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
[ 3, 4 ]
121
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
true
The objective of this proposal is to elucidate effects of bupropion SR + varenicline on smoking-cessation related processes in early abstinence using a human laboratory model. A within-subjects design will be used to assess the additive effects of bupropion and varenicline in 48 treatment seeking smokers \[bupropion SR...
null
Nicotine Dependence Nicotine Withdrawal
Tobacco Nicotine Smoking Varenicline Bupropion Human laboratory study Stress tolerance Startle response Cognitive assessment Progressive ratio Motivation
null
2
arm 1: Bupropion + Placebo Varenicline \\Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \\Bupropion + Placebo Varenicline arm 2: Bupropion + Varenicline \\Varenicline + Placebo Bupropion; Varenicline + Placebo Bupropion \\Bupropion + Varenicline
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Form: tablet, Dosage, Frequency, Duration: Days 1-3, 150 mg, q.d., Days 4-11, 150 mg, b.i.d. intervention 2: Form: tablet, Dosage, Frequency, Duration: Days 1-3, .5 mg, q.d., Days 4-7, .5 mg, b.i.d., Days 8-11, 1 mg, b.i.d.
intervention 1: Bupropion intervention 2: Varenicline
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
121
0
0
0
NCT00749658
1COMPLETED
2010-09-01
2008-11-01
University of Minnesota
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 ]
112
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Children and adolescents with Attention Deficit Hyperactivity Disorder (ADHD) who are not tolerating or not responding well to stimulant therapy will be included in this study. Two different strategies for transition from Stimulant to Atomoxetine will be used: Slow (10 weeks) and fast (2 weeks). Changes in ADHD symptom...
Study B4Z-EW-LYFJ is a phase IV multicentre, open label, controlled study in approximately 120 patients with ADHD from 6 years to 16 years of age. After the screening period, patients will be randomized (centrally in a 1:1 ratio) either to a transition period of 10 weeks (slow switching arm) or to a transition period o...
Attention Deficit Hyperactivity Disorder
ADHD Children Stimulant Atomoxetine Adolescents
null
2
arm 1: Slow Switching Group (switch from full stimulant dose to atomoxetine, 1.2 mg/kg/day, orally (PO), during 10 weeks then continue treatment up to 1.8 mg/kg/day, PO to 14 weeks arm 2: Fast Switching Group (switch from full stimulant dose to atomoxetine 1.2 mg/kg/day, PO, during 2 weeks then continue treatment up to...
[ 0, 0 ]
1
[ 0 ]
intervention 1: 1.2 mg/kg/day up to 1.8 mg/kg/day, orally (PO)
intervention 1: Atomoxetine
6
Milton | Queensland | Australia | 153.00312 | -27.47039 Zona Centro | N/A | Mexico | -99.14803 | 23.73126 Fife | Scotland | United Kingdom | N/A | N/A Sheffield | South Yorkshire | United Kingdom | -1.4659 | 53.38297 Birmingham | West Midlands | United Kingdom | -1.89983 | 52.48142 Northampton | N/A | United Kingdom | ...
111
0
0
0
NCT00760747
1COMPLETED
2010-09-01
2008-09-01
Eli Lilly and 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
[ 5 ]
184
RANDOMIZED
PARALLEL
null
1SINGLE
false
0ALL
false
The objective of the study is to assess how DisCoVisc Ophthalmic Viscosurgical Device (OVD) compares with Healon and Amvisc Plus in the protection of corneal endothelial cells, and the ability to maintain anterior chamber space, in routine cataract surgery.
null
Cataract
Cataract
null
3
arm 1: DisCoVisc® Ophthalmic Viscosurgical Device arm 2: Healon arm 3: Amvisc Plus
[ 0, 1, 1 ]
3
[ 1, 0, 0 ]
intervention 1: Injection of DisCoVisc® Ophthalmic Viscosurgical Device (OVD) into the anterior chamber prior to and throughout the cataract surgery procedure intervention 2: Injection of Healon into the anterior chamber prior to and throughout the cataract surgery procedure intervention 3: Injection of Amvisc Plus int...
intervention 1: DisCoVisc® intervention 2: Healon intervention 3: Amvisc Plus
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
184
0
0
0
NCT00763360
1COMPLETED
2010-09-01
2008-05-01
Alcon Research
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 ]
44
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
1FEMALE
true
This study is a feasibility and acceptability study assessing whether providing buprenorphine for women under criminal justice supervision leaving a controlled environment and returning to the community would prevent opioid relapse and reduce HIV risk behaviors.
This study sought to enroll opioid dependent women under supervision in the criminal justice system and in a controlled environment (substance abuse treatment)but at at high risk for opioid relapse and engaging in HIV risk behaviors when returning to the community. Initially, 9 women were enrolled and received buprenor...
Opioid Dependence HIV
opiates HIV
null
2
arm 1: Active sublingual buprenorphine provided to participants; dose as clinically indicated up to 32 mg daily for up to 3 months arm 2: Placebo sublingual medication provided to individuals randomized to control up to 3 months
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Placebo to match buprenorphine administered for 3 months intervention 2: Buprenorphine provided for 3 months; dosing was as clinically indicated up to 32 mg daily.
intervention 1: Placebo intervention 2: Buprenorphine
0
null
44
0
0
0
NCT00763958
1COMPLETED
2010-09-01
2008-05-01
University of Alabama at Birmingham
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 ]
2,591
RANDOMIZED
FACTORIAL
0TREATMENT
1SINGLE
true
0ALL
false
This study shall determine whether or not proactive telephone support for smoking cessation delivered to quitline callers is more effective than standard 'reactive' provision and whether or not the offer of a voucher for a cost free supply of nicotine replacement therapy (NRT) has any additional impact on smoking cessa...
There is evidence from other studies that telephone helplines are effective in helping individuals to stop smoking. This study will investigate whether or not two interventions that have been proven effective in other contexts are effective when offered via telephone helplines. The two interventions which will be teste...
Tobacco Smoking
Tobacco Cigarette Smoking Counselling Nicotine Replacement Therapy Telephone Quitline Helpline
null
4
arm 1: Standard 'Together Programme' telephone support for smoking cessation \& advice to obtain nicotine addiction treatment arm 2: Proactive support \& advice to obtain nicotine addiction treatment arm 3: Reactive telephone support (i.e. Together Programme) and offer of voucher for cost free Nicotine Replacement Ther...
[ 1, 1, 1, 1 ]
3
[ 5, 5, 0 ]
intervention 1: Pro-active telephone counselling allows for repeated, sequenced calls to be made by quitline counsellors to smokers and for counselling to be provided during accepted calls. intervention 2: Reactive counselling usually involves the provision of evidence-based information to support quit attempts without...
intervention 1: Proactive telephone support intervention 2: Reactive (standard) telephone support intervention 3: Offer of voucher for cost-free Nicotine Replacement Therapy
1
Nottingham | N/A | United Kingdom | -1.15047 | 52.9536
0
0
0
0
NCT00775944
1COMPLETED
2010-09-01
2009-02-01
University of Nottingham
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 ]
422
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This trial is conducted in North America. The aim of this clinical trial is to evaluate the potential of liraglutide to maintain long term weight loss in obese non-diabetic subjects, as well as in overweight subjects who have medical problems such as hypertension (high blood pressure) or dyslipidaemia (an abnormal amou...
null
Metabolism and Nutrition Disorder Obesity
null
2
arm 1: A 12-week run-in period where screened subjects were treated with a low calorie diet. Randomised subjects (those who lost more than or equal to 5% of screening body weight) were treated with liraglutide 3.0 mg, once daily, injected subcutaneously and instructed to follow a standard energy-restricted diet in the ...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Liraglutide 3.0 mg per day administered in a 6.0 mg/mL, 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily intervention 2: Liraglutide placebo 3 mL FlexPen® for subcutaneous (under the skin) injection, once daily
intervention 1: liraglutide intervention 2: placebo
37
Goodyear | Arizona | United States | -112.35821 | 33.43532 Peoria | Arizona | United States | -112.23738 | 33.5806 Huntington Beach | California | United States | -117.99923 | 33.6603 Montclair | California | United States | -117.68978 | 34.07751 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Hiale...
422
0
0
0
NCT00781937
1COMPLETED
2010-09-01
2008-10-30
Novo Nordisk A/S
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 ]
250
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Participants currently taking atorvastatin 20 mg will be switched to either atorvastatin 40 mg or ezetimibe/simvastatin 10 mg/40 mg (10/40). After 6 weeks of treatment, the percent reduction in low-density lipoprotein cholesterol (LDL-C) will be assessed and compared between the two treatment groups.
null
Hypercholesterolemia
null
2
arm 1: Participants received 20 mg open-label atorvastatin during a 5-week run-in period. Following this run-in period, ezetimibe/simvastatin 10/40 was administered once daily in tablet form during the 6-week double-blind treatment period arm 2: Participants received 20 mg open-label atorvastatin during a 5-week run-in...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: ezetimibe/simvastatin 10/40 tablet once daily for 6 weeks. intervention 2: atorvastatin 40 mg tablet once daily for 6 weeks intervention 3: All participants will take atorvastatin 20 mg tablet once daily for the 5 week run-in period before randomization
intervention 1: ezetimibe/simvastatin 10/40 intervention 2: atorvastatin 40 mg intervention 3: atorvastatin 20 mg
0
null
250
0
0
0
NCT00782184
1COMPLETED
2010-09-01
2008-11-01
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 ]
625
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (COPD). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compare...
null
Pulmonary Disease, Chronic Obstructive
null
3
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Olodaterol (BI1744) placebo inhaled orally once daily from the Respimat inhaler
intervention 1: Olodaterol (BI1744) intervention 2: Olodaterol (BI1744) intervention 3: placebo
54
Jasper | Alabama | United States | -87.27751 | 33.83122 Berkeley | California | United States | -122.27275 | 37.87159 Los Angeles | California | United States | -118.24368 | 34.05223 Fort Collins | Colorado | United States | -105.08442 | 40.58526 Stamford | Connecticut | United States | -73.53873 | 41.05343 DeLand | Fl...
624
0
0
0
NCT00782210
1COMPLETED
2010-09-01
2008-11-01
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
0
0
0
0
0
0
0
0
0
[ 4 ]
263
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to see whether droxidopa is effective in treating symptoms of neurogenic orthostatic hypotension in patients with Primary Autonomic Failure (Pure Autonomic Failure, Multiple System Atrophy, Parkinson's Disease), Non-diabetic neuropathy, or Beta Hydroxylase deficiency.
Systolic blood pressure is transiently and minimally decreased in healthy individuals upon standing. Normal physiologic feedback mechanisms work through neurally-mediated pathways to maintain the standing blood pressure, and thus maintain adequate cerebral perfusion. The compensatory mechanisms that regulate blood pres...
Symptomatic Neurogenic Orthostatic Hypotension (NOH) Non-diabetic Neuropathy Primary Autonomic Failure Dopamine Beta Hydroxylase Deficiency
NOH Neurogenic Orthostatic Hypotension Orthostatic hypotension PAF Pure Autonomic Failure MSA Multiple System Atrophy Neuropathy Autonomic Failure Parkinson Dopamine Deficiency Dopamine Droxidopa
null
2
arm 1: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day arm 2: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day ...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, three times per day 400 mg, oral, three times per day 500 mg, oral, three times per day 600 mg, oral, three times per day intervention 2: 100 mg, oral, three times per day 200 mg, oral, three times per day 300 mg, oral, th...
intervention 1: Placebo intervention 2: Droxidopa
21
Huntsville | Alabama | United States | -86.58594 | 34.7304 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Irvine | California | United States | -117.82311 | 33.66946 Bradenton | Florida | United States | -82.57482 | 27.49893 St. Petersburg | Fl...
425
0
0
0
NCT00782340
1COMPLETED
2010-09-01
2008-09-01
Chelsea 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
[ 3 ]
195
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
null
Ulcerative Colitis
treatment of ulcerative colitis; CP 690 550
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 10 ]
intervention 1: Administration via oral route twice daily for the duration of treatment intervention 2: Administration via oral route twice daily for the duration of treatment intervention 3: Administration via oral route twice daily for the duration of treatment intervention 4: Administration via oral route twice dail...
intervention 1: CP- 690 550 intervention 2: CP- 690 550 intervention 3: CP- 690 550 intervention 4: CP- 690 550 intervention 5: placebo
59
Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ghent | N/A | Belgium | 3.71667 | 51.05 Leuven | N/A | Belgium | 4.70093 | 50.87959 Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 Independencia | S...
194
0
0
0
NCT00787202
1COMPLETED
2010-09-01
2008-12-01
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 ]
221
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a Phase 2, doubled-masked, randomized study of the efficacy and safety of Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) in subjects with diabetic macular edema (DME). Approximately 200 subjects will be randomized in the US, Canada, Australia and EU.
Qualified subjects will be randomized to one of 5 treatment arms. The active (treatment) phase of the study will be 52 weeks, with a 6 month safety follow-up
Diabetic Macular Edema
null
5
arm 1: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) .5 mg every 4 weeks arm 2: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2 mg every 4 weeks arm 3: Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2mg every 4 weeks for 3 visits followed by every 8 weeks arm 4: Intravitreal Aflibe...
[ 0, 0, 0, 0, 1 ]
2
[ 3, 0 ]
intervention 1: laser every 16 weeks as needed intervention 2: None
intervention 1: Laser Photocoagulation intervention 2: Intravitreal Aflibercept Injection
47
Artesia | California | United States | -118.08312 | 33.86585 Beverly Hills | California | United States | -118.40036 | 34.07362 Mountain View | California | United States | -122.08385 | 37.38605 Pasadena | California | United States | -118.14452 | 34.14778 Sacramento | California | United States | -121.4944 | 38.58157 ...
219
0
0
0
NCT00789477
1COMPLETED
2010-09-01
2008-12-01
Regeneron 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 ]
198
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective is to evaluate the safety of long-term treatment with NP101 as assessed by: * Subject self-examination skin irritation scores * Adverse events * Changes in vital signs and ECG parameters The secondary objective is to evaluate the long term efficacy of NP101 as assessed by: * Headache pain free ...
null
Migraine Disorders
null
1
arm 1: sumatriptan iontophoretic transdermal patch
[ 0 ]
1
[ 0 ]
intervention 1: NP101 study patch 4 hour application
intervention 1: NP101
34
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Newport Beach | California | United States | -117.92895 | 33.61891 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.01949 ...
183
0
0
0
NCT00792103
1COMPLETED
2010-09-01
2009-01-01
NuPathe 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, 3 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study has the following objectives: Primary Objective * To evaluate the anti-lymphoma efficacy of daily oral doses of ITF2357 followed by intravenous Mechlorethamine administered to patients with refractory/relapsed Hodgkin's lymphoma. Secondary Objective \- To evaluate the safety and tolerability of multiple ...
This is a single-center, open label, phase II study aimed at testing the activity of multiple cycles of ITF2357 followed by Mechlorethamine administered to patients with relapsed/refractory Hodgkin's lymphoma. Patients will receive a maximum of twelve 3-week cycles of ITF2357 followed by Mechlorethamine according to t...
Hodgkin's Lymphoma
null
1
arm 1: Patients received the following therapy cycle * ITF2357, 50 mg every 6 hours, per os, days 1 - 3; * Mechlorethamine, 6 mg/sqm, intravenously , day 4. Therapy was administered every 21 days as long as there was no evidence of progressive disease or unacceptable toxicity, but in any case for a maximum of 12 cycle...
[ 0 ]
1
[ 0 ]
intervention 1: ITF2357, supplied as hard gelatine capsules for oral administration at the strength of 50 mg each.
intervention 1: ITF2357
1
Milan | N/A | Italy | 12.59836 | 42.78235
24
0
0
0
NCT00792467
1COMPLETED
2010-09-01
2008-02-01
Italfarmaco
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 ]
794
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The drug being studied, fesoterodine fumarate helps prevent the bladder neck opening at unwanted times and has been shown to help patients with overactive bladder syndrome pass urine less frequently than before treatment. It is postulated that this drug will also prove effective in elderly patients (aged \> 65 years) a...
null
Urinary Bladder, Overactive
Overactive bladder syndrome fesoterodine elderly flexible dose regimen urgency frequency urge urinary incontinence anticholinergic antimuscarinic
null
2
arm 1: Flexible dose regimen of placebo once daily. The dose can be increased after 4 weeks if clinically indicated. Subsequently the dose can be reduced to the original dose if clinically indicated. arm 2: Flexible dose regimen of fesoterodine fumarate 4mg once daily. The dose can be increased to 8mg once daily after ...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: placebo administered orally in the morning or evening. intervention 2: Fesoterodine fumarate is an antimuscarinic drug recently approved by the European Medicines Evaluation Agency for treatment of symptoms of overactive bladder syndrome.
intervention 1: Placebo intervention 2: Fesoterodine fumarate
60
Vienna | N/A | Austria | 16.37208 | 48.20849 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Edegem | N/A | Belgium | 4.44504 | 51.15662 Ghent | N/A | Belgium | 3.71667 | 51.05 Kortrijk | N/A | Belgium | 3.26487 | 50.82803 Aarhus N | N/A | Denmark | 10.17317 | 56.20367 Glostrup Municipality | N/A | Denmark | 12.40377 | 55...
1,439
0
0
0
NCT00798434
1COMPLETED
2010-09-01
2008-06-01
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 ]
130
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.
null
Chronic Plaque Psoriasis
Plaque psoriasis inflammatory skin disease skin condition, thickening flaking scaly patches skin disease
null
4
arm 1: Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29. arm 2: Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29. arm 3: Participants randomized to this arm received AIN457 3 mg/kg on days ...
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: AIN457 was administered intravenously. intervention 2: Matching placebo to AIN457 was administered intravenously.
intervention 1: AIN457 intervention 2: Placebo
0
null
100
0
0
0
NCT00805480
1COMPLETED
2010-09-01
2008-12-01
Novartis 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 ]
33
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study involves treating patients that have suffered an acute ischemic stroke with the medication donepezil (Aricept ®). The hypothesis is that taking donepezil (FDA-approved for the treatment of Alzheimer's Disease) for the first 90 days following a stroke enhances recovery.
We hypothesize that donepezil (5 mg per day, titrated up to 10 mg per day as tolerated) will enhance recovery following stroke by improving attention, learning and memory thereby enhancing rehabilitation. The null hypothesis is that the probability of a favorable outcome among post-stroke donepezil users is equal to th...
Ischemic Stroke
Ischemic stroke treatment recovery donepezil Aricept
null
1
arm 1: Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
[ 0 ]
1
[ 0 ]
intervention 1: Study participants will be treated with donepezil orally at an initial dose of 5 mg daily for the first 4 weeks, then increased at their 30-day visit by 5 mg to a maximum dose of 10 mg daily, if tolerated. If the participant does not tolerate the 10 mg dose, they will remain on 5 mg through the course o...
intervention 1: Donepezil
1
Jacksonville | Florida | United States | -81.65565 | 30.33218
33
0
0
0
NCT00805792
1COMPLETED
2010-09-01
2008-11-01
Mayo 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
[ 5 ]
110
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as no...
null
Polycystic Ovarian Syndrome Infertility
pre-menopausal women PCOS polycystic ovarian syndrome infertility IVF in vitro fertilization
null
4
arm 1: Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total durati...
[ 0, 0, 1, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days. intervention 2: 100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test. intervention 3: 225 IU (up to 450...
intervention 1: Menotropin intervention 2: Progesterone vaginal insert intervention 3: Follitropin beta intervention 4: Progesterone in oil intervention 5: leuprolide acetate
6
Littleton | Colorado | United States | -105.01665 | 39.61332 Clearwater | Florida | United States | -82.8001 | 27.96585 Chicago | Illinois | United States | -87.65005 | 41.85003 New York | New York | United States | -74.00597 | 40.71427 Providence | Rhode Island | United States | -71.41283 | 41.82399 Bedford | Texas | ...
110
0
0
0
NCT00805935
1COMPLETED
2010-09-01
2009-01-01
Ferring 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 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Octagam is a human normal immunoglobulin (IGIV) solution for intravenous administration. Octagam 5% is currently registered in more than 60 countries. This study will evaluate the efficacy, safety and the kinetics of Octagam 10% for replacement therapy in primary immunodeficiency diseases.
The primary objective of the study is to investigate the safety of Octagam 10% in replacement therapy in PID and to compare the pharmacokinetic profile of Octagam 10% with that of the previously used Octagam 5%. The secondary objective is to investigate the efficacy of Octagam 10% in replacement therapy in PID by moni...
Immunologic Deficiency Syndromes
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 300-600 mg/kg every 21 (+/- 3 days) to 28 days (+/- 3 days)
intervention 1: Octagam 10%
1
Vienna | N/A | Austria | 16.37208 | 48.20849
5
0
0
0
NCT00811174
6TERMINATED
2010-09-01
2009-01-01
Octapharma
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
4QUADRUPLE
false
0ALL
true
This study evaluated the effect of 6 or 12 infusions of different doses of octagam (intravenous immunoglobulin \[IVIG\]) 10% on the reduction of amyloid beta peptide (Aβ) in cerebral spinal fluid (CSF) and on the increase of Aβ in blood plasma in patients with mild to moderate Alzheimer's disease.
Participants received 12 infusions of 0.1 g/kg, 0.25 g/kg, or 0.4 g/kg body weight octagam 10% at 2-week intervals (±3 days) or 6 infusions of 0.2 g/kg, 0.5 g/kg, or 0.8 g/kg body weight octagam 10% at 4-week intervals (±5 days). The effect of the infusions on the reduction of Aβ peptide in CSF and the increase of Aβ p...
Alzheimer's Disease
null
8
arm 1: Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 2: Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions). arm 3: Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions)...
[ 2, 0, 0, 0, 2, 0, 0, 0 ]
2
[ 0, 2 ]
intervention 1: Commercially available 0.9% isotonic sodium chloride solution. intervention 2: octagam 10% was supplied as ready-to-use solutions of human immunoglobulin.
intervention 1: Placebo intervention 2: octagam 10%
1
Hoboken | New Jersey | United States | -74.03236 | 40.74399
56
0
0
0
NCT00812565
1COMPLETED
2010-09-01
2009-02-01
Octapharma
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 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this clinical experience study is to determine whether CC-5013 is safe and effective (to include studying the process by which a drug is absorbed, distributed, metabolized, and eliminated by the body \[pharmacokinetics\]) in Japanese subjects with low- or intermediate-1-risk MDS (IPSS risk categories) as...
null
Myelodysplastic Syndromes
Myelodysplastic Syndromes Lenalidomide
null
1
arm 1: Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
[ 0 ]
1
[ 0 ]
intervention 1: Oral 10mg daily on Days 1-21 days every 28 days until disease progression/relapse or CC-5013 is permanently discontinued for any reason for up to 156 weeks (3 years).
intervention 1: Lenalidomide
6
Shimono | Tochigi | Japan | N/A | N/A Shibuya-ku | Tokyo | Japan | N/A | N/A Hiroshima | N/A | Japan | 132.45 | 34.4 Kyoto | N/A | Japan | 135.75385 | 35.02107 Osaka | N/A | Japan | 135.50107 | 34.69379 Shizuoka | N/A | Japan | 138.38333 | 34.98333
11
0
0
0
NCT00812968
1COMPLETED
2010-09-01
2007-09-01
Celgene
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 ]
100
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to investigate whether low-dose simvastatin in combination with ezetimibe in comparison to high-dose simvastatin alone, has a beneficial effect on the function of the endothelium after an oral fat load in patients with metabolic syndrome.
Metabolic syndrome is defined as a group of cardiovascular risk factors and is mainly driven by the epidemic of obesity. High blood lipid levels after a meal may be an important risk factor for cardiovascular disease. In this study we will investigate whether simvastatin in combination with ezetimibe vs. simvastatin al...
Metabolic Syndrome
Postprandial hypertriglyceridemia Metabolic syndrome Endothelial function Flow mediated dilatation EndoPAT Simvastatin Ezetimibe
null
2
arm 1: First 6 weeks of Simvastatin 80mg, then 6 weeks of Simvastatin/Ezetimibe 10/10mg after 6 weeks of placebo washout arm 2: First 6 weeks of Simvastatin/Ezetimibe 10/10mg, then 6 weeks of Simvastatin 80mg after 6 weeks of placebo washout
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 6 weeks of treatment with simvastatin 80 mg intervention 2: 6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg combination
intervention 1: Simvastatin intervention 2: Simvastatin/Ezetimibe
5
Utrecht | Utrecht | Netherlands | 5.12222 | 52.09083 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403 Hoorn | N/A | Netherlands | 5.05972 | 52.6425 Waalwijk | N/A | Netherlands | 5.07083 | 51.6825 Lleida | N/A | Spain | 0.62218 | 41.61674
100
0
0
0
NCT00817843
1COMPLETED
2010-09-01
2009-04-01
dr.Frank L.J. Visseren
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 ]
308
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The present trial was set up to evaluate the efficacy and safety of 2.0 mg.kg-1 sugammadex compared to neostigmine administered at reappearance of T2 in Chinese and Caucasian subjects for registration purposes in China.
null
Anesthesia, General Neuromuscular Blockade
null
4
arm 1: At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered. arm 2: At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered. arm 3: At reappearance of T2 afte...
[ 0, 1, 0, 1 ]
2
[ 0, 0 ]
intervention 1: After induction of anesthesia an intubation dose of 0.6 mg/kg rocuronium was administered. Maintenance doses of 0.1-0.2 mg/kg rocuronium intravenous (IV) could be administered if necessary. At reappearance of T2 after the last administration of rocuronium, an IV single bolus dose of 2.0 mg/kg sugammadex...
intervention 1: Sugammadex intervention 2: neostigmine
0
null
291
0
0
0
NCT00825812
1COMPLETED
2010-09-01
2010-01-01
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 ]
55
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
1. To determine in a cross sectional case-controlled cohort study of 50 hemodialysis patients if blood pressure elevations with hemodialysis are associated with decreased endothelial cell function (measured by brachial artery flow mediated dilation and endothelial progenitor cell number), both of which are novel mechan...
null
Intradialytic Hypertension
Hypertension Hemodialysis
null
2
arm 1: Patients without intradialytic hypertension defined as average pre to post hemodialysis SBP falling \>10 mmhg for more than 4/6 of the last dialysis treatment sessions arm 2: Patients with intradialytic hypertension defined as average pre to post hemodialysis SBP elevation of \>10 mmhg for more than 4/6 of the l...
[ 4, 1 ]
1
[ 0 ]
intervention 1: Carvedilol 6.25 mg BID titrated weekly to maximum of 50 mg bid
intervention 1: Carvedilol
3
Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306 Dallas | Texas | United States | -96.80667 | 32.78306
50
0
0
0
NCT00827775
1COMPLETED
2010-09-01
2009-06-01
University of Texas Southwestern Medical Center
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 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
Ten adult patients age 19 and older with a clinical diagnosis of tinea versicolor, as well as a positive Potassium Hydroxide (KOH) using calcofluor. Ketoconazole 2% foam will be used to determine its effectiveness, safety and satisfaction when used to treat tinea versicolor.
Objectives 1. To assess the efficacy of ketoconazole 2% foam for the treatment of tinea versicolor 2. To assess the safety of ketoconazole 2% foam for the treatment of tinea versicolor based on the occurrence of adverse events. 3. To assess treatment satisfaction as rated by patients Study Design: This will be a mon...
Tinea Versicolor
tinea versicolor ketoconazole
null
1
arm 1: Open-label study
[ 0 ]
1
[ 0 ]
intervention 1: Ketoconazole 2% Foam, twice daily application to affected areas for 4 weeks.
intervention 1: Ketoconazole 2% Foam
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
11
0
0
0
NCT00830388
1COMPLETED
2010-09-01
2008-11-01
Boni Elewski, MD
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 ]
113
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the effectiveness and safety of an antiretroviral therapy (ART) regimen consisting of raltegravir (RAL) and darunavir (DRV)/ritonavir (RTV) as first-line therapy in treatment-naïve participants.
Despite the remarkable strides made in the treatment of HIV-1-infected persons over the last decade, current first-line ART regimens are imperfect. The ideal combination, unlike some current first-line options, would have uncompromised efficacy in the presence of transmitted drug-resistant variants. The primary purpose...
HIV-1 Infections
Treatment Naive
null
1
arm 1: Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
[ 0 ]
2
[ 0, 0 ]
intervention 1: 400 mg tablet taken orally twice daily intervention 2: 800 mg Darunavir/100 mg Ritonavir tablet taken orally once daily
intervention 1: Raltegravir intervention 2: Darunavir/Ritonavir
22
Birmingham | Alabama | United States | -86.80249 | 33.52066 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Aurora | Colorado | United States | -104.83192 | 39.72943 Washingto...
112
0
0
0
NCT00830804
1COMPLETED
2010-09-01
2009-04-01
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
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 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The study objective is to explore the safety and tolerability of STX209 in subjects with Autism Spectrum Disorders and to obtain preliminary data on several measures of efficacy in treating irritability. We hypothesize that STX209 will be safe and well-tolerated.
null
Autism Spectrum Disorders
Autism Autism Spectrum Disorders irritability aberrant behavior
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
intervention 1: Arbaclofen
8
Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 New Haven | Connecticut | United States | -72.92816 | 41.30815 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Nashv...
32
0
0
0
NCT00846547
1COMPLETED
2010-09-01
2009-02-01
Seaside Therapeutics, 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
[ 0 ]
49
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
Approximately 60 patients will be enrolled with highly suspected lung cancer, or head and neck cancer. The patients must also be starting radiotherapy or a chemoradiotherapy regimen (except with 5-fluorouracil). The patients will undergo 3 visits. One screening, one pre therapy PET/CT imaging visit, and one (3-5 weeks ...
PHASE: II/III OBJECTIVES: Primary: To investigate the clinical value of serial quantitative \[F-18\] FLT positron image assessment of tumor proliferation rates for early assessment of tumor response to radiation or chemoradiotherapy regimens (except with 5-fluorouracil) in comparison to serial quantitative \[F-18\] F...
Lung Cancer Head and Neck Cancer
lung cancer head and neck cancer radiotherapy chemoradiotherapy radiation chemoradiation FLT [F-18]FLT FDG [F-18]FDG
null
1
arm 1: Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate \[F-18\] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard \[F-18\] FDG PET will be the active comparator.
[ 0 ]
1
[ 0 ]
intervention 1: The individual doses of \[F-18\]FLT contain a maximum of 10 mCi. The single IP dose is administered to the study subject approximately 30 to 60 minutes prior to the start of PET imaging.
intervention 1: [F-18]FLT
2
Newport Beach | California | United States | -117.92895 | 33.61891 Houston | Texas | United States | -95.36327 | 29.76328
38
0
0
0
NCT00847509
1COMPLETED
2010-09-01
2009-02-01
Siemens Molecular Imaging
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 ]
410
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to provide further evidence of the clinical and bacteriological efficacy of retapamulin in the treatment of subjects with SITL or impetigo due to MRSA. Subjects aged 2 months and older will be treated with either topical retapamulin for 5 days or oral linezolid for 10 days. The primary endp...
This is a prospective, randomized, double-blind, double dummy, multicenter, comparative study in subjects 2 months of age and older with SITL (including secondarily-infected lacerations, sutured wounds and abrasions) or impetigo (bullous and non-bullous) due to MRSA. A laceration or sutured wound cannot exceed 10 cm in...
Skin Infections, Bacterial
impetigo methicillin-resistant Staphylococcus aureus linezolid secondarily-infected traumatic lesion uncomplicated skin infection retapamulin
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Topical retapamulin (SB-275833) ointment, 1% (w/w), and placebo ointment, will be provided as approximately 10 grams of an off-white smooth ointment in collapsible aluminum tubes with reverse-taper puncture-tip caps. Retapamulin or placebo ointment will be applied twice daily for 5 days. intervention 2:...
intervention 1: Retpamulin Ointment, 1% intervention 2: Linezolid
53
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Bentonville | Arkansas | United States | -94.20882 | 36.37285 Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Paragould | Arkansas | United States | -90.49733 | 36.0584 Bakerfield | Californi...
404
0
0
0
NCT00852540
1COMPLETED
2010-09-01
2009-04-01
Stiefel, a GSK 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
[ 2, 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
This multi-centre, non-randomized open phase I/randomized phase II study will be conducted in 70 patients (10 in phase I, 60 in phase II) with platinum-refractory recurrent epithelial cancer of the ovary, fallopian tube or peritoneum. A total of approximately 5 national centers will participate in phase I of the study....
null
Ovarian Cancer
ZD6474 Vandetanib Zactima Ovarian Cancer Phase I Phase II Randomized Safety
null
1
arm 1: Vandetanib added to standard therapy (pegliposomal doxorubicin)
[ 0 ]
1
[ 0 ]
intervention 1: 100mg doses orally, once daily
intervention 1: Vandetanib
5
Ulm | Baden-Wurttemberg | Germany | 9.99155 | 48.39841 Wiesbaden | Hesse | Germany | 8.24932 | 50.08258 Essen | North Rhine-Westphalia | Germany | 7.01228 | 51.45657 Kiel | Schleswig-Holstein | Germany | 10.13489 | 54.32133 Berlin | N/A | Germany | 13.41053 | 52.52437
14
0
0
0
NCT00862836
6TERMINATED
2010-09-01
2009-04-01
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
[ 0 ]
7
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical stero...
null
Transplant Intraocular Pressure
cornea transplant intraocular pressure steroid response
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: anterior juxtascleral depot of 15 mg anecortave acetate intervention 2: anterior juxtascleral depot of 30mg anecortave acetate
intervention 1: anecortave acetate intervention 2: 30 mg anecortave acetate
1
Indianapolis | Indiana | United States | -86.15804 | 39.76838
7
0
0
0
NCT00884039
6TERMINATED
2010-09-01
2009-05-01
Cornea Research Foundation of America
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 ]
30
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.
Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral med...
Anxiety Disorders HIV Infections
Escitalopram Anxiety Disorder HIV and AIDS treatment experienced
null
1
arm 1: Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being...
[ 0 ]
1
[ 0 ]
intervention 1: 10-20 mg/day oral of Escitalopram for 6-weeks. Escitalopram flexible dose (10-20 mg/day). A forced escalation schedule of escitalopram was used to titrate it to the maximum tolerated dose. Drug was discontinued at the end of the study.
intervention 1: Escitalopram
1
Durham | North Carolina | United States | -78.89862 | 35.99403
30
0
0
0
NCT00887679
1COMPLETED
2010-09-01
2009-05-01
Duke 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 ]
92
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
2MALE
false
The purpose of this study is to determine whether PRX302 is safe and effective in the treatment of moderate to severe Benign Prostatic Hyperplasia (BPH).
This is a randomized, double-blinded, placebo-controlled study of transperineal intraprostatic injection of PRX302 under sonographic guidance. Subjects will be randomly assigned to the two treatment groups in a ratio of 2:1 between PRX302 and Placebo, stratified by prostate size and baseline IPSS.
Benign Prostatic Hyperplasia
Benign Prostatic Hyperplasia BPH Enlarged Prostate
null
2
arm 1: PRX302 arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: PRX302 will be administered at a volume equivalent to 20% of the prostate volume and at a fixed concentration. Treatment will be administered through 1 injection into the transition zone of each lobe of the prostate. A minimum of 2 deposits will be made in the transition zone into each of the right and ...
intervention 1: PRX302 intervention 2: Placebo
9
Surrey | British Columbia | Canada | -122.82509 | 49.10635 Victoria | British Columbia | Canada | -123.35155 | 48.4359 Victoria | British Columbia | Canada | -123.35155 | 48.4359 Brampton | Ontario | Canada | -79.76633 | 43.68341 Brantford | Ontario | Canada | -80.26636 | 43.1334 Kitchener | Ontario | Canada | -80.5112...
92
0
0
0
NCT00889707
1COMPLETED
2010-09-01
2009-01-01
Sophiris Bio Corp
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 ]
100
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH\>300pg/mL) and that require dialysis at least 3 times per week.
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
Secondary Hyperparathyroidism Renal Insufficiency, Chronic Parathyroid Hormone Hemodialysis Hypercalcemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level.
intervention 1: Zemplar (paricalcitol)
3
Callao | N/A | Peru | -77.13452 | -12.05162 Lima | N/A | Peru | -77.02824 | -12.04318 Lima | N/A | Peru | -77.02824 | -12.04318
100
0
0
0
NCT00891813
1COMPLETED
2010-09-01
2009-05-01
Abbott
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
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
The purpose of this study was to determine the safety of AZX100 Drug Product and to determine whether it was effective in preventing or reducing re-growth of surgically removed keloid scars.
null
Scar Prevention Scar Reduction
AZX100 Patient and Observer Scar Assessment Scale POSAS Visual Analog Scale VAS Keloid Scarring Scar reduction Scar prevention
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Subjects were administered AZX100 0.3 mg per linear centimeter (low dose) intradermally at the site of the keloid scar removal. The first dose was given 19-23 days following surgery, and the second dose was given 40-44 days following surgery. intervention 2: Subjects were administered placebo (0.9% sali...
intervention 1: AZX100 Drug Product intervention 2: Placebo intervention 3: AZX100 Drug Product
3
Pasadena | California | United States | -118.14452 | 34.14778 Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Austin | Texas | United States | -97.74306 | 30.26715
59
0
0
0
NCT00892723
1COMPLETED
2010-09-01
2009-05-01
Capstone 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
[ 3 ]
208
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.
null
Rheumatoid Arthritis
null
4
arm 1: A low dose of LX3305; daily oral intake for 12 weeks arm 2: A mid dose of LX3305; daily oral intake for 12 weeks arm 3: A high dose of LX3305; daily oral intake for 12 weeks arm 4: Matching placebo dosing with daily oral intake for 12 weeks
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: A low dose of LX3305; daily oral intake for 12 weeks intervention 2: A mid dose of LX3305; daily oral intake for 12 weeks intervention 3: A high dose of LX3305; daily oral intake for 12 weeks intervention 4: Matching placebo dosing with daily oral intake for 12 weeks
intervention 1: LX3305 low dose intervention 2: LX3305 mid dose intervention 3: LX3305 high dose intervention 4: Placebo
38
Gainesville | Florida | United States | -82.32483 | 29.65163 Orange Park | Florida | United States | -81.70648 | 30.16607 Orlando | Florida | United States | -81.37924 | 28.53834 Tampa | Florida | United States | -82.45843 | 27.94752 Cumberland | Maryland | United States | -78.76252 | 39.65287 Hagerstown | Maryland | U...
208
0
0
0
NCT00903383
1COMPLETED
2010-09-01
2009-07-01
Lexicon 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
[ 2, 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This Phase 1/Phase 2 study will evaluate GMI-1070, a pan-selectin inhibitor, in adults with stable sickle cell disease. The study will assess safety, pharmacokinetics, and microvascular effects of intravenous GMI-1070 in the outpatient setting.
null
Sickle Cell Disease
Sickle Cell Disease
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Intravenous GMI-1070 given as two doses over the course of one day
intervention 1: GMI-1070
3
Oakland | California | United States | -122.2708 | 37.80437 Sacramento | California | United States | -121.4944 | 38.58157 Durham | North Carolina | United States | -78.89862 | 35.99403
15
0
0
0
NCT00911495
1COMPLETED
2010-09-01
2009-05-01
GlycoMimetics Incorporated
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
4QUADRUPLE
false
0ALL
false
The purpose of this study is to find out if bacterial load in the airways can be reduced after inhalation of ciprofloxacin for 28 days.
Safety issues are addressed in the AE section. There is no standardised and unanimously accepted definition of exacerbation in COPD; 4 definitions are widely used: (1) using a combination of 3 cardinal symptoms: increased dyspnea, sputum volume, and sputum purulence; (2) looking at the presence of the following pattern...
Bronchiectasis
Ciprofloxacin Airway infection Bronchiectasis
null
2
arm 1: 32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily arm 2: Inhalation of matching placebo twice a day
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Inhalation of 32,5mg Ciprofloxacin inhaled twice a day intervention 2: Inhalation of matching placebo twice a day
intervention 1: Ciprofloxacin (Cipro, BAYQ3939) intervention 2: Placebo
47
Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California | United States | -117.2742 | 32.84727 Denver | Colorado | United States | -104.9847 | 39.73915 Farmington | Connecticut | United States | -72.83204 | 41.71982 Washington D.C. | District of Columbia | United States | -77.03637 | 38.8951...
124
0
0
0
NCT00930982
1COMPLETED
2010-09-01
2009-06-01
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
[ 5 ]
13
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the usefulness of antifungal lock therapy with liposomal amphotericin B (Ambisome), in combination with systemic antifungal(s), in patients with catheter-related blood stream infections with fungal organisms, whose catheter has not been removed because of the continuing critical...
This is a descriptive study in intestinal failure patients with catheter-related blood stream infections (CRBSI) with fungal organisms. At present, the recommendation of the Infectious Disease Society of America (IDSA) is to remove all catheters with fungal infections and treat systemically for 14 days after the last p...
Central Line Fungal Infections
central line fungal infections antifungal lock therapy Ambisome lock therapy
null
1
arm 1: Intestinal failure and other patients with poor IV access and central line fungal-related infections will receive intravenous systemic antifungal therapy plus the instillation of Ambisome locks into the infected catheter.
[ 0 ]
1
[ 0 ]
intervention 1: After enrollment, antifungal therapy will be instituted consisting of both systemic and antifungal lock therapy. Systemic therapy will be amphotericin B liposomal (Ambisome) administered IV in a dose of 3-5 mg/kg/day (or other antifungal based upon standard of care) combined with antifungal lock therapy...
intervention 1: amphotericin B liposomal (Ambisome)
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
13
0
0
0
NCT00936910
1COMPLETED
2010-09-01
2006-09-01
Bill McGhee
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 ]
54
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
The purpose of this study is to determine pharmacokinetics, safety and efficacy of Magnevist in children 2 months to \< 2 years of age
Safety issues are addressed in the AE section
Magnetic Resonance Imaging
MRI agents Magnevist
null
1
arm 1: For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received the optimal...
[ 0 ]
1
[ 0 ]
intervention 1: For stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For stage 2: Participants received th...
intervention 1: Gadopentetate dimeglumine (Magnevist, BAY86-6661)
13
San Diego | California | United States | -117.16472 | 32.71571 Aurora | Colorado | United States | -104.83192 | 39.72943 Chicago | Illinois | United States | -87.65005 | 41.85003 Iowa City | Iowa | United States | -91.53017 | 41.66113 Kansas City | Missouri | United States | -94.57857 | 39.09973 St Louis | Missouri | U...
54
0
0
0
NCT00937391
1COMPLETED
2010-09-01
2010-01-01
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
[ 4 ]
805
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).
null
Irritable Bowel Syndrome With Constipation
IBS
null
2
arm 1: None arm 2: None
[ 2, 0 ]
1
[ 0 ]
intervention 1: Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
intervention 1: Linaclotide or Matching Placebo
107
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tempe | Arizona | United States | -111.90931 | 33.41477 Tucson | Arizona | United States | -110.92648 | 32.22174 Tucson | Arizona | United Stat...
805
0
0
0
NCT00938717
1COMPLETED
2010-09-01
2009-07-01
Ironwood Pharmaceuticals, 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 ]
198
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12.
The study evaluated the efficacy of AMG 827 compared with placebo as measured by the percent of improvement in PASI score at week 12. Subjects were randomized ina 1:1:1:1:1 ratio. Subjects randomized to receive AMG 827 received 70, 140, or 210 mg at day 1 and weeks 4 and 8.
Psoriasis
null
5
arm 1: 140 mg SC arm 2: 70 mg SC arm 3: 280 mg SC arm 4: 210 mg SC arm 5: Placebo
[ 0, 0, 0, 2, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: 70 mg SC intervention 2: 210 mg SC intervention 3: 140 mg SC intervention 4: 280 mg SC intervention 5: Placebo SC
intervention 1: 70 mg SC intervention 2: 210 mg SC intervention 3: 140 mg SC intervention 4: 280 mg SC intervention 5: Placebo
0
null
198
0
0
0
NCT00975637
1COMPLETED
2010-09-01
2009-12-01
Bausch Health Americas, 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 ]
224
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The main objective of the study is to evaluate the effectiveness, tolerability, and safety of tapentadol hydrochloride prolonged release in participants suffering from severe chronic pain due to osteoarthritis of the knee who are taking either WHO Step I or Step II analgesics or no regular analgesics. This is a clinica...
null
Chronic Pain Osteoarthritis
Osteoarthritis Pain Assessment Tapentadol Centrally acting analgesic Chronic pain due to osteoarthritis
null
1
arm 1: Tapentadol PR was given orally twice a day. A maximum of 2 oral Tapentadol IR tablets per day, with a minimum of a 4 hour interval between doses, were taken if there were acute pain episodes. The total daily dose of Tapentadol PR and IR were not permitted to exceed 500 mg per day.
[ 0 ]
1
[ 0 ]
intervention 1: Tapentadol Prolonged Release (PR) Titration and Optimal Dose Period: Starting at 50 mg Tapentadol PR twice daily, adjusting at 50 mg PR steps (upwards or downwards) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. Participants were not permitted to exceed 5...
intervention 1: Tapentadol
24
Belfort | N/A | France | 6.85385 | 47.64218 Marseille | N/A | France | 5.38107 | 43.29695 Murs Erigné | N/A | France | N/A | N/A Nantes | N/A | France | -1.55336 | 47.21725 Berlin | N/A | Germany | 13.41053 | 52.52437 Köln Dünnwald | N/A | Germany | N/A | N/A Leipzig | N/A | Germany | 12.37129 | 51.33962 Leipzig | N/A ...
200
0
0
0
NCT00983073
1COMPLETED
2010-09-01
2009-09-01
Grünenthal GmbH
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 ]
82
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
null
Dry Eye Syndromes Keratoconjunctivitis Sicca
null
2
arm 1: carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD) arm 2: sodium hyaluronate 0.18% (VISMED® Multi)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: One drop in each eye three to six times daily, as needed intervention 2: One drop in each eye three to six times daily, as needed
intervention 1: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) intervention 2: sodium hyaluronate 0.18% (VISMED® Multi)
1
Paris | N/A | France | 2.3488 | 48.85341
79
0
0
0
NCT00987727
1COMPLETED
2010-09-01
2009-11-01
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
[ 4 ]
46
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
true
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA.
This was a randomized, active-controlled, double-blind, cross-over study designed to enroll subjects with UCDs who are being treated with NaPBA. Subjects were randomly assigned to receive either HPN-100 + NaPBA placebo or NaPBA + HPN 100 placebo for 2 weeks, and then crossed over to receive the other treatment for 2 we...
Urea Cycle Disorders
Urea Cycle Disorder (UCD) UCD hyperammonemia Buphenyl (NaPBA) glycerol phenylbutyrate (GPB) Sodium Phenylbutyrate (NaPBA)
null
2
arm 1: Subjects in Arm A were randomly assigned to receive NaPBA + HPN 100 placebo for 2 weeks and then crossed over to receive HPN 100 + NaPBA Placebo for 2 weeks. arm 2: Subjects in Arm B were randomly assigned to receive HPN-100 + NaPBA placebo for 2 weeks and then crossed over to receive NaPBA + HPN 100 placebo for...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (\~17.4mL) delivers equivalent amount of PBA in 40 tablets of NaPBA. intervention 2: Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.
intervention 1: HPN-100 intervention 2: Buphenyl (NaPBA)
22
Long Beach | California | United States | -118.18923 | 33.76696 Los Angeles | California | United States | -118.24368 | 34.05223 Stanford | California | United States | -122.16608 | 37.42411 Aurora | Colorado | United States | -104.83192 | 39.72943 New Haven | Connecticut | United States | -72.92816 | 41.30815 Washingt...
89
0
0
0
NCT00992459
1COMPLETED
2010-09-01
2009-10-01
Amgen
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, 4 ]
31
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
true
0ALL
true
The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract in treating nail psoriasis.
Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis remains unverified.
Nail Psoriasis
Nail psoriasis Indigo naturalis
null
2
arm 1: Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks. arm 2: Olive oil was applied to the fingernails of the contra-lateral hand (c...
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks intervention 2: Olive oil was applied to the fingernails of the contr...
intervention 1: Indigo Naturalis Extract in Oil intervention 2: Olive Oil
0
null
31
0
0
0
NCT00999687
1COMPLETED
2010-09-01
2009-09-01
Chang Gung Memorial Hospital
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 ]
687
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Africa, Asia, Europe and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec (IDeg) with insulin glargine (IGlar) in patients with type 2 diabetes. Subjects treated with oral antidiabetic drug(s) (OAD(s)) should continue their current OAD treatment at the stab...
null
Diabetes Diabetes Mellitus, Type 2
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Injected s.c. (under the skin) once daily (alternative regimen). Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily. Dose was individually adjusted. intervention 3: Insulin glargine injected s.c. (under the skin) once daily. Dose was individually adjusted.
intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin glargine
72
Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Buenos Aires | N/A | Argentina | -58.37723 | -34.61315 Ciudad Autónoma de Bs As | N/A | Argentina | N/A | N/A Rosario | N/A | Argentina | -60.63932 | -32.94682 Hanko | N/A | Finland | 22.95 | 59.83333 Harjavalta | N/A | Finland | 22.13333 | 61.31667 Oulu | N/A | Fi...
685
0
0
0
NCT01006291
1COMPLETED
2010-09-01
2009-11-01
Novo Nordisk A/S
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 ]
491
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The objective of the study is to investigate the efficacy and safety of linagliptin 2.5 mg twice daily compared to 5 mg once daily compared to placebo given orally for 12 weeks as add-on therapy to metformin in patients with type 2 diabetes mellitus with insufficient glycaemic control. It is planned to show non-inferio...
null
Diabetes Mellitus, Type 2
null
3
arm 1: linagliptin low dose twice daily arm 2: placebo matching linagliptin arm 3: linagliptin medium dose once daily
[ 0, 2, 0 ]
3
[ 0, 0, 0 ]
intervention 1: patient to receive tablets containing low dose linagliptin twice daily intervention 2: patient to receive placebo tablet(s) matching linagliptin intervention 3: patient to receive a tablet containing medium dose linagliptin once daily
intervention 1: linagliptin low dose intervention 2: placebo intervention 3: linagliptin medium dose
84
De Pinte | N/A | Belgium | 3.64747 | 50.99339 Kortenaken | N/A | Belgium | 5.05968 | 50.90862 Kumtich | N/A | Belgium | 4.88723 | 50.82101 Massemen-Wetteren | N/A | Belgium | N/A | N/A Natoye | N/A | Belgium | 5.058 | 50.34294 Sint-Job-in't-Goor | N/A | Belgium | N/A | N/A Tessenderlo | N/A | Belgium | 5.08856 | 51.065...
491
0
0
0
NCT01012037
1COMPLETED
2010-09-01
2009-11-01
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
0
0
0
0
0
0
0
0
-0
[ 3 ]
51
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to identify at least 1 dose of daclatasvir that is safe, well tolerated, and efficacious when combined with peginterferon-alfa and ribavirin for the treatment of hepatitis C virus genotype 1 in chronically infected patients who are treatment-naïve and nonresponsive to the standard of care
null
Hepatitis C Infection
null
5
arm 1: Treatment Naive arm 2: Treatment Naive arm 3: Treatment Naive arm 4: Non-Responder arm 5: Non-Responder
[ 0, 0, 2, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Tablets, Oral, 10 mg, daily, 24-48 weeks intervention 2: Tablets, Oral, 60 mg, daily, 24-48 weeks intervention 3: Tablets, Oral, 0 mg, daily, 48 weeks intervention 4: Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks intervention 5: Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
intervention 1: BMS-790052 intervention 2: BMS-790052 intervention 3: Placebo intervention 4: Peginterferon alfa-2b intervention 5: Ribavirin
6
Hiroshima | Hiroshima | Japan | 132.45 | 34.4 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Kawasaki-Shi | Kanagawa | Japan | N/A | N/A Suita-Shi | Osaka | Japan | N/A | N/A Iruma-Gun | Saitama | Japan | N/A | N/A Minato-Ku | Tokyo | Japan | N/A | N/A
45
0
0
0
NCT01016912
1COMPLETED
2010-09-01
2009-12-01
Bristol-Myers Squibb
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 ]
383
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284 compared with placebo in patients with type 2 diabetes.
Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. Various classes of orally administered antihyperglycemic agents have been developed for the treatment of ...
Type 2 Diabetes Mellitus
TA-7284 JNJ-28431754 Canagliflozin Type 2 diabetes mellitus Sodium Glucose Co-transporter (SGLT2 inhibitor)
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo
intervention 1: TA-7284-Low intervention 2: TA-7284-Low-middle intervention 3: TA-7284-High-middle intervention 4: TA-7284-High intervention 5: Placebo
6
Chugoku | N/A | Japan | N/A | N/A Kanto | N/A | Japan | N/A | N/A Kinki | N/A | Japan | N/A | N/A Kyushu | N/A | Japan | N/A | N/A Shikoku | N/A | Japan | N/A | N/A Tōhoku | N/A | Japan | 139.57138 | 35.81882
383
0
0
0
NCT01022112
1COMPLETED
2010-09-01
2009-11-01
Mitsubishi Tanabe Pharma Corporation
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 ]
40
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
It is been known for at least 20 years that the hemodynamic data, the amount of exercise performed as well as symptoms on the treadmill, has significant value to the perfusion stress testing. When a pharmacologic stress test is performed (and adenosine stress test over 4-6 minutes), this hemodynamic data is lost. Becau...
A nuclear stress test has been recommended for a patient by their doctor. This test helps to detect significant blockages in the artery to the heart. The test involves the patient walking on a treadmill until their heart rate reaches 85% of their age-determined maximal predicted heart rate. If the patient needs to stop...
Cardiac Function
Regadenoson 85% predicted heart rate Myocardial perfusion stress testing
null
1
arm 1: patient with submaximal symptom limited maximal exercise testing will also be administered regadenoson pharmacological stress test.
[ 0 ]
1
[ 0 ]
intervention 1: Regadenoson dose of 400 mcg will be infused over 10-20 seconds followed by a saline flush.
intervention 1: regadenoson
1
Westminster | Maryland | United States | -76.99581 | 39.57538
40
0
0
0
NCT01026012
1COMPLETED
2010-09-01
2009-12-01
University of Maryland, Baltimore
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 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.
null
Skin and Soft Tissue Infections
outpatient skin and soft tissue infections vancomycin intravenous
null
2
arm 1: Subject receives vancomycin 30 mg/kg dose arm 2: Subject receives vancomycin 15 mg/kg twice daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: vancomycin 30 mg/kg intravenous administered once daily intervention 2: vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)
intervention 1: vancomycin intervention 2: vancomycin
1
New Westminster | British Columbia | Canada | -122.91092 | 49.20678
8
0
0
0
NCT01037192
1COMPLETED
2010-09-01
2010-03-01
Fraser Health
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 ]
120
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
1FEMALE
false
Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction . The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as pat...
Sore throat is a common postoperative complaint that can lead to morbidity and patient dissatisfaction. The incidence of sore throat has been reported to be between 6% and 90% even under optimal intubating conditions. There are several factors that have been shown to contribute to postoperative sore throat such as pati...
Sore Throat Pain
Sore throat Dexamethasone Pain
null
3
arm 1: Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery. arm 2: Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery arm 3: Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
[ 2, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo administration intervention 2: Dexamethasone 0.05mg/kr administered in 100ml of sterile saline solution prior to the start of surgery. intervention 3: Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to the beginning of surgery.
intervention 1: Placebo administration intervention 2: Dexamethasone 0.05mg/kr administration intervention 3: Dexamethasone 0.1mg/kg
1
Chicago | Illinois | United States | -87.65005 | 41.85003
120
0
0
0
NCT01052038
1COMPLETED
2010-09-01
2010-01-01
Northwestern 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 ]
235
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study will evaluate the safety and efficacy of once daily administered 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution compared with once daily administered 0.03% Bimatoprost Ophthalmic Solution and once daily administered 0.5% Timolol Ophthalmic Solution concurrently in patients with open-angle glaucoma or ocu...
null
Open-angle Glaucoma Ocular Hypertension
null
2
arm 1: Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution arm 2: Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution intervention 2: One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophth...
intervention 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution intervention 2: 0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution
1
Beijing | N/A | China | 116.39723 | 39.9075
235
0
0
0
NCT01068964
1COMPLETED
2010-09-01
2010-02-01
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
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study was to assess efficacy and safety of fixed dose combination of 5 mg amlodipine/80 mg valsartan compared to 160 mg valsartan monotherapy in lowering blood pressure in Taiwanese patients.
null
Hypertension High Blood Pressure
Hypertension valsartan amlodipine high blood pressure
null
3
arm 1: During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks. arm 2: In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks. arm 3: D...
[ 0, 1, 5 ]
2
[ 0, 0 ]
intervention 1: Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks. intervention 2: For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks. Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) da...
intervention 1: Amlodipine 5mg/Valsartan 80 mg intervention 2: Valsartan
1
Taipei | N/A | Taiwan | 121.52639 | 25.05306
42
0
0
0
NCT01070043
1COMPLETED
2010-09-01
2009-06-01
Novartis
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 ]
176
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this multicenter, dose-ranging study is to compare two Fixed-Dose Combinations of aclidinium bromide and formoterol fumarate with placebo, aclidinium bromide and formoterol fumarate, all administered BID in patients with stable, moderate to severe COPD. Every treatment period is 14-days long and there i...
null
Chronic Obstructive Pulmonary Disease
Bronchitis Chronic Emphysema
null
5
arm 1: Formoterol fumarate 12 μg twice daily arm 2: Placebo twice daily arm 3: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily arm 4: Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily arm 5: Aclidinium bromide 200 μg twice daily
[ 1, 2, 0, 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily intervention 2: Placebo control twice daily intervention 3: Formoterol fumarate 12 μg twice daily intervention 4: Aclidinium bromide 200 μg twice daily intervention 5: Aclidinium bromide 200 μg + formoterol fu...
intervention 1: Aclidinium 200 μg / formoterol 12 μg intervention 2: Placebo intervention 3: Formoterol 12 μg intervention 4: Aclidinium 200 μg intervention 5: Aclidinium 200 μg / Formoterol 6 μg
10
Bucuresti | N/A | Czechia | N/A | N/A Constanta | N/A | Czechia | N/A | N/A Iasi | N/A | Czechia | N/A | N/A Tg Mures | N/A | Czechia | N/A | N/A Bucharest | N/A | Romania | 26.10626 | 44.43225 Cluj-Napoca | N/A | Romania | 23.6 | 46.76667 Deva | N/A | Romania | 22.9 | 45.88333 Iași | N/A | Romania | 27.6 | 47.16667 Or...
505
0
0
0
NCT01078623
1COMPLETED
2010-09-01
2010-02-01
AstraZeneca
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 ]
89
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This is multi-center, randomized, placebo-controlled, parallel-group, double-blind, dose-escalating clinical trial designed to assess the efficacy and safety of desmopressin orally lyophilisate for the treatment of nocturnal enuresis "with decreased nighttime urinary osmolality."
null
Nocturnal Enuresis
null
2
arm 1: During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment f...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime. intervention 2: Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
intervention 1: Desmopressin intervention 2: Placebo
15
Akita | Akita | Japan | 140.11667 | 39.71667 Hiroshima | Hiroshima | Japan | 132.45 | 34.4 Amagasaki | Hyōgo | Japan | 135.41667 | 34.71667 Kakogawa | Hyōgo | Japan | 134.82905 | 34.76943 Mito | Ibaraki | Japan | 140.45 | 36.35 Yokohama | Kanagawa | Japan | 139.65 | 35.43333 Niigata | Niigata | Japan | 139.04125 | 37.9...
89
0
0
0
NCT01078753
1COMPLETED
2010-09-01
2010-01-01
Ferring 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
[ 2, 3 ]
100
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
1FEMALE
true
Intravenous Tranexamic acid is used to reduce the hemorrhage during and after cesarean delivery in a double blind randomized placebo controlled trial.
null
Hemorrhage
cesarean delivery Tranexamic acid hemorrhage Spinal analgesia 1-the amount of hemorrhage during cesarean delivery 2-the amount of hemorrhage in the first 2 hours of cesarean delivery 3-the amount of hemorrhage in the first 24 hour after cesarean delivery
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tranexamic acid in cases, normal saline in controls intervention 2: Tranexamic acid in cases, normal saline in controls
intervention 1: Tranexamic acid intervention 2: Normal saline
1
Tehran | N/A | Iran | 51.42151 | 35.69439
100
0
0
0
NCT01085006
1COMPLETED
2010-09-01
2009-09-01
Tehran University of Medical Sciences
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 ]
185
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to assess the effect of six weeks' treatment with two once-daily strengths of Fluticasone Furoate/GW642444 Inhalation Powder on the HPA axis system
null
Asthma
HPA axis
null
4
arm 1: Fluticasone furoate/GW642444 Dose B inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the study arm 2: Fluticasone furoate/GW642444 Dose A inhalation powder once daily for 6 weeks' treatment + 1 oral placebo capsule each day on the last 7 days of the stud...
[ 1, 1, 2, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Placebo Inhalation powder inhaled once daily for 6 weeks' treatment intervention 2: Dose B inhaled once daily for 6 weeks' treatment intervention 3: Dose A inhaled once daily for 6 weeks' treatment intervention 4: One placebo capsule taken each day on the last 7 days of the study intervention 5: Prednis...
intervention 1: Placebo Inhalation Powder intervention 2: Fluticasone Furoate/GW642444 Inhalation Powder intervention 3: Fluticasone Furoate/GW642444 Inhalation Powder intervention 4: Placebo Oral Capsule intervention 5: Prednisolone Oral Capsule
17
Cypress | California | United States | -118.03729 | 33.81696 Huntington Beach | California | United States | -117.99923 | 33.6603 Oklahoma City | Oklahoma | United States | -97.51643 | 35.46756 San Antonio | Texas | United States | -98.49363 | 29.42412 Hamburg | City state of Hamburg | Germany | 9.99302 | 53.55073 Fran...
185
0
0
0
NCT01086410
1COMPLETED
2010-09-01
2010-03-01
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
[ 2 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
The study will evaluate the pharmacokinetics of testosterone transdermal systems at steady-state in hypogonadal men.
Subjects will receive testosterone for 4 weeks. Based on a single morning testosterone measurement performed at the end of Week 1, the dosage can be titrated up or down to the next dose level to maintain testosterone levels in the normal range. At the end of 4 weeks of treatment, a pharmacokinetic profile for total tes...
Hypogonadism
Hypogonadism Testosterone Hormone replacement therapy
null
1
arm 1: Testosterone
[ 0 ]
1
[ 0 ]
intervention 1: Transdermal testosterone applied daily for 4 weeks
intervention 1: Testerone Transdermal System
3
Miramar | Florida | United States | -80.23227 | 25.98731 Omaha | Nebraska | United States | -95.94043 | 41.25626 San Antonio | Texas | United States | -98.49363 | 29.42412
40
0
0
0
NCT01104246
1COMPLETED
2010-09-01
2010-04-01
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
[ 2 ]
26
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to assess whether eribulin mesylate (E7389) has an impact on the electrocardiogram (ECG) with focus on cardiac repolarization, as measured by QT/QTc interval as well as through a pharmacokinetic-pharmacodynamic (PK/PD) analysis.
This is an open-label, multicenter, single arm QT Interval prolongation study of eribulin mesylate (E7389) in patients with advanced solid tumors.
Advanced Solid Tumor
tumor
null
1
arm 1: None
[ 5 ]
1
[ 0 ]
intervention 1: 1.4 mg/m\^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
intervention 1: Eribulin Mesylate
2
Dunkirk | *CS | France | 2.37681 | 51.0344 Dunkirk | *CS | France | 2.37681 | 51.0344
26
0
0
0
NCT01106248
1COMPLETED
2010-09-01
2009-03-01
Eisai Limited
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 ]
40
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
true
0ALL
false
A study in healthy volunteers of the next morning driving performance after middle-of-the-night dosing of 3.5 mg zolpidem tartrate sublingual tablet, a sleep aid. The next morning driving performance will be measured by taking a standardized driving test.
null
Insomnia
insomnia
null
4
arm 1: Zopiclone is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet. arm 2: A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving. arm...
[ 1, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing. intervention 2: 3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allo...
intervention 1: zopiclone intervention 2: zolpidem tartrate sublingual tablet intervention 3: Placebo (sublingual tablet) intervention 4: Placebo
1
Maastricht | N/A | Netherlands | 5.68889 | 50.84833
160
0
0
0
NCT01106859
1COMPLETED
2010-09-01
2010-06-01
Transcept 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 ]
180
RANDOMIZED
PARALLEL
2DIAGNOSTIC
2DOUBLE
false
0ALL
false
The purpose of this study was to evaluate the efficacy of Maxidex and Patanol compared to placebo in patients with allergic conjunctivitis when exposed to controlled allergen levels in an Environmental Exposure Chamber (EEC).
This study consisted of 6 visits. Visit 1 was the Medical Screening Visit (skin prick test). Visit 2 and Visit 3 consisted of 2 consecutive EEC Visits (3 hours in the EEC followed by 7 hours in the Clinic, 10 hours total, each visit) followed by 7 days of wash-out. Visit 2 and Visit 3 occurred prior to dispense and the...
Allergic Conjunctivitis
Conjunctivitis ocular allergy
null
3
arm 1: Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] arm 2: Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days \[Visit 4 through Visit 6 morning only\] ar...
[ 0, 0, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Maxidex intervention 2: Patanol intervention 3: Tears Naturale II
intervention 1: Dexamethasone 0.1% ophthalmic suspension intervention 2: Olopatadine hydrochloride 0.1% ophthalmic solution intervention 3: Inactive ingredients, used as placebo
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
170
0
0
0
NCT01119287
1COMPLETED
2010-09-01
2010-03-01
Alcon Research
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 ]
16
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
true
1FEMALE
false
This study is a primary investigation to determine the usefulness and safety of a short course of a relatively high dose of letrozole (a medication used to decrease the female hormone estrogen which is produced locally inside the breast after menopause) in improving the performance of of breast MRI (Magnetic Resonance ...
A breast MRI will be performed in the standard way for diagnosis and to serve as a baseline. A second MRI will be performed within a month and following administration of letrozole 12.5 mg daily for three days to reduce breast estrogen levels and in anticipation of lowering breast gadolinium dye uptake.
Breast Cancer
Letrozole Breast MRI Postmenopausal women
null
1
arm 1: Single arm of healthy postmenopausal women who received baseline diagnostic MRI will receive letrozole of 12.5 mg/day orally for three successive days. A second post treatment breast MRI is done right after receiving the three days of letrozole treatment and within one month after the first MRI .
[ 0 ]
1
[ 0 ]
intervention 1: Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
intervention 1: letrozole
1
Toronto | Ontario | Canada | -79.39864 | 43.70643
14
0
0
0
NCT01129622
1COMPLETED
2010-09-01
2008-10-01
Mount Sinai Hospital, Canada
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 ]
63
NA
SINGLE_GROUP
1PREVENTION
0NONE
false
0ALL
false
The purpose of this study was to evaluate the feasibility of individualized titration of patiromer according to serum potassium. This study also assessed the safety and tolerability of patiromer and the effects of patiromer on serum potassium in heart failure (HF) participants with chronic kidney disease (CKD).
This was an open-label, single-arm study to evaluate a titration regimen for patiromer in approximately 63 HF participants with CKD receiving one or more of the following: angiotensin-converting enzyme inhibitors (ACEIs), angiotensin II receptor blockers (ARBs), or beta blockers (BBs). This study was considered to be e...
Heart Failure
HF Heart failure hyperkalemia chronic kidney disease prevention of hyperkalemia in heart failure participants
null
1
arm 1: spironolactone + patiromer
[ 0 ]
2
[ 0, 0 ]
intervention 1: Active investigational drug intervention 2: None
intervention 1: patiromer intervention 2: spironolactone
13
Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.69143 Tbilisi | N/A | Georgia | 44.83412 | 41.6914...
63
0
0
0
NCT01130597
1COMPLETED
2010-09-01
2010-05-01
Relypsa, 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 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of the study is to evaluate the effects of BDP HFA Nasal Aerosol on HPA-axis function.
null
Perennial Allergic Rhinitis
null
3
arm 1: Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone. arm 2: Participants self-administered 4 actuatio...
[ 2, 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo nasal aerosol administered daily for 42 days of treatment intervention 2: Prednisone 10 mg capsule taken each day on the last 7 days of treatment intervention 3: Placebo prednisone capsule taken each day on the last 7 days of treatment intervention 4: Total daily dose of 320 micrograms per day o...
intervention 1: Placebo Nasal Aerosol intervention 2: Prednisone capsules intervention 3: Placebo Prednisone Capsules intervention 4: Beclomethasone dipropionate
3
North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 New Braunfels | Texas | United States | -98.12445 | 29.703 San Antonio | Texas | United States | -98.49363 | 29.42412
107
0
0
0
NCT01133626
1COMPLETED
2010-09-01
2010-06-01
Teva Branded Pharmaceutical Products R&D, 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 ]
15
NON_RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the single dose pharmacokinetics of crizotinib in healthy volunteers.
null
Healthy
crizotinib healthy volunteers ketoconazole pharmacokinetics single dose
null
1
arm 1: There should be at least 14-day washout period between treatment A and B.
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets. intervention 2: Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from...
intervention 1: crizotinib intervention 2: ketoconazole intervention 3: crizotinib
1
South Miami | Florida | United States | -80.29338 | 25.7076
30
0
0
0
NCT01149785
1COMPLETED
2010-09-01
2010-07-01
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 ]
20
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
3TRIPLE
true
2MALE
false
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.
A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.
Reflux
Pharmacodynamic effect Reflux inhibition
null
4
arm 1: period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. arm 2: period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. arm 3:...
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Capsule, oral intervention 2: Capsule, oral intervention 3: Capsule, oral intervention 4: Capsule, oral
intervention 1: AZD2516, 5 mg intervention 2: AZD2516, 16 mg intervention 3: AZD2516, 40 mg intervention 4: Placebo
2
Leuven | N/A | Belgium | 4.70093 | 50.87959 Amsterdam | N/A | Netherlands | 4.88969 | 52.37403
80
0
0
0
NCT01154634
1COMPLETED
2010-09-01
2010-05-01
AstraZeneca
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 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
The primary objective of the study is to determine any drug interaction between the antimalarial Pyramax (pyronaridine artesunate) and the protease inhibitor ritonavir in healthy subjects. The secondary objective of the study is to assess further the safety of Pyramax in this setting.
This is a phase I, open label, randomized study to determine any drug interaction between Pyramax (pyronaridine/artesunate) and the protease inhibitor ritonavir in healthy volunteers. A total of 34 healthy volunteers (17 per treatment arm) will be enrolled in the study so that at least 30 (15 per treatment arm) will co...
Malaria
malaria artemisinin-based combination therapy (ACT) antimalarial pyronaridine artesunate (Pyramax)
null
2
arm 1: 7 days of ritonavir followed by 3 days of ritonavir plus Pyramax followed by 7 days of ritonavir followed by a 33 day follow-up period (40 days since last Pyramax dosing) and a study completion evaluation. arm 2: 3 day treatment course of Pyramax, followed by a follow up period of 40 days since last Pyramax dosi...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 100 mg ritonavir (one soft gelatin capsule twice per day over 17 days, the evening capsule on day 1 will be omitted) and Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets once per day according to weight for 3 days). intervention 2: Pyramax (pyronaridine/artesunate) 180:60 mg (3 to 4 tablets o...
intervention 1: Ritonavir and Pyramax intervention 2: Pyramax
1
Allschwil | Basel | Switzerland | 7.53599 | 47.55074
34
0
0
0
NCT01156389
1COMPLETED
2010-09-01
2010-07-01
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
[ 4 ]
30
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
0NONE
false
0ALL
true
Metabolic defects contributing to the development of type 2 diabetes (T2D) are relative insulin insufficiency and insulin resistance that are associated with a cluster of abnormalities that increase the risk for cardiovascular disease including dyslipidemia, inflammation, hemodynamic changes and endothelial dysfunction...
Thiazolidinediones (TZDs) are pharmacological ligands for the nuclear receptor peroxisome-proliferator-activated receptor gamma (PPAR-γ). When activated, the receptor binds with response elements on DNA, altering transcription of a variety of genes that regulate carbohydrate and lipid metabolism1. The hypoglycemic and ...
Type 2 Diabetes Mellitus
diabetes dyslipidemia pioglitazone HDL-Cholesterol Reverse cholesterol transport
null
2
arm 1: This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level arm 2: This group of subjects will be maintained on standard treatment with either metformin o...
[ 1, 4 ]
1
[ 0 ]
intervention 1: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
intervention 1: pioglitazone
1
Miami | Florida | United States | -80.19366 | 25.77427
30
0
0
0
NCT01156597
1COMPLETED
2010-09-01
2008-04-01
University of Miami
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 ]
20
RANDOMIZED
CROSSOVER
null
4QUADRUPLE
true
0ALL
false
The study is designed to evaluate elements of cognitive function in subjects receiving either fesoterodine or alprazolam.
Evaluation of cognitive function
Healthy
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 4mg tablet once daily for 6 days intervention 2: 4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days intervention 3: 1mg tablet once on last day of treatment period at clinic intervention 4: Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam...
intervention 1: 4mg fesoterodine intervention 2: 8mg fesoterodine intervention 3: alprazolam 1mg intervention 4: Placebo
2
Overland Park | Kansas | United States | -94.67079 | 38.98223 Overland Park | Kansas | United States | -94.67079 | 38.98223
78
0
0
0
NCT01161472
1COMPLETED
2010-09-01
2010-07-01
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
[ 2 ]
14
RANDOMIZED
PARALLEL
null
0NONE
true
0ALL
false
This study will be an open-label, randomized, 2-period, 2-treatment, 2-sequence, cross-over single-dose study to test the absolute bioavailability of oral crizotinib formulation to IV formulation in healthy adult volunteers. Fourteen (14) subjects will be enrolled to obtain at least 12 evaluable subjects who complete t...
evaluate the absolute bioavailability of oral crizotinib to IV crizotinib.
Healthy
healthy volunteers crizotinib absolute bioavailability pharmacokinetics
null
1
arm 1: Each subject will receive single oral and IV doses of crizotinib separated by at least 14 days.
[ 0 ]
2
[ 0, 0 ]
intervention 1: Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed. intervention 2: Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.
intervention 1: crizotinib intervention 2: crizotinib
1
Brussels | N/A | Belgium | 4.34878 | 50.85045
28
0
0
0
NCT01168934
1COMPLETED
2010-09-01
2010-08-01
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
[ 5 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
null
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.
null
Glaucoma Ocular Hypertension
null
2
arm 1: COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) arm 2: LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours. intervention 2: 1 drop of bimatoprost 0.03% opht...
intervention 1: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution intervention 2: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops
1
Dallas | Texas | United States | -96.80667 | 32.78306
121
0
0
0
NCT01170884
1COMPLETED
2010-09-01
2009-12-01
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
[ 4 ]
129
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the superiority and efficacy of infliximab induction therapy in chinese participants with moderate to severe plaque-type psoriasis (scaly skin rash) compared with placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinica...
This is a double-blind (neither physician nor participant knows the treatment that the participant receives), multicenter (when more than one hospital or medical school team work on a medical research study) and placebo-controlled study of infliximab in participants with moderate to severe plaque-type psoriasis. All th...
Psoriasis
Psoriasis Infliximab Remicade
null
2
arm 1: 5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm intervention 2: 5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo...
intervention 1: Placebo intervention 2: Infliximab
7
Beijing | N/A | China | 116.39723 | 39.9075 Beijng | N/A | China | N/A | N/A Dalian | N/A | China | 121.60222 | 38.91222 Jinan | N/A | China | 116.99722 | 36.66833 Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Xi'an | N/A | China | 108.92861 | 34.25833
129
0
0
0
NCT01177800
1COMPLETED
2010-09-01
2009-02-01
Xian-Janssen Pharmaceutical 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
[ 2 ]
54
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
true
0ALL
false
Compare the acute effect on the QT interval of MAP0004 (Dihydroergotamine Mesylate delivered by Oral Inhalation) with Moxifloxacin and Placebo.
null
Healthy
Healthy Volunteers
null
6
arm 1: There was 48 hour wash-out between treatment visits. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4. Tablets were orally administered ...
[ 5, 5, 5, 5, 5, 5 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol intervention 2: Placebo for Inhaler administered in Treatments A and C intervention 3: 400mg encapsulated tablet administered in Treatment A as per protocol intervention 4: Placebo for Moxifloxacin administered in Treatment B and T...
intervention 1: MAP0004 intervention 2: Inhaler Placebo intervention 3: Moxifloxacin intervention 4: Placebo Capsule
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
162
0
0
0
NCT01191723
1COMPLETED
2010-09-01
2010-08-01
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
[ 5 ]
20
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
Since diabetic platelets are characterized by an enhanced turnover rate, it may be hypothesized that an increase in the frequency, rather than the dose, of drug administration may be a more effective strategy to inhibit platelet reactivity in diabetic patients as this may enable COX-1 blockade of newly generated platel...
null
Type 2 Diabetes Mellitus Coronary Artery Disease
diabetes mellitus, coronary artery disease, aspirin therapy
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one...
intervention 1: Aspirin
1
Jacksonville | Florida | United States | -81.65565 | 30.33218
20
0
0
0
NCT01201785
1COMPLETED
2010-09-01
2009-01-01
University of Florida
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 ]
68
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of log10 colony forming units (CFU) per ml sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A cont...
null
Pulmonary Tuberculosis
Bedaquiline Sirturo Early Bactericidal Activity EBA Pulmonary Tuberculosis TMC207
null
5
arm 1: TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14 arm 2: TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14. arm 3: TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14 arm 4: TMC207- 200 mg Day 1 and 100 mg Days 2-14 arm 5: Rifafour e-275 mg
[ 0, 0, 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: TMC207 intervention 2: Rifafour e-275 mg
1
Belville | Cape Town | South Africa | 18.63486 | -33.89404
68
0
0
0
NCT01215110
1COMPLETED
2010-09-01
2010-04-01
Global Alliance for TB Drug Development
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 ]
32
RANDOMIZED
CROSSOVER
null
2DOUBLE
true
0ALL
false
The hypothesis underlying the proposed study is that the blunted endothelium-dependent vasodilation seen in the airway of current smokers is also present in the brachial artery, and that the same inhaled corticosteroid (ICS) treatment regime that reversed endothelial function in the airway of current smokers will also ...
Cigarette smoking can lead to systemic endothelial dysfunction. Since the airway circulation is exposed to a high concentration of cigarette smoke constituents, we reasoned that airway vascular endothelial dysfunction could be present in healthy smokers without systemic endothelial dysfunction. The purpose of this stu...
Tobacco Abuse Smoke
smokers inhaled corticosteroids brachial flow airway blood flow albuterol spirometry endothelial dysfunction
null
3
arm 1: The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) . The subjects and the investigators will be blinded to the random choice of inhaler. arm 2: The current smokers will be given a 3-week treatment course of inhaled placebo MDI...
[ 1, 2, 4 ]
2
[ 0, 0 ]
intervention 1: 220 ug twice a day for 3 weeks intervention 2: Placebo for 3 weeks
intervention 1: Fluticasone intervention 2: Placebo
1
Miami | Florida | United States | -80.19366 | 25.77427
30
0
0
0
NCT01216735
1COMPLETED
2010-09-01
2008-09-01
University of Miami
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 ]
25
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
3TRIPLE
true
0ALL
false
Purpose and Background The purpose of this research study is to investigate the benefits of mixing lidocaine and bupivacaine for numbing the skin. Lidocaine and bupivacaine are two commonly used medications to numb the skin for minor procedures. Lidocaine has a faster onset. Bupivacaine has a longer duration. They are ...
Procedures During your participation the following procedures will be completed: * You will be asked to read over and sign this consent form, if you choose to participate * You will be asked demographic information and your medical history will be obtained * If you are eligible to participate, the palm side of your f...
Pain
null
4
arm 1: 0.2ml 1% Lidocaine with Epinephrine (1:100,000) arm 2: 0.2 ml 0.25% Bupivacaine with epinephrine (1:200,000) arm 3: 0.2ml 0.5% Lidocaine + 0.125% Bupivacaine with Epinephrine (1:150,000) arm 4: 0.2ml 1% Lidocaine + 0.25% Bupivacaine with Epinephrine (1:150,000)
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 0.2ml Intradermal injection once. intervention 2: 0.2ml Intradermal injection once. intervention 3: 0.2ml Intradermal injection once. intervention 4: 0.2ml Intradermal injection once.
intervention 1: 1% Lidocaine with Epinephrine (1:100,000) intervention 2: 0.25% Bupivacaine with Epinephrine (1:200,000) intervention 3: 0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000) intervention 4: 1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)
1
Temple | Texas | United States | -97.34278 | 31.09823
25
0
0
0
NCT01243112
1COMPLETED
2010-09-01
2010-05-01
Scott and White Hospital & 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
[ 5 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
2MALE
true
We hypothesize that paricalcitol and calcitriol in dose-dependent manner are effective for the management of chronic allograft dysfunction (CAD), protection and repair of kidney and heart, management of chronic renocardiac syndrome (CRS). We assume that paricalcitol can have some advantages if compare with calcitriol o...
Paricalcitol and calcitriol are identically effective for the management of chronic allograft dysfunction (CAD), protection and repair of kidney and heart, management of chronic renocardiac syndrome (CRS). Vitamin D can reduce progression of CAD. Activation of VDR in proximal part of nephron leads to rapid non-genomic ...
Cardiorenal Syndrome Chronic Allograft Nephropathy
chronic allograft nephropathy stem-progenitor cells cardiorenal syndrome calcitriol paricalcitol cholecalciferol cardiac repair renal repair
null
4
arm 1: 6-8 μg daily per os (orally) without special diet arm 2: 2-4 μg daily orally under with dietary restrictions of vitamin D arm 3: alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day arm 4: intake of cholecalciferol in food and multivitamins, less than 400-900 ...
[ 1, 1, 1, 5 ]
4
[ 0, 0, 0, 7 ]
intervention 1: paricalcitol group (6-8 μg daily per os - orally - without special diet) intervention 2: calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D) intervention 3: cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day) inte...
intervention 1: Paricalcitol intervention 2: Calcitriol intervention 3: Cholecalciferol intervention 4: Supplemental
2
Rotterdam | South Holland | Netherlands | 4.47917 | 51.9225 Yekaterinburg | N/A | Russia | 60.6122 | 56.8519
120
0
0
0
NCT01265615
1COMPLETED
2010-09-01
2009-10-01
Ural State Medical 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 ]
40
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study dura...
Schizophrenia
Schizophrenia Paliperidone Extended Release (ER) INVEGA
null
1
arm 1: Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
[ 0 ]
1
[ 0 ]
intervention 1: Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
intervention 1: Paliperidone extended release (ER)
2
Chiang Mai | N/A | Thailand | 98.98468 | 18.79038 Songkhla | N/A | Thailand | 100.5951 | 7.19882
40
0
0
0
NCT01387542
1COMPLETED
2010-09-01
2009-08-01
Janssen-Cilag Ltd.,Thailand
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 ]
4
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
2MALE
false
To determine the absorption, metabolism and excretion of BIA 9-1067.
Monocentre, open, non-placebo-controlled, single-group, single-dose study
Parkinson Disease
Parkinson Disease BIA 9-1067
null
1
arm 1: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
[ 0 ]
1
[ 0 ]
intervention 1: 90 µCi (3.33 MBq) \[14C\]-labeled of 100 mg BIA 9-1067 (single-dose).
intervention 1: BIA 9-1067
1
Allschwil | Base | Switzerland | 7.53599 | 47.55074
4
0
0
0
NCT01515891
1COMPLETED
2010-09-01
2009-05-01
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
[ 5 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
A randomized, double-blind controlled trial comparing treatment outcomes between chlordiazepoxide, or gabapentin to treat alcohol withdrawal syndrome in alcohol dependent veteran subjects. The objective of this trial is to compare the safety and effectiveness of these two medications. Intervention is a fixed dose taper...
Chlordiazepoxide 25 mg and matching placebo capsules or gabapentin 300 mg and matching placebo capsules were were used. The chlordiazepoxide/placebo and gabapentin/placebo capsules were not identical in appearance. Study medications were packaged into a 7-day medication organizer. The dosing for each subject was either...
Alcohol Withdrawal
null
2
arm 1: Chlordiazepoxide 25mg capsule or matching placebo capsule arm 2: Gabapentin 300mg capsule or matching placebo capsule
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: 25mg four times daily x 3 days then tapered over 3 days intervention 2: 300mg four times daily x 3 days then tapered over 3 days
intervention 1: Chlordiazepoxide intervention 2: Gabapentin
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
26
0
0
0
NCT01573052
1COMPLETED
2010-09-01
2004-03-01
VA Salt Lake City Health Care System
1FED
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 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.
This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The d...
Pain
Pain Cancer Osmotic Release Oral System OROS Hydromorphone Jurnista
null
1
arm 1: OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and do...
[ 0 ]
1
[ 0 ]
intervention 1: OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic rati...
intervention 1: Osmotic Release Oral System (OROS) hydromorphone
0
null
20
0
0
0
NCT01648699
6TERMINATED
2010-09-01
2010-04-01
Janssen Pharmaceutica
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 ]
528
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS). Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200...
This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to FMS. Subjects were randomised in a 1:1:1:1 ratio to receive placebo, ESL 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows: Sc...
Fibromyalgia
fibromyalgia Eslicarbazepine acetate (BIA 2-093) ESL
null
4
arm 1: Tablets arm 2: Eslicarbazepine acetate (BIA 2-093) tablets arm 3: Eslicarbazepine acetate (BIA 2-093) tablets arm 4: Eslicarbazepine acetate (BIA 2-093) tablets
[ 2, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Tablets intervention 2: tablets intervention 3: tablets intervention 4: tablets
intervention 1: Placebo intervention 2: ESL 400 mg intervention 3: ESL 800 mg intervention 4: ESL 1200 mg
0
null
528
0
0
0
NCT01820585
1COMPLETED
2010-09-01
2009-04-01
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
[ 5 ]
20
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
3TRIPLE
true
1FEMALE
true
The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners. We hypothesize, based on previous estrogen studies done by our group, that intercourse will interfere with absorpt...
The effects of intercourse on the absorption of vaginal progesterone for the female user and her sexual partner have not been studied. However, a previous study performed by our group found that intercourse lowered the absorption of vaginal estrogen cream in women, and men absorbed a small but statistically significant...
Infertility Pregnancy
Assisted reproductive technology Infertility Progesterone Vaginal gel Luteal-phase support
null
2
arm 1: Crinone is a bioadhesive vaginal gel containing micronized progesterone in an emulsion system containing a water swellable but insoluble polymer, polycarbophil. Crinone 8% is formulated to provide a long-acting vaginal retention, and is prescribed daily. Each applicator delivers 1.125 grams of Crinone gel contai...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator. intervention 2: Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
intervention 1: Crinone vaginal progesterone gel intervention 2: Placebo vaginal gel
1
Charlotte | North Carolina | United States | -80.84313 | 35.22709
40
0
0
0
NCT01959464
1COMPLETED
2010-09-01
2008-11-01
Wake Forest University Health Sciences
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 ]
44
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is to test two study drugs, one of which is temazepam (15mg) and one of which is a placebo (an inactive substance that looks just like the temazepam), to see if insomnia (trouble sleeping) can be reduced in patients with HIV infection. Placebos are given in research studies to try and make sur...
null
Insomnia
Insomnia HIV
null
2
arm 1: After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks. arm 2: After screening, all subjects mee...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Temazepam 15 mg orally at bedtime intervention 2: None
intervention 1: Temazepam intervention 2: Placebo
0
null
41
0
0
0
NCT02153788
1COMPLETED
2010-09-01
2009-09-01
Duke 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 ]
25
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To evaluate the safety and efficacy of lenalidomide with dexamethasone in Japanese patients with previously treated multiple myeloma.
null
Multiple Myeloma
null
1
arm 1: Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamet...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Lenalidomide 25mg PO for (days 1 - 21) of a 28-day cycle intervention 2: Dexamethasone 40 mg by mouth (PO) daily (QD) on days 1-4, 9-12 and 17-20 of each 28 day cycle
intervention 1: Lenalidomide intervention 2: Dexamethasone
8
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Fukuoka | Fukuoka | Japan | 130.41667 | 33.6 Kyoto | Kyoto | Japan | 135.75385 | 35.02107 Niigata | Niigata | Japan | 139.04125 | 37.92259 Osaka | Osaka | Japan | 135.50107 | 34.69379 Tokushima | Tokushima | Japan | 134....
25
0
0
0
NCT00928486
1COMPLETED
2010-09-10
2009-04-28
Celgene
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 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A study to assess the safety, tolerability, and single dose pharmacokinetics of a marketed drug in pediatric subjects with migraines. After completion of a portion of the study (Panels A and B), a regulatory agency issued an amended request that the 12-17 year old age group studied should include a similar number of m...
null
Migraine Disorders
null
6
arm 1: Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1. Subjects weighing 20-39 kg were allocated to Panel A. arm 2: Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tabl...
[ 0, 2, 0, 2, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: A single dose of rizatriptan 5 mg administered on Day 1. intervention 2: A single dose of rizatriptan 10 mg administered on Day 1. intervention 3: A single dose of rizatriptan 5 mg placebo administered on Day 1. intervention 4: A single dose of rizatriptan 10 mg placebo administered on Day 1.
intervention 1: rizatriptan benzoate (5 mg) intervention 2: rizatriptan benzoate (10 mg) intervention 3: Rizatriptan 5 mg Placebo intervention 4: Rizatriptan 10 mg Placebo
0
null
31
0
0
0
NCT00604812
1COMPLETED
2010-09-17
2007-12-17
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 ]
643
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study was to compare the safety and efficacy of the preservative-free formulation of 0.0015% MK2452 (tafluprost) and preservative-free 0.5% timolol maleate in patients with open-angle glaucoma and ocular hypertension. This study was to demonstrate that the preservative-free formulation of 0.0015% tafluprost is non...
null
Open-angle Glaucoma Ocular Hypertension
null
2
arm 1: Preservative-free tafluprost arm 2: Preservative-free timolol maleate
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks intervention 2: One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks
intervention 1: Preservative-Free Tafluprost intervention 2: Comparator: timolol
0
null
643
0
0
0
NCT01026831
1COMPLETED
2010-09-17
2010-01-06
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
[ 3 ]
227
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The primary purpose of this study is to determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days, and to characterize the pharmacokinetic profile of SRT2104 after a single dose and multiple administrations in type 2...
Study Objectives Primary: 1. To determine the safety and tolerability of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) in type 2 diabetic subjects when administered once daily for 28 consecutive days. 2. To characterize the pharmacokinetic profile of SRT2104 (0.25, 0.5, 1.0, and 2.0 g/day) after a single dose and multiple ...
Diabetes Mellitus, Type 2
null
5
arm 1: The Placebo treatment group will be administered eight placebo capsules per day. Placebo will be administered orally once daily for twenty-eight consecutive days. Dosing will take place at approximately the same time every morning, approximately 15 minutes following consumption of a standardized meal and should...
[ 2, 1, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: SRT2104 will be supplied as hard gelatin capsules, with each containing 250 mg. intervention 2: Placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
intervention 1: SRT2104 intervention 2: Placebo
61
Byala | N/A | Bulgaria | 27.88865 | 42.87426 Dimitrovgrad | N/A | Bulgaria | 25.6 | 42.05 Haskovo | N/A | Bulgaria | 25.55557 | 41.93415 Pleven | N/A | Bulgaria | 24.61667 | 43.41667 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Plovdiv | N/A | Bulgaria | 24.75 | 42.15 Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/...
215
0
0
0
NCT00937326
1COMPLETED
2010-09-18
2009-08-19
Sirtris, a GSK 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
[ 3 ]
21
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This clinical trial studies how well giving fludarabine phosphate together with total-body irradiation (TBI) before donor peripheral blood stem cell transplant works in treating patients with chronic lymphocytic leukemia or small lymphocytic leukemia. Giving low doses of chemotherapy, such as fludarabine phosphate, and...
PRIMARY OBJECTIVES: I. To determine whether nonmyeloablative allogeneic hematopoietic stem cell transplantation (HSCT) from matched-related donors can improve the probability of survival 18 months after treatment for fludarabine (fludarabine phosphate)-refractory, fludarabine phosphate, cyclophosphamide, and rituximab...
B-Cell Prolymphocytic Leukemia Chronic Lymphocytic Leukemia Prolymphocytic Leukemia Recurrent Chronic Lymphocytic Leukemia Recurrent Small Lymphocytic Lymphoma Refractory Chronic Lymphocytic Leukemia T-Cell Prolymphocytic Leukemia
null
1
arm 1: NONMYELOABLATIVE CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and TBI on day 0. TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclosporine PO every 12 hours on days -3 to 180 with taper on day 56 and mycophen...
[ 0 ]
7
[ 0, 0, 3, 10, 0, 3, 4 ]
intervention 1: Given PO intervention 2: Given IV intervention 3: Undergo allogeneic peripheral blood stem cell transplant intervention 4: Correlative studies intervention 5: Given PO intervention 6: Undergo allogeneic peripheral blood stem cell transplant intervention 7: Undergo TBI
intervention 1: Cyclosporine intervention 2: Fludarabine Phosphate intervention 3: Hematopoietic Cell Transplantation intervention 4: Laboratory Biomarker Analysis intervention 5: Mycophenolate Mofetil intervention 6: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation intervention 7: Total-Body Irradia...
3
Seattle | Washington | United States | -122.33207 | 47.60621 Seattle | Washington | United States | -122.33207 | 47.60621 Torino | N/A | Italy | 11.99138 | 44.88856
21
0
0
0
NCT00060424
1COMPLETED
2010-09-22
2003-03-01
Fred Hutchinson Cancer Center
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 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Study Objectives 1. To evaluate the efficacy of the combination of dexamethasone (Decadron®), thalidomide (Thalomid®), and lenalidomide (Revlimid®) as therapy for patients with relapsed or refractory multiple myeloma (MM) who have failed prior treatment with both lenalidomide and thalidomide when used as monotherapies...
This phase II study is a treatment program for patients with relapsed or refractory multiple myeloma who have had prior treatment with both thalidomide and lenalidomide in separate regimens each used as a single agent or in combination with corticosteroids. Up to 45 patients will be enrolled. Patients who sign informed...
Multiple Myeloma
myeloma relapsed or refractory multiple myeloma
null
1
arm 1: All patients were treated with the DexTR (dexamethasone / thalidomide, lenalidomide (Revlimid®)), which consisted of lenalidomide 25mg/day during days 1-21, dexamethasone 40mg/day on days 1-4, 9-12, and 17-20, and thalidomide 50mg/day for the first 7 days, followed by 100mg/day for all subsequent days, for a tot...
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Cycles 1-4 • Dexamethasone (40mg ) will be given on days 1-4, 9-12, 17-20 of a 28-day cycle. After completing 4 cycles: * Patients who demonstrate disease progression at any time will be taken off study. * Patients who achieve a resolution of monoclonal gammopathy as detected on serum immunofixation o...
intervention 1: dexamethasone intervention 2: thalidomide intervention 3: lenalidomide
1
New York | New York | United States | -74.00597 | 40.71427
5
0
0
0
NCT00538824
6TERMINATED
2010-09-22
2007-12-01
Weill Medical College of Cornell 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 ]
191
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.
null
Alzheimer's Disease
Alzheimer's disease PF-04447943 efficacy safety plasma concentrations
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: tablets, 25 mg every 12 hours for 12 wks intervention 2: matching placebo tablets, every 12 hours for 12 wks
intervention 1: PF-04447943 intervention 2: Placebo
44
Northport | Alabama | United States | -87.57723 | 33.22901 Costa Mesa | California | United States | -117.91867 | 33.64113 Glendale | California | United States | -118.25508 | 34.14251 Newport Beach | California | United States | -117.92895 | 33.61891 Rancho Mirage | California | United States | -116.41279 | 33.73974 S...
191
0
0
0
NCT00930059
1COMPLETED
2010-09-22
2009-09-10
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 ]
137
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
The purpose of this study is to evaluate elagolix (NBI-56418) compared to placebo for its effects on endometriosis related pelvic pain and its safety.
Participants were randomized (1:1) to 150 mg elagolix once daily or placebo once daily for the first 8 weeks of the study. Following 8 weeks of dosing, participants continued in the study for an additional 16 weeks in an open-label phase where all participants still enrolled in the study received 150 mg elagolix once d...
Endometriosis, Pain
Pelvic Pain,NBI-56418,Endometriosis
null
2
arm 1: Participants received 150 mg elagolix orally once a day for 8 weeks during the double-blind treatment period and continued to receive 150 mg elagolix for 16 additional weeks during the open-label treatment period. arm 2: Participants received placebo orally once a day for 8 weeks during the double-blind treatmen...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Matching placebo tablets taken orally once a day intervention 2: Immediate release (IR) tablets taken orally once a day
intervention 1: Placebo intervention 2: Elagolix
0
null
200
0
0
0
NCT00973973
1COMPLETED
2010-09-22
2009-10-12
AbbVie
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 ]
41
RANDOMIZED
null
0TREATMENT
2DOUBLE
true
0ALL
false
This study will compare how well EXC 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. The study will also evaluate the safety of EXC 001 in healthy adult subjects.
null
Scar Prevention
Scarring Cicatrix Fibrosis Pathologic Process
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Multiple intradermal injections of EXC 001 and placebo intervention 2: Multiple intradermal injections of EXC 001 and placebo
intervention 1: EXC 001 intervention 2: Placebo
6
La Jolla | California | United States | -117.2742 | 32.84727 Chicago | Illinois | United States | -87.65005 | 41.85003 St Louis | Missouri | United States | -90.19789 | 38.62727 St Louis | Missouri | United States | -90.19789 | 38.62727 Eugene | Oregon | United States | -123.08675 | 44.05207 Tualatin | Oregon | United ...
106
0
0
0
NCT01037985
1COMPLETED
2010-09-22
2009-12-03
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 ]
47
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.
null
Non-Hodgkin's Lymphoma
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 1
intervention 1: rituximab
15
Pescara | Abruzzo | Italy | 14.20283 | 42.4584 Pescara | Abruzzo | Italy | 14.20283 | 42.4584 Rionero in Vulture | Basilicate | Italy | 15.6711 | 40.92328 Reggio Calabria | Calabria | Italy | 15.66129 | 38.11047 Modena | Emilia-Romagna | Italy | 10.92539 | 44.64783 Reggio Emilia | Emilia-Romagna | Italy | 10.63125 | 44...
47
0
0
0
NCT01153971
1COMPLETED
2010-09-24
2005-07-20
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 ]
22
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study was conducted to assess the pharmacokinetic (PK) profile, safety, and tolerability in participants with Stage 3 and 4 Chronic Kidney Disease (CKD) following a single oral dose of Vadadustat.
null
Chronic Kidney Disease
CKD CKD, Stage 3 CKD, Stage 4 Vadadustat pharmacokinetics
null
2
arm 1: Participants with Stage 3 Chronic Kidney Disease (CKD) (Estimated Glomerular Filtration Rate \[eGFR\] 30 - 59 milliliters \[mL\]/minute) received a single 500 milligram (mg) oral dose of Vadadustat after fasting for at least 4 hours. arm 2: Participants with Stage 4 CKD (eGFR \<30 mL/minute and not yet on dialys...
[ 0, 0 ]
1
[ 0 ]
intervention 1: oral capsules
intervention 1: Vadadustat
2
Saint Paul | Minnesota | United States | -93.09327 | 44.94441 Knoxville | Tennessee | United States | -83.92074 | 35.96064
22
0
0
0
NCT04707573
1COMPLETED
2010-09-24
2010-07-08
Akebia 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 ]
78
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is an open label study of mepolizumab 750 mg intravenous in those subjects who participated in study 100185 to evaluate the long term safety and efficacy of mepolizumab in subjects with hypereosinophilic syndrome. The study will also evaluate the optimal dosing frequency for clinical use, the effects on corticoste...
null
Hypereosinophilic Syndrome
Mepolizumab Open-label Anti-IL-5 Hypereosinophilic Syndrome Hypereosinophilia
null
1
arm 1: 750mg Intravenous, monthly and individual dosing schedule
[ 0 ]
1
[ 0 ]
intervention 1: Study Drug
intervention 1: mepolizumab
24
San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Bethesda | Maryland | United States | -77.10026 | 38.98067 Boston | Massachusetts | United States | -71.05977 | 42.35843 Rochester | Minnesota | United States | -92.4699 | 44.02163 Cincinnati | Ohio |...
78
1
0.012821
1
NCT00097370
6TERMINATED
2010-09-29
2004-09-30
GlaxoSmithKline
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
0.002267
[ 3 ]
19
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study is an international, open-label, multi-center, Phase II, multiple dose, dose-finding study to investigate the safety, tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH. Patients who meet the inclusion/exclusion criteria will enter the Treatment Phase at ...
This study is an international, open-label, multi-center, Phase II, multiple dose, dose-finding study to investigate the safety, tolerability and pharmacokinetic characteristics of BPS-MR tablets in male and female patients with PAH. All patients will be receiving background therapy with either a phosphodiesterase (PDE...
Pulmonary Arterial Hypertension
null
0
null
null
1
[ 0 ]
intervention 1: Tablets 60mcg
intervention 1: Beraprost sodium modified release
6
Torrance | California | United States | -118.34063 | 33.83585 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Dallas | Texas | United States | -96.80667 | 32.78306 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Dublin | N/A | Ireland | -6.24889 | 53.33306
19
0
0
0
NCT00781885
1COMPLETED
2010-09-30
2009-01-31
Lung Biotechnology PBC
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 ]
2,418
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
null
Atopic Dermatitis
Atopic dermatitis, children, infants, pimecrolimus
null
2
arm 1: Pimecrolimus arm 2: Topical corticosteroids
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Pimecrolimus cream 1 % intervention 2: TCS
intervention 1: Pimecrolimus intervention 2: Topical corticosteroids
31
Phoenix | Arizona | United States | -112.07404 | 33.44838 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 Bellflower | California | United States | -118.11701 | 33.88168 Huntington Beach ...
2,418
1
0.000414
0
NCT00120523
1COMPLETED
2010-10-01
2004-04-01
MEDA Pharma GmbH & Co. KG
4INDUSTRY
false
false
false
null
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
0.000073