26965 | 48.8846 Paris | N/A | France | 2.3488 | 48.85341 Budapest | N/A | Hungary | 19.04045 | 47.49835
145
0
0
0
NCT00335725
1COMPLETED
2005-12-01
2003-03-01
IBSA Institut Biochimique SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
37
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This 6-month open label study will evaluate the long term safety of bosentan (via oxygen saturation) and efficacy (exercise capacity) in patients who have completed the BREATHE-5 study (PAH related to Eisenmenger physiology). Treatment duration is 6 months.
This is a multicenter, open-label, single -arm study with bosentan, initial dose of 62.5 mg b.i.d., with a target dose of 125 mg b.i.d. All patients will be assessed for eligibility during the baseline visit (same as Week 16, end of study BREATHE-5 visit), and will have the option to enter into the open-label extension...
Pulmonary Arterial Hypertension
bosentan PAH related to Eisenmenger physiology Tracleer
null
1
arm 1: The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
[ 0 ]
1
[ 0 ]
intervention 1: Patients will receive up to 125 mg b.i.d. of Tracleer.
intervention 1: Tracleer®
17
Boston | Massachusetts | United States | -71.05977 | 42.35843 Houston | Texas | United States | -95.36327 | 29.76328 Camperdown | N/A | Australia | 151.17642 | -33.88965 Victoria | N/A | Australia | N/A | N/A Vienna | N/A | Austria | 16.37208 | 48.20849 Leuven | N/A | Belgium | 4.70093 | 50.87959 Calgary | Alberta | Ca...
37
0
0
0
NCT00367770
1COMPLETED
2005-12-01
2004-01-01
Actelion
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
114
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a randomized, double-blind, multicenter clinical phase III study involving about 105 cancer patients aged \>18 years who are receiving palliative chemotherapy and who are suffering from chemotherapy associated anemia. A standard treatment group (ERYPO®) will be included to provide a reference reflecting current...
Eligible patients were randomized to one of two different treatment groups (EPO HEXAL or ERYPO) in a 2:1 ratio. Patients received double-blind treatment for a period of 12 weeks. Following randomization the patients were treated subcutaneously with a dose of 150 IU/kg body weight of study drug three times per week. Dos...
Anemia
Chemotherapy associated anemia in cancer patients
null
2
arm 1: HX575 (erythropoietin alfa of the Sponsor Hexal AG). Eligible patients to be randomized in ratio 2:1 and to be subcutaneously treated (solution for injection (s.c.)) for 12 weeks with HX575 in pre-filled syringes. The maximum weekly dose of HX575 was 300 IU/kg body weight to maintain hemoglobin levels in the the...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 1000, 2000, 4000, 8000 and 10.000 IU of rh erythropoiethin intervention 2: 1000, 2000, 4000, 8000 and 10.000 IU of epoetin alfa
intervention 1: HX575, solution for injection (s.c.) intervention 2: ERYPO®, Janssen-Cilag, solution for injection (s.c.)
19
Augsburg | N/A | Germany | 10.89851 | 48.37154 Bad Soden | N/A | Germany | 9.36404 | 50.28857 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Luckenwalde | N/A | Germany | 13.1...
114
0
0
0
NCT00711958
1COMPLETED
2005-12-01
2004-11-01
Sandoz
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
22
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
0NONE
true
0ALL
false
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions.
The purpose of this study is to evaluate and compare the relative bioavailability of Quinine Sulfate capsules following a single, oral dose in healthy volunteers under fasting and fed conditions. Twenty-two healthy, non-smoking, non-obese, male and female volunteers between the ages of 18 and 45 years of age will be r...
Healthy
Bioavailability
null
2
arm 1: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. arm 2: A single dose of Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Quinine Sulfate (2 x 324 mg capsules) administered after an overnight fast of at least 10 hours. intervention 2: Quinine Sulfate (2 x 324 mg capsules) administered 30 minutes after a standardized, high fat breakfast.
intervention 1: Quinine Sulfate 2 x 324 mg Capsules intervention 2: Quinine Sulfate 2 x 324 mg Capsules
0
null
44
0
0
0
NCT00726414
1COMPLETED
2005-12-01
2005-12-01
Mutual Pharmaceutical Company, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
351
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.
null
Perennial Allergic Rhinitis
null
4
arm 1: Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray arm 2: Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray arm 3: Mometasone furoate nasal spray 200 μg/day(QD) arm 4: Fluticasone Propionate...
[ 2, 2, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks intervention 2: Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take...
intervention 1: Placebo for MF intervention 2: Placebo for FP intervention 3: Mometasone intervention 4: Fluticasone
0
null
351
0
0
0
NCT00783224
1COMPLETED
2005-12-01
2005-09-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
31
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This was a prospective, open, non-comparative study to evaluate the safety and efficacy of recombinant human luteinizing hormone (rhLH, Luveris) administered subcutaneously (s.c.) in follicular development during ovulation induction in 31 Chinese female subjects with hypogonadotropic hypogonadism.
The objective of this prospective, open, non-comparative study was to assess the safety and efficacy of rhLH (Luveris) administered subcutaneously in follicular development during ovulation induction in Chinese female subjects with hypogonadotropic hypogonadism. The study was organized on an outpatient basis involving ...
Hypogonadism
Hypogonadism Recombinant human follicle stimulating hormone (r-hFSH) Recombinant leutinizing hormone (r-hLH)
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: One r-hLH (75 International Units \[IU\]) injection s.c. once daily. intervention 2: One r-hFSH (150 IU) injection s.c. once daily. intervention 3: After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.
intervention 1: Recombinant human luteinizing hormone (r-hLH) intervention 2: Recombinant human follicle-stimulating hormone (r-hFSH) intervention 3: Human chorionic gonadotropin (hCG)
1
Beijing | N/A | China | 116.39723 | 39.9075
31
0
0
0
NCT01084265
1COMPLETED
2005-12-01
2004-02-01
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
337
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study was to assess the efficacy of Sativex in relieving symptoms of spasticity in multiple sclerosis
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with symptoms of spasticity due to multiple sclerosis. Eligible subjects entered a seven day baseline period. Subjec...
Multiple Sclerosis
null
2
arm 1: Active treatment arm 2: Control
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours. intervent...
intervention 1: Sativex intervention 2: Placebo
1
Reading | N/A | United Kingdom | -0.97113 | 51.45625
337
0
0
0
NCT01599234
1COMPLETED
2005-12-01
2005-03-01
Jazz Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
267
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
null
Pulmonary Hypertension
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Sildenafil citrate
52
La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Torrance | California | United States | -118.34063 | 33.83585 Torr...
265
4
0.015094
1
NCT00159861
1COMPLETED
2006-01-01
2003-07-01
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4INDUSTRY
false
false
false
null
0
2
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.005885
[ 3 ]
195
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to determine whether Xyrem (sodium oxybate) is effective when used alone to treat the pain and sleep disturbances of fibromyalgia.
Fibromyalgia affects millions of Americans, yet there are no FDA approved drugs to treat this debilitating condition. Besides causing pain, it also disrupts normal sleep patterns in many of its victims. Pain and lack of sleep reinforce each other, making patients progressively more miserable. Xyrem is a potent hypnotic...
Fibromyalgia
Fibromyalgia Pain
null
3
arm 1: Sodium oxybate 6.0 g per day. arm 2: Placebo (one of two doses matching active treatment by volume). arm 3: Sodium oxybate 4.5 g per day.
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Xyrem (sodium oxybate) oral solution 4.5 g per day in divided doses, 2.25 g at bedtime and another 2.5 g two and a half to four hours later for 8 weeks. intervention 2: Xyrem (sodium oxybate) oral solution 6.0 g per night in divided doses of 3 g at bedtime and 3 g at 2.5 to 4 hours later for 8 weeks. in...
intervention 1: Xyrem (sodium oxybate) oral solution intervention 2: Xyrem (sodium oxybate) oral solution intervention 3: Placebo
20
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Beverly Hills | California | United States | -118.40036 | 34.07362 Los Angeles | California | United States | -118.24368 | 34.05223 Miami | Florida | United States | -80.19366 | 25.77427 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Lexingt...
192
0
0
0
NCT00087555
1COMPLETED
2006-01-01
2004-07-01
Jazz Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
685
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the clinical and microbial efficacy and safety of AzaSite compared to vehicle for bacterial conjunctivitis. Adults and children one year of age and older with bacterial conjunctivitis in at least one eye may be eligible. Subjects will be randomly assigned to receive either 1.0 %...
null
Bacterial Conjunctivitis
Bacterial Conjunctivitis Pink Eye Conjunctivitis Eye Infection Eye Discharge
null
2
arm 1: None arm 2: None
[ 0, 3 ]
2
[ 0, 10 ]
intervention 1: 1.0% AzaSite contains 1.0% azithromycin, sodium hydroxide, mannitol, poloxamer 407, citric acid anhydrous, sodium citrate, DuraSite® (polycarbophil, sodium chloride, EDTA disodium and water for injection) and benzalkonium chloride 0.003%. AzaSite was prescribed as a single topical drop to the infected ...
intervention 1: AzaSite intervention 2: Vehicle
32
Flagstaff | Arizona | United States | -111.65127 | 35.19807 Cudahy | California | United States | -118.18535 | 33.96057 Petaluma and Santa Rosa | California | United States | N/A | N/A San Diego | California | United States | -117.16472 | 32.71571 Wheat Ridge | Colorado | United States | -105.07721 | 39.7661 Waterbury ...
683
0
0
0
NCT00105534
1COMPLETED
2006-01-01
2004-07-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
122
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This drug is being developed to treat cardiac edema. The primary purpose of this study is to investigate the dose response for body weight in seven-day repeated oral administration of OPC-41061 at 15, 30, and 45 mg or placebo in patients with extracellular volume expansion secondary to CHF despite taking furosemide at ...
null
Heart Failure, Congestive Edema
OPC-41061 Tolvaptan Heart Failure Edema Extracellular volume expansion
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: OPC-41061(Tolvaptan)
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
118
0
0
0
NCT00234104
1COMPLETED
2006-01-01
2004-08-01
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
478
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is a double-blind, randomized, multicenter, parallel-group, equivalence study involving about 462 clinically stable hemodialysis patients aged 18 years or above suffering from anemia and treated previously with a stable dose of ERYPO® intravenously.
The primary objective of this Phase III study is the evaluation of therapeutic equivalence of HX575 Hexal AG and a comparator of epoetin alfa, ERYPO® in the maintenance intravenous treatment of renal anemia. Efficacy, dosage and safety of HX575 Hexal AG in the long-term treatment were assessed.
Anemia
Treatment of anemia in hemodialysis patients
null
2
arm 1: Eligible patients were switched from the comparator ERYPO®, to epoetin alfa HX575 Hexal AG in ratio 2:1 to be intravenously treated with HX575 in pre-filled syringes for 24 weeks (solution for injection i.v.). The maximum weekly dose was 300 UI/kg body weight (given 1 to 3 times) to maintain hemoglobin levels be...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: HX575 Solution for i.v. injection Containing 1000, 2000 and 4000 IU of rh erythropoietin intervention 2: Solution for i.v. injection
intervention 1: HX575 epoetin alfa Hexal AG intervention 2: ERYPO®, Janssen-Cilag
54
Feldkirch | N/A | Austria | 9.6 | 47.23306 Graz | N/A | Austria | 15.45 | 47.06667 Graz | N/A | Austria | 15.45 | 47.06667 Graz | N/A | Austria | 15.45 | 47.06667 Innsbruck | N/A | Austria | 11.39454 | 47.26266 Sankt Pölten | N/A | Austria | 15.63333 | 48.2 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Au...
478
0
0
0
NCT00666835
1COMPLETED
2006-01-01
2004-04-01
Sandoz
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
45
RANDOMIZED
PARALLEL
null
2DOUBLE
true
0ALL
false
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses).
This study is a multiple ascending dose study to Assess the Safety, Tolerability, and Pharmacokinetics of orally dosed PG 760564 Administered Twice Daily to Healthy Male and Female Volunteers for 14 Days (27 Doses). The study is a multiple rising dose (MRD) study of active drug vs. placebo.
Healthy
Pharmacokinetics
null
5
arm 1: placebo capsule arm 2: 50 mg PG 760564 active arm 3: 100 mg PG 760564 active arm 4: 200 mg PG 760564 active arm 5: 400 mg PG 760564 active
[ 2, 0, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: oral capsule, 2x/day for 14 days intervention 2: oral capsule, 50 mg, 2x/day for 14 days intervention 3: oral capsule, 100mg, 2x/day for 14 days intervention 4: oral capsule, 200 mg, 2x/day for 14 days intervention 5: oral capsule, 400 mg, 2x/day for 14 days
intervention 1: Placebo intervention 2: PG-760564 intervention 3: PG-760564 intervention 4: PG-760564 intervention 5: PG-760564
1
Miami | Florida | United States | -80.19366 | 25.77427
45
0
0
0
NCT00791388
1COMPLETED
2006-01-01
2005-08-01
Procter and Gamble
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
10
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
Half the group will be given a high fat diet and the other half will fast. They will then be crossed over.
A food-effect study which will be conducted at any time during the MRD study period on one single cohort of subjects using 200 mg oral dose of PG 760564. Half the group will be given a high fat diet and the other half will fast. They will ten be crossed over.
Healthy
pharmacokinetics study
null
2
arm 1: 200 mg PG 760564, Subjects Fasted, single dose arm 2: 200 mg PG 760564, Subjects Fed high fat meal
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 200 mg capsule, single dose,fasted when dosed, duration is 4 days intervention 2: 200 mg capsule, single dose,high fat diet when dosed, duration is 4 days
intervention 1: PG-760564 intervention 2: PG-760564
1
Miami | Florida | United States | -80.19366 | 25.77427
20
0
0
0
NCT00791817
1COMPLETED
2006-01-01
2005-08-01
Procter and Gamble
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
188
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
null
This 5-part study will evaluate the safety, tolerability, and pharmacokinetics of two formulations of MK-0517 (with and without polysorbate 80) and aprepitant in healthy adults. Parts I to IV of this study will examine different doses of MK-0517 as well as two different formulations of MK-0517 (with and without polysor...
null
Chemotherapy-Induced Nausea and Vomiting Postoperative Nausea and Vomiting
null
14
arm 1: 100 mg MK-0517 (nonpolysorbate 80 formulation \[non-PS80\]) or placebo → 150 mg MK-0517 (non- PS80) or placebo → 125 mg aprepitant arm 2: 100 mg MK-0517 (PS80 formulation \[PS80\]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant arm 3: 40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant arm ...
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
12
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: MK-0517 (PS80 formulation), 1 mg/mL, administered intravenous (IV) over 15 minutes intervention 2: MK-0517 (PS80 formulation), 1 mg/mL, administered IV over 15 minutes intervention 3: MK-0517 (Non-PS80 formulation), 1 mg/mL, administered IV over 15 minutes. Midazolam is co-administered as a single oral ...
intervention 1: 90 mg MK-0517 (PS80) intervention 2: 100 mg MK-0517 (PS80) intervention 3: 100 MK-0517 (PS80) + 2 mg midazolam intervention 4: 115 mg MK-0517 (PS80) intervention 5: 150 mg MK-0517 (PS80) intervention 6: 40 mg MK-0517 (non-PS80) intervention 7: 100 mg MK-0517 (non-PS80) intervention 8: 150 mg MK-0517 (No...
0
null
424
0
0
0
NCT00990821
1COMPLETED
2006-01-01
2005-01-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
11
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study will assess whether daclizumab impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 1 day, and the target sample size is 82 individuals.
null
Kidney Transplantation
null
2
arm 1: Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram \[mg/kg\]) with Day 1 vaccine administered immediately prior to the fifth dose. arm 2: Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.
[ 0, 1 ]
3
[ 2, 0, 2 ]
intervention 1: Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response. intervention 2...
intervention 1: DT intervention 2: Daclizumab intervention 3: KLH
5
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Kansas City | Missouri | United States | -94.57857 | 39.09973 Portland | Oregon | United States | -122.67621 | 45.52345
11
0
0
0
NCT02576145
1COMPLETED
2006-01-01
2003-04-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
152
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Study will assess efficacy, safety and tolerability of brivaracetam in post-herpetic neuralgia (PHN). Duration of 7 weeks divided into 3 periods with no up-titration, nor down-titration.
null
Neuralgia, Postherpetic
Post-herpetic Neuralgia (PHN) Brivaracetam
null
3
arm 1: Matching placebo tablets administered twice a day. arm 2: Brivaracetam 200 mg/day (100 mg administered twice a day). arm 3: Brivaracetam 400 mg/day (200 mg administered twice a day).
[ 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Daily oral dose of two equal intakes. intervention 2: Daily oral dose of two equal intakes.
intervention 1: Placebo intervention 2: Brivaracetam
50
Brussels | N/A | Belgium | 4.34878 | 50.85045 Eeklo | N/A | Belgium | 3.55654 | 51.18703 Genk | N/A | Belgium | 5.50082 | 50.965 Liège | N/A | Belgium | 5.56749 | 50.63373 Lubbeek (Pellenberg) | N/A | Belgium | 4.83896 | 50.88278 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Sofia | N/A | Bulgaria | 23.32415 | 42.69751...
152
0
0
0
NCT00160667
1COMPLETED
2006-01-05
2004-10-11
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
73
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
Eligible subjects will be randomized to receive VALTREX® tablet 1g or placebo once daily for 60 days in a two-way crossover study with a washout period of 7 days between treatment periods.
null
Infections, Herpesviridae
viral shedding Recurrent herpes genital herpes
null
2
arm 1: VALTREX 1 g once daily, Placebo arm 2: Placebo, VALTREX 1 g once daily
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Valtrex 1g once daily intervention 2: placebo
intervention 1: Valaciclovir intervention 2: Placebo
17
Carmichael | California | United States | -121.32828 | 38.61713 Davis | California | United States | -121.74052 | 38.54491 Riverside | California | United States | -117.39616 | 33.95335 Sacramento | California | United States | -121.4944 | 38.58157 Fort Wayne | Indiana | United States | -85.12886 | 41.1306 Indianapolis...
128
0
0
0
NCT00116844
1COMPLETED
2006-01-10
2005-03-29
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
946
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
To investigate efficacy and safety of 4 doses of esmirtazapine, compared to placebo, in the treatment of moderate to severe hot flushes (vasomotor symptoms) associated with the menopause. Co-primary efficacy endpoints are the frequency and severity of hot flushes after 4 and 12 weeks as compared to Baseline.
The most direct treatment of hot flushes may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors (SSRIs) and other simi...
Postmenopausal Symptoms Menopause Vasomotor Symptoms
null
5
arm 1: Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks. arm 2: Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 3: Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks. arm 4: Participants...
[ 2, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Four different doses (2.25, 4.5, 9.0, and 18 mg) encapsulated esmirtazapine tablets in Swedish Orange hard gelatin DB-B capsules for blinding purposes. Encapsulated tablets were administered orally once daily in the evening prior to sleep for 12 weeks. intervention 2: Encapsulated placebo tablets in Swe...
intervention 1: Esmirtazapine intervention 2: Placebo
0
null
945
0
0
0
NCT00535288
1COMPLETED
2006-01-15
2004-09-15
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
943
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
false
The most direct treatment of vasomotor symptions (hot flushes) may be by means of 5-HT2A receptor antagonist. Mirtazapine is a potent blocker of 5-HT2A receptors and was found to be effective in reducing the number and intensity of hot flushes in preliminary trials. Also several Selective Serotonin Reuptake Inhibitors ...
null
Menopause Vasomotor Symptoms
null
5
arm 1: Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks arm 2: Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 3: Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks arm 4: Participa...
[ 2, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: esmirtazapine intervention 2: Placebo
0
null
941
0
0
0
NCT00560833
1COMPLETED
2006-01-15
2004-10-15
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
166
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
null
Infertility
Assisted Reproductive Technology (ART) Infertility Ovarian stimulation
null
8
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: GONAL-f (follitropin alfa) will be administered subcutaneously based on ART treatment guidelines, which determined the optimal dose of r-hFSH based on subject baseline characteristics/predictors of ovarian response throughout stimulation cycle. intervention 2: When at least 1 follicle greater than or eq...
intervention 1: Gonal-f intervention 2: Recombinant human chorionic gonadotrophin (r-hCG)
1
Paris | N/A | France | 2.3488 | 48.85341
161
0
0
0
NCT00249834
1COMPLETED
2006-01-16
2004-09-22
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
223
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics...
null
Epilepsy, Partial
Epilepsy Pediatric Partial onset epilepsy Levetiracetam Keppra
null
4
arm 1: Subjects had previously participated in study N159 in which they had received Placebo (PBO). arm 2: Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV). arm 3: Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: * Pharmaceutical form: Oral tablets and oral solution * Route of administration: Oral use
intervention 1: Levetiracetam
0
null
223
2
0.008969
1
NCT00150709
1COMPLETED
2006-01-25
1998-01-26
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0.002463
[ 3 ]
104
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to exploratively investigate the clinical efficacy of rebamipide on dry mouth in patients with Sjögren's syndrome in comparison with placebo.
null
Xerostomia Sjogren's Syndrome
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Rebamipide
1
Tokyo | N/A | Japan | 139.69171 | 35.6895
104
0
0
0
NCT00233363
1COMPLETED
2006-01-27
2005-04-15
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
81
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma. Primary hypothesis * Children with severe as...
High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United States. For the most severe exacerbations, albuterol is provided continuously at high doses until improvement is observed....
Asthma
Asthma Levalbuterol Albuterol Children
null
2
arm 1: Nebulized levalbuterol 10mg/hr given continuously arm 2: Racemic albuterol 20mg/hr given continuously
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 20mg/hr continuous racemic albuterol intervention 2: 10mg/hr continuous nebulized levalbuterol
intervention 1: Racemic albuterol (R+S albuterol) intervention 2: Levalbuterol (R albuterol)
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
81
0
0
0
NCT00124176
1COMPLETED
2006-02-01
2004-04-01
Children's Hospital of Philadelphia
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
172
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis. Subjects will receive subcutaneous injections of either 50 or 100 mg Golimumab or placebo every two or four weeks or an infusion of infliximab at week 2...
Rheumatoid Arthritis
Rheumatoid Arthritis CNTO 148 Methotrexate Joint pain Arthritis
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Type=exact, unit=mg/ml, number= 50 to 100 , form=powder for solution for infusion, route=sub cutaneous. intervention 2: Type=exact, unit=mg/ml, number= 10, form=powder for solution for infusion, route=sub cutaneous intervention 3: Type=exact, unit=mg/ml, form=powder for solution for infusion, route=sub ...
intervention 1: Golimumab intervention 2: MTX intervention 3: Placebo intervention 4: Infliximab
0
null
171
0
0
0
NCT00207714
1COMPLETED
2006-02-01
2003-11-01
Centocor, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
124
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Lung wash with KL₄Surfactant of individual lung segments using a bronchoscope compared to usual care alone consisting primarily of assisted (mechanical) ventilation in patients with acute respiratory distress syndrome(ARDS).
This is a multinational, multicenter, two-part, Phase 2 study that will evaluate the tolerability, safety, and efficacy of KL₄Surfactant in adult ARDS patients when administered by sequential bronchoscopic lavage into each of the 19 bronchopulmonary segments of the lung and as a bolus instillation into each lung.
Acute Respiratory Distress Syndrome
null
7
arm 1: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours. arm 2: 3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours. arm 3: 2 50-mL ali...
[ 0, 0, 0, 0, 0, 0, 5 ]
7
[ 0, 10, 0, 0, 0, 0, 0 ]
intervention 1: 3 30 mL aliquots at concentrations of 5, 5, and 10 mg/mL intervention 2: Standard ARDS management and ICU care intervention 3: 3 30 mL aliquots at a concentration of 10 mg/mL each intervention 4: 2 50 mL aliquots at concentrations of 10 and 20 mg/mL intervention 5: 2 50 mL aliquots at concentrations of ...
intervention 1: A.1 Lucinactant intervention 2: B.3 SoC intervention 3: A.2 Lucinactant intervention 4: A.3 Lucinactant intervention 5: A.4 Lucinactant intervention 6: B.1 Lucinactant intervention 7: B.2 Lucinactant
1
Warrington | Pennsylvania | United States | -75.13406 | 40.24927
124
0
0
0
NCT00215553
6TERMINATED
2006-02-01
2001-05-01
Windtree Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
39
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a ...
null
Rhinitis, Allergic, Seasonal
null
6
arm 1: Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. arm 2: Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-re...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: immediate-release 12 mg capsules for oral administration intervention 2: 60 mg immediate-release tablets for oral administration intervention 3: placebo capsules
intervention 1: phenylephrine intervention 2: pseudoephedrine intervention 3: placebo
0
null
117
0
0
0
NCT00276016
1COMPLETED
2006-02-01
2006-01-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
361
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This study compares the safety and efficacy of intravenous iron vs oral iron in subjects who display postpartum anemia.
This is an open label, Phase III, randomized, active controlled study of intravenous iron vs oral iron in anemic post partum patients.
Anemia
Anemia postpartum Postpartum anemia
null
2
arm 1: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Da...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42 intervention 2: A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum...
intervention 1: Oral iron tablets intervention 2: VIT-45
1
Norristown | Pennsylvania | United States | -75.3399 | 40.1215
352
0
0
0
NCT00396292
1COMPLETED
2006-02-01
2005-02-01
American Regent, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
45
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Wegener's granulomatosis is a primary systemic vasculitis characterized by granulomatous and necrotizing inflammation predominantly affecting the respiratory tract and the kidneys. Conventional therapy of Wegener's granulomatosis with cyclophosphamide and corticosteroids is limited by incomplete remissions and a high r...
null
Wegener's Granulomatosis
Wegener Granulomatosis Vasculitis Gusperimus Immunosuppression
null
1
arm 1: Gusperimus
[ 0 ]
1
[ 0 ]
intervention 1: SC, 0.5mg/kg/day, consecutive 21 days administration, 1 to 2 weeks rest, 6 cycles
intervention 1: Gusperimus
7
Prague | N/A | Czechia | 14.42076 | 50.08804 Copenhagen | N/A | Denmark | 12.56553 | 55.67594 Lübeck | N/A | Germany | 10.68729 | 53.86893 Maastricht | N/A | Netherlands | 5.68889 | 50.84833 Stockholm | N/A | Sweden | 18.06871 | 59.32938 Edinburgh | Scotland | United Kingdom | -3.19648 | 55.95206 Cambridge | N/A | Unit...
45
0
0
0
NCT00530075
1COMPLETED
2006-02-01
2003-12-01
Nippon Kayaku Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
144
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.
Objective: Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes. Design: Single-centre, prospective, randomized. Sample: One-hun...
Vulvovaginal Candidiasis
recurrent vulvovaginal candidiasis itraconazole classic homeopathy
null
3
arm 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). arm 2: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days. arm 3: CH treatment was provided by a licensed CH ...
[ 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) intervention 2: Lactobacillus vaginal tablets monthly given through 6 days intervention 3: CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised t...
intervention 1: itraconazole intervention 2: lactobacillus gasseri intervention 3: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)
1
Vienna | N/A | Austria | 16.37208 | 48.20849
144
0
0
0
NCT00895453
1COMPLETED
2006-02-01
2000-05-01
Medical University of Vienna
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
17
null
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls. The trial consisted of a screening visit, a treatment phase and a follow-up visit. All subjects were to be treated with study medication for 8 consecutive days. Blood and urine were co...
The screening visit was performed 2 to 21 days before the first administration of study medication, the treatment phase consisted of 12 days (of which study medication was administered during the first 8 days), and the follow-up visit was performed 15 to 19 days after the first administration of study medication.
Epilepsy
null
2
arm 1: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls arm 2: This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls
[ 5, 5 ]
1
[ 0 ]
intervention 1: None
intervention 1: BIA 2-093
1
Bloemfontein | Bloemfontein | South Africa | 26.214 | -29.12107
17
0
0
0
NCT02281526
1COMPLETED
2006-02-01
2005-05-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
352
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
null
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
null
Rhinitis, Vasomotor
Vasomotor Rhinitis VMR nonallergic rhinitis GW685698X
null
1
arm 1: GW685698X
[ 0 ]
1
[ 0 ]
intervention 1: Aqueous Nasal Spray 100mcg
intervention 1: GW685698X
53
Beverly Hills | California | United States | -118.40036 | 34.07362 Huntington Beach | California | United States | -117.99923 | 33.6603 Mission Viejo | California | United States | -117.672 | 33.60002 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32...
352
0
0
0
NCT00117325
1COMPLETED
2006-02-09
2005-07-11
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
350
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).
null
Vasomotor Rhinitis Rhinitis, Vasomotor
nonallergic rhinitis GW685698X VMR vasomotor rhinitis
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: GW685698X
59
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Irvine | California | United States | -117.82311 | 33.66946 Los Angeles | Califo...
347
0
0
0
NCT00118703
1COMPLETED
2006-02-09
2005-07-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
506
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to determine if Sarizotan HC1 1 mg b.i.d. (taken twice a day) is effective in the treatment of dyskinesia associated with dopaminergic treatment of Parkinson's disease (PD).
null
Parkinson's Disease Dyskinesia
Parkinson's Disease Dyskinesia Dyskinesia associated with dopaminergic treatment
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Subjects will receive sarizotan 1 milligram orally twice daily for 24 weeks. intervention 2: Subjects will receive placebo matched to sarizotan orally twice daily for 24 weeks.
intervention 1: Sarizotan intervention 2: Placebo
31
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 La Jolla | California | United States | -117.2742 | 32.84727 Oxnard | California | United States | -119.17705 | 34.1975 Sacramento | California | United States | -121.4944 | 38.58157 Englewood | Colora...
504
0
0
0
NCT00105508
1COMPLETED
2006-02-28
2004-09-30
EMD Serono
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
1,469
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ ...
null
Hepatitis C, Chronic
null
2
arm 1: None arm 2: None
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 400mg po bid for 16 weeks intervention 2: 400mg po bid for 24 weeks intervention 3: 180 micrograms sc weekly for 16 weeks intervention 4: 180 micrograms sc weekly for 24 weeks
intervention 1: Copegus intervention 2: Copegus intervention 3: peginterferon alfa-2a [Pegasys] intervention 4: peginterferon alfa-2a [Pegasys]
132
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Anchorage | Alaska | United States | -149.90028 | 61.21806 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Little Rock | Arkansas | U...
1,459
3
0.002056
1
NCT00077636
1COMPLETED
2006-03-01
2003-12-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0.0007
[ 4 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will evaluate the benefit of adding sertraline (Zoloft®) to Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) for sexually abused children who have Posttraumatic Stress Disorder (PTSD).
Adult research has demonstrated the efficacy of selective serotonin reuptake inhibitors (SSRIs) in decreasing Posttraumatic Stress Disorder (PTSD) symptoms; to date the SSRIs are the only medication class with demonstrated efficacy in treating all three PTSD symptom clusters (reexperiencing, avoidance, and hyperarousal...
Stress Disorders, Post-Traumatic
PTSD Depression Anxiety
null
2
arm 1: Trauma-Focused CBT provided individually to youth and parent for 12 sessions (90 minute sessions; 45 minutes for youth; 45 minutes for parent); plus Sertraline provided in dosage titrated as clinically indicated by child psychiatrist blind to treatment assignment, from 50mg/day to a maximum dosage of 150 mg/day ...
[ 0, 1 ]
3
[ 5, 0, 0 ]
intervention 1: 12 weeks of Trauma-Focused CBT (TF-CBT)for youth and parent intervention 2: 12 weeks of Sertraline pill, flexible dosage of 50-150 mg/day, to be administered while receiving TF-CBT intervention 3: 12 weeks of Placebo pill, flexible dosage, of 50-150 mg/day, to be administered while receiving TF-CBT
intervention 1: Trauma-Focused Cognitive Behavioral Therapy intervention 2: Sertraline Pill intervention 3: Placebo Oral Tablet
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
22
0
0
0
NCT00078767
1COMPLETED
2006-03-01
2001-04-01
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
57
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy, safety and tolerability of PEGASYS plus ribavirin in patients with CHC who could not tolerate or were not responsive to 12 weeks of therapy with PEG-Intron plus ribavirin. The anticipated time on study treatment is 1-2 years, and the target sample size is \>100 individuals.
null
Hepatitis C, Chronic
null
2
arm 1: Participants will receive Pegasys 180 micro grams (µg or mcg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day \[(mg/day), \< or \>=75 kilogram (Kg) body weight, respectively\], orally in divided doses for 60 weeks. arm 2: Participants will receive Pegasys 180 µg subcutaneously (SC) ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 1000/1200mg po bid for 36 or 60 weeks intervention 2: 180 micrograms weekly for 36 weeks (non-responders) or 60 weeks (non-tolerators)
intervention 1: Ribavirin intervention 2: peginterferon alfa-2a [Pegasys]
25
Bakersfield | California | United States | -119.01871 | 35.37329 Pasadena | California | United States | -118.14452 | 34.14778 San Diego | California | United States | -117.16472 | 32.71571 San Mateo | California | United States | -122.32553 | 37.56299 Bradenton | Florida | United States | -82.57482 | 27.49893 Miami | ...
57
0
0
0
NCT00087568
1COMPLETED
2006-03-01
2003-01-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
207
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Prolongation of the EPAAC™ trial - NCT00152464 (The Early Prevention of Asthma in Atopic Children). 36 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in young atopic children.
null
Asthma
Pediatry EPAAC atopic Children prevention of asthma Levocetirizine Xyzal
null
3
arm 1: Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ-LCTZ) arm 2: Placebo after having been randomized to Levocetirizine in the preceding A00309 trial - NCT00152464 (LCTZ - PLC) arm 3: Placebo after having been randomized to Placebo in the preceding A003...
[ 0, 2, 2 ]
2
[ 0, 10 ]
intervention 1: 5mg/mL oral drops, 0.125 mg/kg body weight, bid for 18 months intervention 2: Oral drops, bid for 18 months
intervention 1: LEVOCETIRIZINE intervention 2: Placebo
51
North Adelaide | N/A | Australia | 138.59141 | -34.90733 Parkville (North Melbourne) | N/A | Australia | 144.95 | -37.78333 Brussels | N/A | Belgium | 4.34878 | 50.85045 Brno | N/A | Czechia | 16.60796 | 49.19522 Hradec Králové | N/A | Czechia | 15.83277 | 50.20923 Olomouc | N/A | Czechia | 17.25175 | 49.59552 Ostrava ...
207
0
0
0
NCT00160563
6TERMINATED
2006-03-01
2004-06-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
23
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
1FEMALE
false
The purpose of this study is to compare post-operative pain after anesthesia with either isoflurane or propofol. Each group will be further randomized to receive intranasal nicotine or placebo in order to detect potential pronociceptive action of isoflurane. The study is a randomized, prospective, double-blinded contr...
A. Study Proposal and Rational The purpose of this study is to determine whether intranasal nicotine can decrease the negative side effects of the general anesthetic isoflurane. Isoflurane and other volatile anesthetics are potent antagonists of central nicotinic receptors. Nicotinic receptors are inhibited by isoflur...
Postoperative Pain
Postoperative pain
null
2
arm 1: Propofol anesthetic with and without nicotine arm 2: isoflurane anesthetic with and without nicotine
[ 0, 0 ]
1
[ 0 ]
intervention 1: nicotine nasal spray (3mg) before surgery
intervention 1: Nicotine (drug)
1
New York | New York | United States | -74.00597 | 40.71427
20
0
0
0
NCT00232817
1COMPLETED
2006-03-01
2003-07-01
Columbia University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
70
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study investigates whether sirolimus could decrease the rate of hepatoma recurrence after liver transplantation in high risk hepatoma patients.
A total of 70 patients with HCC (mean age: 54.6 years, female/male: 12/58) received a liver transplant and were included in the study. Immunosuppression included de novo sirolimus, low-dose calcineurin inhibitor for 6 to 12 months, with short-course (3 months) or no steroids.
Liver Carcinoma
liver transplant hepatocellular carcinoma sirolimus
null
1
arm 1: Sirolimus given intravenously or orally to achieve serum level of 12-20ug/l
[ 0 ]
1
[ 0 ]
intervention 1: Sirolimus given intravenously or orally to achieve target levels of 12-20ug/l
intervention 1: Sirolimus
1
Edmonton | Alberta | Canada | -113.46871 | 53.55014
70
0
0
0
NCT00328770
1COMPLETED
2006-03-01
1996-12-01
University of Alberta
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Chronic foot ulcers occurring among diabetic patients are difficult to heal. The frequent elderly age with co-morbidities, vascular insufficiencies, peripheral neuropathies and super imposed infections, all contribute towards the chronicity and failure of treatment. Preserving the ulcerated limb is the patients' wish. ...
null
Diabetic Foot Ulcer Amputation
Diabetic Foot Ulcer Traditional Chinese Medicine
null
2
arm 1: 12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day. arm 2: Placebo was made with starch and colouring materials. Given to patient orally twice a day
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients. The formula consisted of 12 herbs, viz: Radix astragali, Rhizoma atractylodis marcocephala...
intervention 1: TCM intervention 2: Placebo
2
Hong Kong | N/A | China | 114.17469 | 22.27832 Hong Kong | N/A | China | 114.17469 | 22.27832
80
0
0
0
NCT00393510
1COMPLETED
2006-03-01
2000-11-01
Chinese University of Hong Kong
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
66
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to investigate the efficacy and safety of Cycloset® and placebo when added to metformin monotherapy (at least 1000 mg/day for 3 months prior to screening) in persons with type 2 diabetes mellitus who are not adequately controlled on metformin therapy alone.
In the previously conducted Phase III clinical trials, Cycloset® (up to a maximum dose of 4.8 mg/day), administered either as monotherapy or combined with sulfonylurea therapy, significantly reduced HbA1c, fasting and post-prandial glucose and fasting and post-prandial triglycerides in obese individuals with type 2 dia...
Type 2 Diabetes
diabetes diabetes mellitus
null
2
arm 1: Bromocriptine mesylate 0.8 mg arm 2: Bromocriptine mesylate 0.8 mg matching placebo
[ 1, 2 ]
1
[ 0 ]
intervention 1: 0.8 mg tablet
intervention 1: Bromocriptine Mesylate
0
null
66
0
0
0
NCT00441363
6TERMINATED
2006-03-01
2005-02-01
VeroScience
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
This was a phase 1, double-blind, 4-way crossover study in healthy male and female volunteers. Subjects received 4 formulations of intranasal ketorolac tromethamine 30 mg. There was a wash-out period of 3-7 days between each dose. On Day 1 of each period subjects were randomised to receive either a single intranasal do...
null
Healthy Volunteers
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 30 mg Ketorolac Tromethamine intranasal (IN) intervention 2: 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN intervention 3: 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
intervention 1: Ketorolac Tromethamine intervention 2: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) intervention 3: Ketorolac Tromethamine with 5% Lidocaine HCl intervention 4: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl
1
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
64
0
0
0
NCT01355588
1COMPLETED
2006-03-01
2005-08-01
Egalet Ltd
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
215
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
null
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm \[recombinant follicle stimulating hormone (r-FSH)\] liquid formulation, in common setting for ovulation induction (OI) and also in in-vitro fertilization (IVF).
null
Infertility Ovulation Induction In-Vitro Fertilization
Infertility Ovulation induction Gonal-F Follitropin alpha Controlled ovarian stimulation
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro...
intervention 1: GONAL-f®
1
Darmstadt | N/A | Germany | 8.65027 | 49.87167
215
0
0
0
NCT01183143
1COMPLETED
2006-03-02
2004-05-11
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
198
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study was to demonstrate in adult participants faster recovery from a neuromuscular block induced by either rocuronium or vecuronium after reversal at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first...
null
Anesthesia, General
null
4
arm 1: After the last dose of rocuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was administered arm 2: After the last dose of rocuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was administered arm 3: After the last dose of vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammade...
[ 0, 1, 0, 1 ]
2
[ 0, 0 ]
intervention 1: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 2.0 mg/kg sugammadex was to be administered intervention 2: After the last dose of rocuronium or vecuronium, at reappearance of T2, a dose of 50 ug/kg neostigmine was to be administered
intervention 1: Sugammadex intervention 2: Neostigmine
0
null
189
0
0
0
NCT00451217
1COMPLETED
2006-03-06
2005-11-17
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
514
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The Early Prevention of Asthma in Atopic Children (EPAAC™). 24 months study to evaluate the efficacy and safety of levocetirizine (LCTZ) in preventing the onset of asthma in 12 to 24 months old children.
null
Dermatitis, Atopic
EPAAC Atopic children Asthma XYZAL Levocetirizine
null
2
arm 1: 0.125 mg/kg of Levocetirizine (LCTZ) were administered as oral drops twice daily. arm 2: Placebo was administered as oral drops twice daily.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Pharmaceutical form: Oral drops Route of administration: Oral use intervention 2: Pharmaceutical form: Oral drops Concentration: 5 mg/ml Route of administration: Oral use
intervention 1: Placebo intervention 2: Levocetirizine
0
null
510
0
0
0
NCT00152464
1COMPLETED
2006-03-15
2002-03-20
UCB Pharma SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
385
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will examine the viral kinetics and pharmacokinetics of Pegasys plus ribavirin and PEG-Intron plus ribavirin in interferon-naive patients with CHC. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
null
Hepatitis C, Chronic
null
2
arm 1: Participants received Peginterferon alfa-2a (40 kD) \[Pegasys\] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin \[Copegus\] 1000 or 1200 milligram (mg)/day), orally, \[according to body weight, lesser than or greater than/equal to (\< or \>/=) 75 kilogram (kg), respectively\] t...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1000/1200mg/day po intervention 2: 1.5 micrograms/kg sc weekly intervention 3: 1000/1200mg/day po intervention 4: 180 micrograms sc weekly
intervention 1: Ribavirin intervention 2: Peginterferon alfa-2b (PEG-Intron) intervention 3: Ribavirin intervention 4: Peginterferon alfa-2a [Pegasys]
41
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 San Diego | California | United States | -117.16472 | 32.71571 San Franc...
377
0
0
0
NCT00087607
1COMPLETED
2006-04-01
2004-01-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
58
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
Identifying new approaches for preventing breastmilk transmission of HIV-1 is an important research priority. To this end, clinical trials are underway to evaluate the efficacy of HAART (zidovudine, lamivudine, nevirapine) during late pregnancy/lactation versus zidovudine/nevirapine peripartum for prevention of breastm...
This will be a randomized study comparing breastfeeding women receiving zidovudine/nevirapine (from 36 weeks to delivery/first day postpartum) to women receiving HAART (zidovudine, nevirapine, lamivudine) initiated at 36 weeks and continuing throughout lactation (recommended for 6 months, breastfeeding cessation prior ...
HIV Infections
breastmilk HIV-1 antiretroviral mother-to-child transmission
null
2
arm 1: Combined short-course Zidovudine/Nevirapine arm 2: HAART during pregnancy and 6 months postpartum
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 300 mg of ZDV was given twice daily from 34 weeks gestation until labor then every 3 hours until delivery; 200 mg of NVP was given as a single oral dose at the onset of labor; and a single 2 mg/kg (6 mg if birthweight \> 2.5 kg) oral dose of NVP suspension was administered to the infant within 72 hours ...
intervention 1: Combined short-course zidovudine/nevirapine intervention 2: HAART
1
Nairobi | N/A | Kenya | 36.81667 | -1.28333
50
0
0
0
NCT00167674
1COMPLETED
2006-04-01
2003-11-03
University of Washington
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
41
RANDOMIZED
PARALLEL
2DIAGNOSTIC
4QUADRUPLE
false
0ALL
true
The aim of the study is to investigate the efficacy and safety of EGb 761® in patients with the primary Raynaud phenomenon, with regards to the frequency, duration and severity of vasospastic attacks.
Despite more than 150 years of research into the pathophysiology of Raynaud´s phenomenon it is still not understood sufficiently. Three mean mechanisms responsible for Raynaud´s phenomenon are discussed and fall into the following three categories: * neurological malfunction * pathological blood vessel wall and blood ...
Raynaud Disease
Raynaud´s phenomenon Vasospastic attacks Ginkgo biloba
null
2
arm 1: Receiving daily Ginkgo biloba extract EGb 761 arm 2: Receiving daily placebo
[ 0, 2 ]
1
[ 0 ]
intervention 1: daily Ginkgo biloba extract EGb 761
intervention 1: Ginkgo biloba extract EGb 761
1
Nijmegen | Gelderland | Netherlands | 5.85278 | 51.8425
41
0
0
0
NCT00251238
1COMPLETED
2006-04-01
2005-11-01
VSM Geneesmiddelen b.v.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
551
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of the study is to assess the efficacy comparability of cetirizine and levocetirizine, by comparing the effects of single intake of the two drugs to placebo in reducing symptoms of seasonal allergic rhinitis (SAR) in ragweed sensitive adult subjects exposed to ragweed pollen in an Environmental Exposure Uni...
null
Rhinitis Allergic Seasonal
Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed
null
5
arm 1: A single dose of placebo was administered orally on Day 1. arm 2: A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. arm 3: A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. arm 4: A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. arm 5:...
[ 2, 0, 0, 0, 0 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: * Pharmaceutical form: Drops for oral administration * Route of administration: Oral use intervention 2: * Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use intervention 3: * Pharmaceutical form: Tablets for oral administration * Route of administration: Oral use i...
intervention 1: Placebo drops intervention 2: Placebo tablets matching to levocetirizine intervention 3: Placebo tablets matching to cetirizine intervention 4: Levocetirizine drops intervention 5: Levocetirizine tablets intervention 6: Cetirizine drops intervention 7: Cetirizine tablets
1
Kingston | Ontario | Canada | -76.48098 | 44.22976
551
0
0
0
NCT00291642
1COMPLETED
2006-04-01
2006-01-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
2
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Greater Occipital Nerve Blocks (GONB) are a common procedure used for the treatment of headache. The GONB procedure involves a series of injections into the greater occipital nerve (a spinal nerve located at the back of your head). The purpose of this study is to determine whether GONB is effective for the treatment of...
null
Migraine
null
2
arm 1: None arm 2: matching volume of saline injected
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: The injectors will infiltrate an area of 2cm along the occipital ridge centering around the occipital artery or around the site 1/3 from the mastoid to the inion. If the subject has a bilateral headache or the headache is known to switch sides then the block will be performed bilaterally. If the headach...
intervention 1: 0.5% bupivicaine and 2% lidocaine intervention 2: Saline placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
2
0
0
0
NCT00329732
6TERMINATED
2006-04-01
2006-03-01
Thomas Jefferson University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
126
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Allergic rhinitis(AR) is one of the most common allergic disorders throughout the world.The conventional therapies are effective in alleviating symptoms but the efficacy are limited and not persistent. Furthermonre, the cost and side-effect are known defects. A classical Chinese herbal formula, has been used for AR for...
It is a randomized, double-blind, placebo-controlled trial.
Perennial Allergic Rhinitis
Perennial Allergic rhinitis Traditional Chinese Medicine
null
2
arm 1: Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae,...
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: 4 weeks of treatment, dose of 1 g (two capsules), twice daily intervention 2: 4 weeks of colormatched placebo capsules, dose of 1 g (two capsules), twice daily
intervention 1: Shi-Bi-Lin intervention 2: Placebo
2
Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832 Hong Kong | N/A | Hong Kong | 114.17469 | 22.27832
126
0
0
0
NCT00456755
1COMPLETED
2006-04-01
2004-03-01
Chinese University of Hong Kong
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
36
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
null
The objective of this study is to compare the rate and extent of absorption of two Tramadol Contramid® OAD 300 mg controlled-release tablets from two different manufacturing sites, administered as 1 x 300 mg controlled-release tablet under fasting conditions. The effect of food on the to-be-marketed formulation was als...
null
Healthy
Healthy Subjects
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 1x300mg Tramadol Hydrochloride (HCl) tablet (Confab Laboratories), fasting condition. Taken for one treatment period only, then subjects switched treatment at each period as per randomization schedule. Results are presented per treatment group overall. intervention 2: 1x300mg Tramadol Hydrochloride (HCl...
intervention 1: Tramadol hydrochloride intervention 2: Tramadol HCl intervention 3: Tramadol HCl
0
null
108
0
0
0
NCT00834912
1COMPLETED
2006-04-01
2006-02-01
Labopharm Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
43
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
false
The objective of this study is to investigate the pharmacodynamics (as expressed in intraocular pressure \[IOP\]) of two formulations of tafluprost 0.0015% eyedrops (preserved and unpreserved) in patients with open-angle glaucoma or ocular hypertension. The primary aim of this study is to show that IOP reduction betwe...
null
Open-Angle Glaucoma Ocular Hypertension
Ocular hypertension
null
2
arm 1: None arm 2: None
[ 0, 0 ]
1
[ 0 ]
intervention 1: Eye drops, 0.015 mg/ml, once daily to affected eye(s)
intervention 1: Tafluprost 0.0015%
3
Oulu | N/A | Finland | 25.46816 | 65.01236 Regensburg | N/A | Germany | 12.10161 | 49.01513 Starnberg | N/A | Germany | 11.34416 | 48.00193
85
0
0
0
NCT00918346
1COMPLETED
2006-04-01
2005-09-01
Santen Oy
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
477
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of o...
This is a double-blind, multicentre, randomized, parallel group, dose-finding study of the efficacy, safety and tolerability of a once-daily 3-day regimen of PA with a 3:1 weight/weight ratio for patients with acute, symptomatic, uncomplicated P. falciparum malaria. Patients will be recruited from 5 to 7 study sites in...
Plasmodium Falciparum Malaria
malaria antimalarial artemisinin based combination therapy (ACT) pyronaridine artesunate (Pyramax)
null
3
arm 1: pyronaridine tetraphosphate 6 mg/kg and artesunate 2 mg/kg arm 2: pyronaridine tetraphosphate 9 mg/kg and artesunate 3 mg/kg arm 3: pyronaridine tetraphsophate 12 mg/kg and artesunate 4 mg/kg
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.
intervention 1: pyronaridine/artesunate
6
Pailin | N/A | Cambodia | 102.60928 | 12.84895 Tomohon | North Sulawesi | Indonesia | 124.80379 | 1.31678 Guédiawaye | N/A | Senegal | -17.40212 | 14.77446 Bangkok | N/A | Thailand | 100.50144 | 13.75398 Farafenni | N/A | The Gambia | -15.6 | 13.56667 Mbarara | N/A | Uganda | 30.64851 | -0.60467
476
0
0
0
NCT01594931
1COMPLETED
2006-04-01
2005-07-01
Medicines for Malaria Venture
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
35
null
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to characterize the pharmacokinetics of Eslicarbazepine acetate in children and adolescents with epilepsy.
This clinical study was planned to be performed as an open-label, single-centre, multiple-dose study, in 30 paediatric epileptic patients distributed by 3 age groups of 10 patients each: 2-6 years \[Group 1\], 7-11 years \[Group 2\], and 12-17 years \[Group 3\]. The study was constituted by a 4-week baseline phase, fo...
Epilepsy
Epilepsy BIA 2-093
null
3
arm 1: At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5-8 and 30 mg/kg/day or 1...
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route
intervention 1: BIA 2-093 (Eslicarbazepine acetate)
1
Bucharest | N/A | Romania | 26.10626 | 44.43225
31
0
0
0
NCT02170064
1COMPLETED
2006-04-01
2005-06-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
19
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of rhuMab 2C4 (Perjeta) and docetaxel (Taxotere) in participants with advanced solid tumors that have progressed during or after standard therapy, or for which no standard therapy is available. Participants will be enrolled and e...
null
Solid Tumor
null
3
arm 1: Docetaxel will be administered via intravenous (IV) infusion on Day 1 of each 3-week cycle at a dose of 100 mg/m\^2 per day, and rhuMab 2C4 will be given on Day 1 of each 3-week cycle as a fixed-dose 420-mg IV infusion. For Cycle 1 only, rhuMab 2C4 administration will be delayed to Day 2 with an initial 840-mg l...
[ 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m\^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal. intervention 2: Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV...
intervention 1: Docetaxel intervention 2: RhuMab 2C4
2
Rotterdam | N/A | Netherlands | 4.47917 | 51.9225 Sutton | N/A | United Kingdom | -0.2 | 51.35
19
0
0
0
NCT02490475
1COMPLETED
2006-04-01
2004-02-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
78
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to assess the safety and efficacy of interferon-gamma by subcutaneous injection in complex treatment of patients with co-infection of HIV and pulmonary tuberculosis and to determine the rational of its use.
Study will evaluate safety and efficacy of the investigational medical product (IMP) - interferon-gamma - in participants with HIV-infection and pulmonary tuberculosis. Interferon-gamma (immune interferon) is an important anti-inflammatory cytokine produced by NK-cells, CD4 Th1 cells and CD8 cytotoxic supressor cells....
HIV Coinfection Aids/Hiv Problem Tuberculosis, Pulmonary Human Immunodeficiency Virus Lentivirus Infections RNA Virus Infections
interferon gamma, IFN-g, HIV infection, tuberculosis
null
3
arm 1: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,000 IU alternated with Interal® (interferon alpha) 3,000,000 IU every other day Interventions: Drug: Ingaron® Drug: Interal® Drug: Antituberculosis complex therapy arm 2: All participants receive subcutaneous interferon-gamma (Ingaron®) 500,...
[ 0, 0, 4 ]
1
[ 0 ]
intervention 1: received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
intervention 1: Interferon-Gamma
2
Saint Petersburg | Sankt-Peterburg | Russia | 30.31413 | 59.93863 Saint Petersburg | Sankt-Peterburg | Russia | 30.31413 | 59.93863
78
0
0
0
NCT05065905
1COMPLETED
2006-04-06
2006-01-19
SPP Pharmaclon Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
248
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
false
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All...
null
Bronchospasm Activity/Exercise Induced Bronchospasm
asthma bronchospasm
null
2
arm 1: Participants received FSC 100/50 microgram (mcg) one inhalation as a combination product via DISKUS, twice daily in morning after awakening and in evening for up to 28 days arm 2: Participants received FP 100 mcg one inhalation via DISKUS, twice daily in morning after awakening and in evening for up to 28 days.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Fluticasone propionate/salmeterol intervention 2: Fluticasone Propionate
intervention 1: Fluticasone propionate/salmeterol intervention 2: Fluticasone Propionate
50
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Huntington Beach | California | United States | -117.99923 | 33.6603 Orange | California | United States | -117.85311 | 33.78779 Palmdale | California | United States | -118.11646 | 34.57943 Paramount | California | United States | -118.15979 | 33.88946 San ...
248
0
0
0
NCT00118716
1COMPLETED
2006-04-23
2003-12-23
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
9
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This was a Phase 1, single-arm, open-label, pilot study of NY-ESO-1 protein vaccination with imiquimod as an adjuvant in patients with resected Stage IIB, IIC, and III malignant melanoma. The primary study objective was to determine the safety of NY-ESO-1 protein/imiquimod treatment, and the secondary objective was to ...
Patients applied imiquimod (250 mg) topically to a designated area of healthy skin on the upper inner arm or inner thigh (the cream remained on the skin overnight for 6-10 hours) every day for 5 consecutive days (i.e., for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4). The NY-ESO-1 protein (100 μg...
Malignant Melanoma
Malignant melanoma Stages IIB-III
null
1
arm 1: Patients applied topical imiquimod followed by vaccination with intradermal injections of the NY-ESO-1 protein.
[ 0 ]
2
[ 0, 2 ]
intervention 1: Patients applied imiquimod cream at bedtime every day for 5 consecutive days (for the first 5 days of Cycles 1-3 and for the first 4 days of Cycle 4) at a dose of 250 mg as supplied in single-use packets to a 4 x 5 cm area of healthy skin, alternating among the extremities (upper inner arms and inner th...
intervention 1: Imiquimod intervention 2: NY-ESO-1 protein
1
New York | New York | United States | -74.00597 | 40.71427
9
0
0
0
NCT00142454
1COMPLETED
2006-04-25
2005-08-24
Ludwig Institute for Cancer Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
521
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.
null
Diabetes Mellitus, Type 2
null
3
arm 1: Sitagliptin 100 mg arm 2: Sitagliptin 200 mg arm 3: Placebo/Pioglitazone
[ 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: sitagliptin 100 mg oral tablet once daily for 54 weeks intervention 2: sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks intervention 3: placebo oral tablet once daily during Phase A (Weeks 0-18) intervention 4: pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
intervention 1: Comparator: sitagliptin 100 mg intervention 2: Comparator: sitagliptin 200 mg intervention 3: Comparator: placebo intervention 4: Comparator: pioglitazone
0
null
521
0
0
0
NCT00094757
1COMPLETED
2006-04-28
2004-10-06
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
104
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Objective(s) The primary study objective is to assess the antiviral effect of 12 weeks of adefovir dipivoxil treatment in Korean patients with chronic hepatitis B and compensated liver disease. The secondary study objectives are to assess the antiviral effect, clinical benefit and safety of 52 weeks of adefovir dipivox...
null
Hepatitis B, Chronic
null
1
arm 1: All enrolled subject were enrolled to adefovir dipivoxil 10mg arm.
[ 0 ]
1
[ 0 ]
intervention 1: All enrolled subjects were enrolled to adefovir dipivoxil arm.
intervention 1: Adefor dipivoxil
0
null
104
0
0
0
NCT01205165
1COMPLETED
2006-04-28
2004-12-17
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
2,101
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcuta...
null
Arthroplasty, Replacement, Knee Thromboembolism
null
3
arm 1: 220 mg once daily arm 2: 150 mg once daily arm 3: 40 mg once daily
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 40 mg once daily intervention 2: 150 mg once daily intervention 3: 220 mg once daily
intervention 1: enoxaparin intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate
105
Garren | Australian Capital Territory | Australia | N/A | N/A Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Lismore | New South Wales | Australia | 153.2773 | -28.81354 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Toorak Gardens | South Australia | Australia | 138.63639 | -34.93478 ...
2,076
1
0.000482
0
NCT00168805
1COMPLETED
2006-05-01
2004-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000085
[ 5 ]
308
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
This study will evaluate whether an early positive response to once-monthly oral ibandronate in treatment-naive participants with postmenopausal osteoporosis is predictive of efficacy later in treatment. The anticipated time on study treatment is 6 months, and the target sample size is 360 individuals.
null
Post Menopausal Osteoporosis
null
2
arm 1: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 1 will receive a physician consultation after 4 months of treatment to review bone turnover test results. arm 2: Participants will receive a 6-month regimen with oral ibandronate, 150 mg once monthly. Group 2 will not r...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
intervention 1: Ibandronate
53
Montgomery | Alabama | United States | -86.29997 | 32.36681 Chandler | Arizona | United States | -111.84125 | 33.30616 Peoria | Arizona | United States | -112.23738 | 33.5806 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Pine Bluff | Arkansas | United States | -92.0032 | 34.22843 Anaheim | California | U...
308
1
0.003247
1
NCT02598934
1COMPLETED
2006-05-01
2004-08-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.000573
[ 3 ]
35
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II ...
OBJECTIVES: Primary * Determine the effects of hepatic enzyme-inducing drugs, such as anticonvulsants, on the pharmacokinetics of celecoxib in patients with newly diagnosed glioblastoma multiforme undergoing radiotherapy. * Determine the effects of steroids on the pharmacokinetics of celecoxib in these patients. Sec...
Brain and Central Nervous System Tumors
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma
null
2
arm 1: on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine) celecoxib and radiation therapy will be adminstered with this arm arm 2: not on p450 inhibitor (Patients either N...
[ 1, 1 ]
2
[ 4, 0 ]
intervention 1: Radiation is standard treatment 6000cGy in 30 fractions. Patients will receive celecoxib 400 mg bid during RT treatment intervention 2: Celecoxib will begin 1 week prior to RT at 400mg bid orally. One day 1 only 1 dose will be administered. Starting on day 2 and throughout treatment until progression, 2...
intervention 1: radiation therapy intervention 2: Celecoxib
7
Tampa | Florida | United States | -82.45843 | 27.94752 Atlanta | Georgia | United States | -84.38798 | 33.749 Baltimore | Maryland | United States | -76.61219 | 39.29038 Boston | Massachusetts | United States | -71.05977 | 42.35843 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cleveland | Ohio |...
35
0
0
0
NCT00068770
6TERMINATED
2006-05-01
2003-10-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
462
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maxi...
Benign Prostatic Hyperplasia
Benign prostatic hyperplasia, alpha blocker
null
2
arm 1: Silodosin 8 mg/Day with food arm 2: Matching placebo capsule once daily with food
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 8 mg daily for 12 weeks intervention 2: One capsule daily for 12 weeks
intervention 1: Silodosin intervention 2: Placebo
42
Birmingham | Alabama | United States | -86.80249 | 33.52066 Carmichael | California | United States | -121.32828 | 38.61713 Fresno | California | United States | -119.77237 | 36.74773 Laguna Woods | California | United States | -117.72533 | 33.6103 San Bernardino | California | United States | -117.28977 | 34.10834 Tar...
462
0
0
0
NCT00224120
1COMPLETED
2006-05-01
2005-05-01
Watson Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
420
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to investigate the efficacy and safety of an MK 0974 for migraine headache and to identify an appropriate dose range for further study.
null
Migraine
null
9
arm 1: Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache. arm 2: MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moder...
[ 2, 0, 0, 0, 0, 0, 0, 0, 1 ]
9
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Placebo to match assigned treatment arm; one orally-administered dose intervention 2: MK0974 25 mg; one orally-administered dose intervention 3: MK0974 50 mg; one orally-administered dose intervention 4: MK0974 100 mg; one orally-administered dose intervention 5: MK0974 200 mg; one orally-administered d...
intervention 1: Comparator: Placebo intervention 2: MK0974 intervention 3: MK0974 intervention 4: MK0974 intervention 5: MK0974 intervention 6: MK0974 intervention 7: MK0974 intervention 8: MK0974 intervention 9: Rizatriptan
0
null
330
0
0
0
NCT00246337
1COMPLETED
2006-05-01
2005-11-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 5 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a randomized, double-blind, double-dummy, placebo-controlled, parallel-group, single center study in subjects with positive histamine skin prick test and a positive RadioAllergoSorbent Test (RAST) (class \> 2) to one of the tested standardized allergenic extracts: tree pollen, cat dander, house dust mite, or a ...
null
Hypersensitivity
Histamine H1 Antagonists Anti-Allergic Agents
null
3
arm 1: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 2: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4). arm 3: Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (v...
[ 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 5 mg tablet once daily intervention 2: 5 mg capsule once daily intervention 3: once daily intervention 4: once daily
intervention 1: desloratadine intervention 2: levocetirizine intervention 3: Desloratadine placebo tablet intervention 4: Levocetirizine placebo capsule
0
null
36
0
0
0
NCT00359138
1COMPLETED
2006-05-01
2006-02-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
466
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms
null
Dermatitis Eczema
Dermatitis Eczema Pruritus Xyzal Zyrtec Levocetirizine Cetirizine
null
2
arm 1: Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days arm 2: Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 1 Levocetirizine 5mg tablet per day before bedtime for 14 days intervention 2: 1 Cetirizine 10mg tablet per day before bedtime for 14 days. intervention 3: 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days intervention 4: 1 Placebo-Cetirizine tablet per day before bedtime for 14 days in...
intervention 1: Levocetirizine intervention 2: Cetirizine intervention 3: Placebo-Levocetirizine intervention 4: Placebo-Cetirizine intervention 5: Standard topical steroid (1% hydrocortisone) ointment
3
Gyeunggi-do | N/A | South Korea | N/A | N/A Kyeonggi-Do | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566
423
0
0
0
NCT00375713
1COMPLETED
2006-05-01
2005-10-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
true
0ALL
false
The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.
null
Asthma
Pediatric asthma
null
4
arm 1: Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 ...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol. intervention 2: Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol....
intervention 1: Budesonide Inhalation Suspension intervention 2: MAP0010 low dose intervention 3: MAP0010 intermediate dose intervention 4: MAP0010 high dose
1
Brisbane | Queensland | Australia | 153.02809 | -27.46794
64
0
0
0
NCT00627679
1COMPLETED
2006-05-01
2005-12-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
292
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This 4 arm study will evaluate the efficacy and safety of RO4607381 when co-administered with pravastatin in patients with low or relatively low HDL-C levels. Patients will be randomised to one of 4 groups to receive either RO4607381 300mg, 600mg or 900mg po daily, or placebo po daily, for 12 weeks.All patients will al...
null
Dyslipidemia
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: po daily for 12 weeks intervention 2: 40mg po daily for 12 weeks intervention 3: 300mg po daily for 12 weeks intervention 4: 600mg po daily for 12 weeks intervention 5: 900mg po daily for 12 weeks
intervention 1: Placebo intervention 2: Pravastatin intervention 3: Dalcetrapib intervention 4: Dalcetrapib intervention 5: Dalcetrapib
33
Mobile | Alabama | United States | -88.04305 | 30.69436 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Newark | Delaware | United States | -75.74966 | 39.68372 Miami | Florida | United States | -80.19366 | 25.77427 Chicago | Illinois | United States | -87.65005 | 41.85003 Evansville | Indiana | United Sta...
292
0
0
0
NCT00697203
1COMPLETED
2006-05-01
2005-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
594
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The objective of this study is to evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Evaluate the safety and tolerability of VIT-45 in the treatment of Iron Deficiency Anemia
Anemia
null
2
arm 1: Day 0: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously. Day 7: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously. arm 2: Day 0: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 ...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 15 mg/kg up to a maximum dose of 1,000 mg of iron as VIT-45 over 15 minutes intravenously intervention 2: for weight \>33 kg, 250 cc of normal saline and for weight ≤33 kg, 100 cc of normal saline over 15 minutes intravenously
intervention 1: VIT-45 intervention 2: Placebo
1
Norristown | Pennsylvania | United States | -75.3399 | 40.1215
1,153
0
0
0
NCT00740246
1COMPLETED
2006-05-01
2005-07-01
American Regent, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
26
RANDOMIZED
CROSSOVER
null
1SINGLE
true
0ALL
false
This study investigated the relative bioavailability (rate and extent of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally d...
null
Healthy
Bioequivalence Healthy Subjects
null
2
arm 1: Donepezil Hydrochloride 10 mg Orally Disintegrating Tablets arm 2: Aricept® 10 mg Orally Disintegrating Tablets
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet
intervention 1: Donepezil Hydrochloride intervention 2: Aricept®
1
East Grand Forks | Minnesota | United States | -97.02452 | 47.92998
52
0
0
0
NCT01260922
1COMPLETED
2006-05-01
2006-04-01
Teva Pharmaceuticals USA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
26
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
This study investigated the relative bioavailability (rate and extend of absorption) of Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg by Teva Pharmaceuticals, USA with that of Aricept® Orally Disintegrating Tablets, Manufactured and Marketed by Eisai Inc., following a single oral dose (1 x 10 mg orally d...
null
Healthy
Bioequivalence Healthy Subjects
null
2
arm 1: Donepezil Hydrochloride Orally Disintegrating Tablets, 10 mg arm 2: Aricept® Orally Disintegrating Tablets, 10 mg
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 10 mg Orally Disintegrating Tablet intervention 2: 10 mg Orally Disintegrating Tablet
intervention 1: Donepezil Hydrochloride intervention 2: Aricept®
1
East Grand Forks | Minnesota | United States | -97.02452 | 47.92998
52
0
0
0
NCT01260948
1COMPLETED
2006-05-01
2006-04-01
Teva Pharmaceuticals USA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
232
RANDOMIZED
PARALLEL
2DIAGNOSTIC
3TRIPLE
false
0ALL
false
The object of this study is to compare four different dosages of Gadavist 1.0 in cardiac Magnetic Resonance Tomography (MRT) imaging with the imaging results of a cardiac SPECT examination in terms of diagnostic quality. For this purpose Gadavist dosages of 0.01 mmol/kg, 0.025 mmol/kg, 0.05 mmol/kg or 0.1mmol/kg body ...
null
Myocardial Perfusion Imaging Magnetic Resonance Imaging
Cardiac MRI gadobutrol
null
4
arm 1: Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg) intervention 2: 0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg) intervention 3: 0.05 mmol/kg BW (0.05 mL/kg) for str...
intervention 1: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 2: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 3: Gadobutrol (Gadavist,Gadovist, BAY86-4875) intervention 4: Gadobutrol (Gadavist,Gadovist, BAY86-4875)
14
Pölten | N/A | Austria | 15.96667 | 46.73333 Freiburg im Breisgau | Baden-Wurttemberg | Germany | 7.85222 | 47.9959 Tübingen | Baden-Wurttemberg | Germany | 9.05222 | 48.52266 Ulm | Baden-Wurttemberg | Germany | 9.99155 | 48.39841 München | Bavaria | Germany | 13.46314 | 48.69668 München | Bavaria | Germany | 13.46314 ...
226
0
0
0
NCT01490294
1COMPLETED
2006-05-01
2004-03-01
Bayer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 3 ]
64
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this trial is to establish the maximum maintenance dose of SPM 962 in patients with Parkinson's disease in a multi-center, uncontrolled, open-label study by conducting safety evaluation of each patient following once-daily transdermal doses of SPM 962 within a range of 4.5 to 36.0 mg. (The admi...
null
Parkinson's Disease
SPM 962 rotigotine Parkinson's disease
null
1
arm 1: SPM 962 transdermal patch
[ 0 ]
1
[ 0 ]
intervention 1: SPM 962 transdermal patch once a daily up to 36.0 mg/day
intervention 1: SPM 962
5
Kanto Region | N/A | Japan | N/A | N/A Kinki Region | N/A | Japan | N/A | N/A Kyushu Region | N/A | Japan | N/A | N/A Shikoku Region | N/A | Japan | N/A | N/A Tohoku Region | N/A | Japan | N/A | N/A
64
0
0
0
NCT01634243
1COMPLETED
2006-05-01
2005-01-01
Otsuka Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
null
Epilepsy, Partial
Epilepsy Partial onset seizures Seletracetam
null
1
arm 1: Escalating doses twice daily were to be administered.
[ 0 ]
1
[ 0 ]
intervention 1: * Pharmaceutical form: oral capsules * Concentration: 10 and 50 mg * Route of administration: oral administration
intervention 1: Seletracetam (ucb 44212)
7
Little Rock | Arkansas | United States | -92.28959 | 34.74648 San Francisco | California | United States | -122.41942 | 37.77493 Stanford | California | United States | -122.16608 | 37.42411 Columbus | Ohio | United States | -82.99879 | 39.96118 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Nashvil...
31
0
0
0
NCT00152451
1COMPLETED
2006-05-03
2005-05-19
UCB S.A. - Pharma Sector
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
59
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This trial will evaluate the efficacy and safety of UCB44212 as add-on therapy in subjects with focal epilepsy.
null
Epilepsy, Partial
Epilepsy Partial Onset Seizures Seletracetam Levetiracetam
null
1
arm 1: Escalating doses twice daily were to be administered.
[ 0 ]
1
[ 0 ]
intervention 1: * Pharmaceutical form: oral capsules * Concentration: 2, 10 and 50 mg * Route of administration: oral administration
intervention 1: Seletracetam (UCB44212)
17
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 St. Petersburg | Florida | United States | -82.67927 | 27.77086 Springfield | Illinois | United States | -89.64371 | 39.80172 Wichita | Kansas | United States | -97.33754 | 37.69224 Detroit | Michigan...
59
0
0
0
NCT00152503
1COMPLETED
2006-05-12
2005-08-31
UCB Pharma SA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
224
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of the study is to determine the time-course of recovery to a T4/T1 ratio of 0.9 within 4 minutes after 4.0 mg.kg\^-1 Sugammadex is administered at least 15 minutes after the last administration of rocuronium in a wide range of surgical procedures and anesthetic regimens (routine use). Safety evalua...
null
Anesthesia, General
null
1
arm 1: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was required after endotracheal intubation, maintenance dose(s) of 0.15 mg/kg rocuronium was administered. At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, a...
[ 0 ]
2
[ 0, 0 ]
intervention 1: At least 15 minutes after the intubation dose or the last maintenance dose of rocuronium, an intravenous single bolus dose of 4.0 mg/kg Org 25969 was administered. intervention 2: Each participant received an intravenous single bolus dose of 0.6 mg/kg rocuronium. If further neuromuscular block was requi...
intervention 1: Sugammadex intervention 2: Rocuronium
0
null
197
0
0
0
NCT00298831
1COMPLETED
2006-05-22
2005-10-27
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
189
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
An open-label, multi-center study to establish psoriasis control of moderate to severe plaque psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
null
Candidates for Systemic Therapy for Psoriasis Psoriasis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
intervention 1: Efalizumab
1
Geneva | N/A | Switzerland | 6.14569 | 46.20222
189
0
0
0
NCT00287118
1COMPLETED
2006-05-30
2004-10-27
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
2,615
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
To determine the comparative efficacy and safety of two different doses (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous, in prevention of venous thromboembolism in p...
null
Arthroplasty, Replacement, Knee Thromboembolism
null
3
arm 1: low dose regimen taken once daily arm 2: high dose regimen taken once daily arm 3: 30 mg subcutaneously twice daily
[ 0, 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: low dose regimen taken once daily intervention 2: low dose regimen taken once daily intervention 3: high dose regimen taken once daily intervention 4: high dose regimen taken once daily intervention 5: 30 mg subcutaneously twice daily
intervention 1: Dabigatran Dose 1 - day 2 to completion intervention 2: Dabigatran Dose 1 - day 1 intervention 3: Dabigatran Dose 2 - day 2 to completion intervention 4: Dabigatran Dose 2 - day 1 intervention 5: Enoxaparin
94
Birmingham | Alabama | United States | -86.80249 | 33.52066 Northport | Alabama | United States | -87.57723 | 33.22901 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Little Rock | Arkans...
2,596
1
0.000385
0
NCT00152971
1COMPLETED
2006-06-01
2004-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000068
[ 5 ]
418
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
An 8-week, open-label trial in 848 subjects at 212 sites to compare time to response in symptoms of anxiety in subjects treated with Niravam™ and a newly prescribed Selective Serotonin Reuptake Inhibitor (SSRI)or Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) to that in subjects treated with a newly prescribed ...
null
Generalized Anxiety Disorder Panic Disorder
null
4
arm 1: Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 2: Panic Disorder: Newly prescribed SSRI or SNRI alone arm 3: Generalized Anxiety Disorder: Niravam plus a newly prescribed SSRI or SNRI arm 4: Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
[ 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: Selective Serotonin Reuptake Inhibitor or Selective Norepinephrine Reuptake Inhibitor
intervention 1: Niravam intervention 2: SSRI/SNRI
1
Milwaukee | Wisconsin | United States | -87.90647 | 43.0389
414
1
0.002415
1
NCT00266409
1COMPLETED
2006-06-01
2005-10-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0.000427
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy. Sometimes the transplanted cells can make an immune response against the body's normal tissues. Cyclosporine and mycophenolate mofetil may prevent this from happening. PURPOSE:...
Primary objective: * Determine whether allogeneic peripheral blood stem cell transplantation with pre-conditioning low dose total body irradiation and fludarabine followed by cyclosporine and mycophenolate mofetil, when given to elderly patients with acute myeloid leukemia in first complete remission, is sufficiently ...
Leukemia
adult acute myeloid leukemia in remission adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with 11q23 (MLL) abnormalities
null
1
arm 1: patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - cyclosporine 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); mycophenolate mofetil 15mg/kg bid PO D0 to +27
[ 0 ]
6
[ 2, 0, 0, 0, 3, 4 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: None
intervention 1: therapeutic allogeneic lymphocytes intervention 2: cyclosporine intervention 3: fludarabine intervention 4: mycophenolate mofetil intervention 5: peripheral blood stem cell transplantation intervention 6: radiation therapy
83
Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Duarte | California | Un...
5
0
0
0
NCT00053014
6TERMINATED
2006-06-01
2003-04-01
SWOG Cancer Research Network
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
449
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with active SLE disease.
The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with active SLE disease. Patients were randomly assigned, following stratification ...
Lupus Erythematosus, Systemic
SLE
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo IV plus standard therapy (SOC) for SLE; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 52 weeks in the double-blind period. In the open-label extension period, placebo patients who opted to participate received belimumab 10 mg/kg IV plus SOC every 28 days for an add...
intervention 1: Placebo intervention 2: Belimumab 1 mg/kg intervention 3: Belimumab 4 mg/kg intervention 4: Belimumab 10 mg/kg
62
Birmingham | Alabama | United States | -86.80249 | 33.52066 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Tucson | Arizona | United States | -110.92648 | 32.22174 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles...
794
0
0
0
NCT00071487
1COMPLETED
2006-06-01
2003-10-01
Human Genome Sciences Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
862
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Study 0017 compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.
null
Staphylococcal Skin Infection
staph MRSA cSSSI
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Telavancin 10 mg/kg/day, IV for up to 14 days. intervention 2: Vancomycin 1 Gm IV q 12 hrs for up to 14 days.
intervention 1: Telavancin intervention 2: Vancomycin
1
National City | California | United States | -117.0992 | 32.67811
855
0
0
0
NCT00091819
1COMPLETED
2006-06-01
2005-01-01
Cumberland Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
36
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the vascular effects of two commonly used blood pressure medications, carvedilol and metoprolol in hypertensive patients with type 2 diabetes.
Carvedilol and metoprolol are two commonly used blood pressure medications that have both been shown to be effective in controlling hypertension. Although in the same drug class, preliminary data have shown that these medications may have different vascular effects. This study will assess which medication is better at ...
Hypertension Type 2 Diabetes Mellitus
beta-blockers endothelial function
null
2
arm 1: Carvedilol, orally, 25 mg, twice daily for five months arm 2: Metoprolol, orally, 200 mg, twice daily for five months.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 25 mg twice daily for five months. intervention 2: 200 mg twice daily for five months.
intervention 1: Carvedilol intervention 2: Metoprolol
1
Saint Paul | Minnesota | United States | -93.09327 | 44.94441
36
0
0
0
NCT00123604
1COMPLETED
2006-06-01
2004-06-01
St. Paul Heart Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
264
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
null
Rheumatoid Arthritis
oral JAK inhibitor clinical trial joint diseases anti-Inflammatory agents rheumatic diseases DMARD Antirheumatic Agents Autoimmune Diseases Immune System Diseases
null
4
arm 1: CP 690,550 5 mg BID arm 2: CP 690,550 15 mg BID arm 3: Oral tablets administered at a dose of 30 mg BID for 6 weeks arm 4: Placebo
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 10 ]
intervention 1: Oral tablets administered at a dose of 5 mg BID for 6 weeks intervention 2: Oral tablets administered at a dose of 15 mg BID for 6 weeks intervention 3: 30 mg BID for 6 weeks intervention 4: Placebo tablets
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: CP-690,550 intervention 4: Placebo
60
Upland | California | United States | -117.64839 | 34.09751 Clearwater | Florida | United States | -82.8001 | 27.96585 Miami | Florida | United States | -80.19366 | 25.77427 New Port Richey | Florida | United States | -82.71927 | 28.24418 Ocala | Florida | United States | -82.14009 | 29.1872 Orlando | Florida | United ...
264
0
0
0
NCT00147498
1COMPLETED
2006-06-01
2005-01-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
206
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This was a 22-week, prospective, randomized, double-blind, placebo-controlled, multicenter, parallel-group study that included a 4-week Baseline Phase at the beginning and a 4-week single-blind placebo Safety Phase at the end of the study.
null
Migraine Prophylaxis
null
2
arm 1: During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase). arm 2: During the Titration Phas...
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: None intervention 2: None
intervention 1: E2007 intervention 2: Placebo
9
Oceanside | California | United States | -117.37948 | 33.19587 Santa Monica | California | United States | -118.49138 | 34.01949 Tampa | Florida | United States | -82.45843 | 27.94752 West Palm Beach | Florida | United States | -80.05337 | 26.71534 Chicago | Illinois | United States | -87.65005 | 41.85003 Springfield |...
206
0
0
0
NCT00154063
1COMPLETED
2006-06-01
2005-01-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
62
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.
null
Rhinitis, Allergic, Perennial
Persistent Allergic Rhinitis HDM Parietaria sneezing rhinorrhea ocular pruritus Rhinasthma inflammatory cells ICAM-1 ATAREAL Xyzal Levocetirizine
null
2
arm 1: 5 mg of Levocetirizine (LCTZ) was taken orally once a day. arm 2: 5 mg of Levocetirizine (LCTZ) was taken whenever needed.
[ 0, 0 ]
1
[ 0 ]
intervention 1: * Pharmaceutical form: Tablet * Concentration: 5 mg * Route of administration: Oral use
intervention 1: Levocetirizine
1
Genova | N/A | Italy | 11.87211 | 45.21604
62
0
0
0
NCT00160680
1COMPLETED
2006-06-01
2005-03-01
UCB S.A. - Pharma Sector
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
45
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Subjects are scheduled to undergo a Greater Occipital Nerve Block (GONB) as treatment for your chronic daily headache (CDH). GONB has been used for many years in the treatment of headaches. The nerve block is done by injecting a liquid drug through the skin of the back of the head to the area of the greater occipital n...
null
Migraine
null
2
arm 1: Adult patients with CDH, and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and trigger point injections in the cervical paraspinal and the trapezius muscles bilaterally. arm 2: Adult patients with CDH, and headache of at least moderate intensity at time o...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: lidocaine, bupivicaine and saline-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc. intervention 2: lidocaine, bupivicaine and triamcinolone (steroid)-2 cc were injected to each GON and 0.5 cc to each trigger point. Total injected volume = 10 cc.
intervention 1: lidocaine, bupivicaine and saline intervention 2: lidocaine plus bupivicaine plus triamcinolone (steroid)
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
45
0
0
0
NCT00203294
1COMPLETED
2006-06-01
2005-06-01
Thomas Jefferson University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
3
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
Olanzapine (o-lan-zah-peen) is a medication that has been approved by the Food and Drug Administration (FDA) for the treatment of patients with schizophrenia and/ or bipolar disorder. The trade name for this drug is Zyprexa®. Olanzapine has not been approved by the FDA for the prevention of migraine and is experimental...
null
Migraine
null
2
arm 1: Olazepam arm 2: None
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: Olanzapine (5-10 mg) daily during first intervention period, then placebo(matching)druing second intervention period (after a washout period) intervention 2: Placebo (matching) during first intervention period, then olanzapine (5-10 mg. daily) during the second intervention period (after a washout phase...
intervention 1: Olanzapine during first intervention period and placebo during second intervention period intervention 2: Placebo during first intervention period, then olanzapine during second intervention period
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
3
0
0
0
NCT00203307
6TERMINATED
2006-06-01
2004-05-01
Thomas Jefferson University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
117
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The intent of this study is to demonstrate the efficacy and safety of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in newly or previously diagnosed CIDP subjects. Eight courses of treatment with either placebo or IGIV-C will occur every 3 weeks. Neurological function will be measu...
110 subjects, 55 per treatment group, with newly or previously diagnosed CIDP defined by INCAT neurophysiological diagnostic criteria will be enrolled into the trial. Patients will not be replaced if they discontinue prematurely.
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
Immunoglobulin G
null
2
arm 1: IGIV-C arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 g/kg body weight ideally over 2-4 days . Thereafter, study drug infusion (IGIV-C) will be administered every 3 weeks at a dose of 1 g/kg bw, given over 1-2 days for a total of 7 additional infusions intervention 2: Albumin 25%, USP diluted with dextrose 5% to a final concentration of 0.1% as an intrav...
intervention 1: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified intervention 2: Albumin (Human) 25%, United States Pharmacopeia (USP)
32
New Haven | Connecticut | United States | -72.92816 | 41.30815 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Winston-Salem | North Carolina | United States | -80.24422 | 36.09986 Cleveland | Ohio | United States | -81.69541 | 41.4995 Dallas | Texas...
208
0
0
0
NCT00220740
1COMPLETED
2006-06-01
2004-04-01
Grifols Therapeutics LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
82
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952) in a single dose application scheme. Subjects will undergo a 2 - 28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, s...
The objective of this trial is to evaluate safety and efficacy of rotigotine nasal spray (SPM 952)in a single dose application scheme. Subjects will undergo a 2-28 days screening period in which eligibility criteria will be checked. Subjects will then be hospitalized for one night. In the morning of the next day, subje...
Parkinson's Disease
Rotigotine Rotigotine nasal spray Efficacy, safety and tolerability Parkinson's disease
null
5
arm 1: Placebo nasal spray 1 - 4 puffs arm 2: Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine) arm 3: Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine) arm 4: Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine) arm 5: Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
[ 2, 0, 0, 0, 0 ]
2
[ 0, 10 ]
intervention 1: Rotigotine- HCl 2.5mg/mL nasal spray, dosage per puff of 275µg per 110µg administered in up to 4 deliveries intervention 2: placebo nasal spray 1, 2 3, and 4 puffs
intervention 1: Rotigotine nasal spray intervention 2: Placebo
0
null
82
0
0
0
NCT00296192
1COMPLETED
2006-06-01
2006-02-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
49
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study evaluates the safety and efficacy of plerixafor given in addition to granulocyte-colony stimulating factor (G-CSF) for collection of peripheral blood stem cells (PBSCs) for autologous transplantation in patients with non-Hodgkin's lymphoma (NHL) and multiple myeloma (MM). Efficacy outcomes include evaluation...
Participants with NHL and MM who have undergone prior cyto-reductive chemotherapy, are to be autologously transplanted, and meet the inclusion/exclusion criteria are eligible to enter the study. The only change to the standard of care is the addition of plerixafor to a granulocyte colony-stimulating factor (G-CSF) mobi...
Lymphoma, Non-Hodgkin Multiple Myeloma
Non-Hodgkin's Lymphoma Multiple Myeloma Stem cell mobilization
null
2
arm 1: Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for u...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Participants underwent mobilization with G-CSF 10 µg/kg/day for 4 days, administered by subcutaneous injection (SC) injection each morning. On the evening of Day 4, participants received a dose of plerixafor 240 µg/kg, administered by SC injection. On Day 5, participants returned to the clinic and recei...
intervention 1: G-CSF Plus Plerixafor
8
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Loa Angeles | California | United States | N/A | N/A Maywood | Illinois | United States | -87.84312 | 41.8792 Iowa City | Iowa | United States | -91.53017 | 41.66113 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Rochester | Minnesota | Unite...
49
0
0
0
NCT00322491
1COMPLETED
2006-06-01
2004-03-01
Genzyme, a Sanofi Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
456
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
null
This study compares of the safety and efficacy of intravenous iron vs oral iron in the treatment of anemia secondary to heavy uterine bleeding
This is an open-label, randomized, Phase III, active-control, study of the efficacy and safety of IV iron vs oral iron in patients with anemia secondary to heavy uterine bleeding.
Anemia
anemia heavy uterine bleeding menorrhagia Anemia secondary to heavy uterine bleeding
null
2
arm 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered arm 2: 325 mg tablets TID on Days 0 through Day 42
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered intervention 2: 325 mg tablets TID on Days 0 through Day 42
intervention 1: Ferric Carboxymaltose (FCM) intervention 2: Ferrous Sulfate tablets
1
Norristown | Pennsylvania | United States | -75.3399 | 40.1215
456
0
0
0
NCT00395993
1COMPLETED
2006-06-01
2005-05-01
American Regent, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0