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
[ 4 ]
102
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Photodynamic therapy (PDT) is the selective destruction of abnormal cells through light activation of a photosensitiser in the presence of oxygen. These cells accumulate more photosensitiser than normal cells. The photosensitiser generates reactive oxygen species upon illumination. For skin diseases, there has been an...
Prospective, open, multicenter study. The high risk BCC lesions were treated with Metvix cream. A biopsy confirming the diagnosis of each BCC lesion should have been taken within 6 months prior to treatment. The participants was receive one or two treatment cycles each consisting of two Metvix PDT treatments 7 days apa...
Basal Cell Carcinoma
Photodynamic therapy (PDT) PDT with Metvix cream "High risk" BCC Basal Cell carcinoma Histologically confirmed complete response
null
1
arm 1: Participants with basal cell carcinoma (BCC) lesions were administered to photodynamic therapy (PDT) with Metvix® cream 160 milligrams per gram (mg/g) applied for three hours, followed by illumination using non-coherent light with a fluency of 75 Joule per centimeter square (J/cm\*2) and fluency rate of 70-200 m...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Metvix® cream
7
Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Carnia | Queensland | Australia | N/A | N/A Adelaide | South Australia | Australia | 138.59863 | -34.92866 Adelaide | South Australia | Australia | 138.59863 | -34.92866 Heidelberg | Victoria | Australia | 145.06667 | -37.75 Fremantle | Western Australia | Au...
102
0
0
0
NCT00473343
1COMPLETED
2006-06-01
2000-09-01
Galderma R&D
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 ]
297
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving pain due to Diabetic Neuropathy.
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex in subjects with pain due to diabetic neuropathy. Subjects were screened to determine eligibility and completed a seven-day base...
Pain Diabetic Neuropathy
Pain diabetic neuropathy
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/...
intervention 1: Sativex intervention 2: Placebo
1
Sheffield | Yorkshire | United Kingdom | -1.4659 | 53.38297
297
0
0
0
NCT00710424
1COMPLETED
2006-06-01
2005-07-01
Jazz Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 2 ]
9
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
* DermaVir is a plasmid DNA-containing synthetic nanomedicine. It is administered topically with DermaPrep to target Langerhans cells. Langerhans cells with DermaVir migrate to lymph nodes and express HIV-like particles that induce immune responses to kill HIV-infected cells. * Hypothesis: Single DermaVir immunization ...
This study enrolled nine HIV-infected adult subjects in three sequential dose cohorts. All had durable suppression of HIV-RNA on HAART over the previous 6 months and CD4 count over 300 cells/mm3. Subjects, received on study Day 0 a single DermaVir immunization: * Low dose: 0.1 mg pDNA, 0.8 mL DermaVir administered und...
HIV Infection
HIV Vaccine Immune Therapy DermaVir
null
3
arm 1: Single low-dose DermaVir immunization * 0.1 mg pDNA/subject, 0.8 mL total volume of DermaVir * Administered topically with DermaPrep under two skin patches (0.4 mL/patch) arm 2: Single medium-dose DermaVir immunization * 0.4 mg pDNA/subject, 3.2 mL total volume of DermaVir * Administered topically with DermaPr...
[ 0, 0, 0 ]
2
[ 2, 0 ]
intervention 1: DermaVir is a synthetic pathogen-like nanomedicine. The active pharmaceutical ingredient is a plasmid DNA expressing fifteen HIV proteins that assemble into HIV-like particles. These particles are safe, cannot replicate, integrate or reverse transcribed. DermaVir is targeted to Langerhans cells with Der...
intervention 1: DermaVir intervention 2: HAART
1
Budapest | Budapest | Hungary | 19.04045 | 47.49835
9
0
0
0
NCT00712530
1COMPLETED
2006-06-01
2005-01-01
Genetic Immunity
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 ]
12
NON_RANDOMIZED
SINGLE_GROUP
7BASIC_SCIENCE
0NONE
false
0ALL
false
This study was designed to estimate the effects of methotrexate (MTX) on the pharmacokinetics (PK) of CP-690,550 when administered to subjects with rheumatoid arthritis (RA), to estimate the effects of CP-690,550 on the PK of MTX and to evaluate the short-term safety and tolerability of co-administration of CP-690,550 ...
null
Rheumatoid Arthritis
Pharmacokinetics oral JAK inhibitor methotrexate (MTX) rheumatoid arthritis (RA)
null
1
arm 1: Individual dose of methotrexate with the addition of CP-690,550 30 mg q12h
[ 0 ]
2
[ 0, 0 ]
intervention 1: CP-690,550 30 mg q12h for 5 days intervention 2: individual dose of methotrexate (stably dosed)
intervention 1: CP-690,550 (tofacitinib) intervention 2: Methotrexate (MTX)
4
Daytona Beach | Florida | United States | -81.02283 | 29.21081 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Miramar | Florida | United States | -80.23227 | 25.98731 Dallas | Texas | United States | -96.80667 | 32.78306
36
0
0
0
NCT01745055
1COMPLETED
2006-06-01
2005-04-01
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 ]
40
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance
This was an open-label, single-dose (BIA 2-093 800 mg tablet), single-centre study in five groups of subjects with various degrees of renal function based on creatinine clearance (stages of renal function according to the Food and Drug Administration and the European Agency for the Evaluation of Medicinal Products Guid...
Epilepsy
null
5
arm 1: normal renal function (creatinine clearance \> 80 mL/min) arm 2: mild renal impairment (creatinine clearance 50-80 mL/min) arm 3: moderate renal impairment (creatinine clearance 30-50 mL/min) arm 4: severe renal impairment (creatinine clearance \<30 mL/min) arm 5: end stage renal disease, requiring haemodialysis...
[ 5, 5, 5, 5, 5 ]
1
[ 0 ]
intervention 1: None
intervention 1: BIA 2-093
1
Bloemfontein | Bloemfontein | South Africa | 26.214 | -29.12107
40
0
0
0
NCT02281422
1COMPLETED
2006-06-01
2005-03-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
94
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is: * to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants * to explore the pharmacokinetics (PK) of sugammadex in pediatric and adult participants,...
null
Anesthesia
null
5
arm 1: Participants are to receive an intravenous (IV) single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 0.5 mg/kg sugammadex is to be given. arm 2: Participants are to receive an IV single bolus dose of 0.6 mg/kg rocuronium. At reappearance of T2, an IV single bolus dose of 1...
[ 0, 0, 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: IV infusion intervention 2: IV infusion intervention 3: IV infusion intervention 4: IV infusion intervention 5: IV infusion intervention 6: IV infusion
intervention 1: Sugammadex 0.5 mg/kg intervention 2: Sugammadex 1 mg/kg intervention 3: Sugammadex 2 mg/kg intervention 4: Sugammadex 4 mg/kg intervention 5: Placebo intervention 6: Rocuronium bromide
0
null
91
0
0
0
NCT00421148
1COMPLETED
2006-06-02
2005-05-30
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 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
null
To investigate the preliminary pharmacokinetics, pharmacodynamics, safety and tolerability of GW823093 at doses of 15mg and 30mg given once daily for 7 days in Japanese Type 2 diabetes mellitus (T2DM) patients.
null
Diabetes Mellitus, Type 2
pharmacodynamics Diabetes pharmacokinetics
null
3
arm 1: Participants received two capsules of matching placebo orally once daily in the morning with 150 milliliter (mL) of water at least 15 minutes prior to breakfast for 7 Days. arm 2: Participants received one 15 milligrams (mg) of GW823093C capsule and one placebo capsule orally once daily in the morning with 150 m...
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: White opaque capsule containing 15mg of GW823093 as free base intervention 2: Matching placebo of GW823093 capsule or 15mg capsule intervention 3: White opaque capsule containing 15mg of GW823093 as free base
intervention 1: GW823093 15mg intervention 2: GW823093 placebo capsule intervention 3: GW823093 30mg
1
N/A | N/A | N/A | N/A | N/A
30
0
0
0
NCT00372957
1COMPLETED
2006-06-28
2006-03-22
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
[ 3 ]
210
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This trial will evaluate the efficacy and safety of brivaracetam (at doses of 5, 20 and 50 mg/day in twice a day administration) as add-on therapy in subjects with focal epilepsy.
null
Epilepsy
Epilepsy: partial onset seizures brivaracetam
null
4
arm 1: Matching Placebo tablets administered twice a day arm 2: Brivaracetam 5 mg/day, 2.5 mg administered twice a day arm 3: Brivaracetam 20 mg/day, 10 mg administered twice a day arm 4: Brivaracetam 50 mg/day, 25 mg administered twice a day
[ 2, 0, 0, 0 ]
2
[ 10, 0 ]
intervention 1: Daily oral dose of two equal intakes, morning and evening, of Placebo in a double-blinded way for the 7-week Treatment Period intervention 2: Daily oral dose of two equal intakes, morning and evening, of Brivaracetam over the 7-week Treatment Period
intervention 1: Placebo intervention 2: Brivaracetam
42
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Bradenton | Florida | United States | -82.57482 | 27.49893 Jacksonville | Florida | United States | -81.65565 | 30.33218 Chicago | Illinois ...
208
0
0
0
NCT00175825
1COMPLETED
2006-06-29
2005-11-07
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
97
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
false
0ALL
null
The Protocol section needs to be updated using the following text "The main goal of the study was to validate the Preference Module of the EARNS-Q and to test the reliability using Treatment Satisfaction Questionnaire for Medicines (TSQM), a validated questionnaire for determining satisfaction among different treatment...
null
Rhinitis, Allergic, Perennial
questionnaire nasal spray Seasonal allergic rhinitis nasal spray questionnaire allergic rhinitis
null
0
null
null
2
[ 0, 0 ]
intervention 1: Beclomethasone dipropionate intervention 2: Flunisolide
intervention 1: Beclomethasone dipropionate intervention 2: Flunisolide
7
Fresno | California | United States | -119.77237 | 36.74773 Napa | California | United States | -122.28553 | 38.29714 Roseville | California | United States | -121.28801 | 38.75212 San Francisco | California | United States | -122.41942 | 37.77493 San Jose | California | United States | -121.89496 | 37.33939 San Jose |...
194
0
0
0
NCT00346775
1COMPLETED
2006-06-29
2006-05-01
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
[ 5 ]
96
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The overall objective of the study is to develop recommendations for treatment programs to help alcoholic smokers to stop smoking. A sample of 175 alcohol dependent cigarette smokers will be recruited from the community and treated in a 6-month outpatient alcohol and tobacco treatment program. The 175 patients will be ...
null
Smoking Alcoholism
Smoking Alcoholism
null
2
arm 1: Subjects in both arms were instructed to use one 21-mg (Nicoderm CQ®) nicotine patch daily for 8 weeks followed by one 14-mg patch daily for 2 weeks, then followed by one 7-mg patch daily for 2 weeks, for a total of 12 weeks of nicotine patch therapy. Placebo gum was given for ad libitum use, with encouragement ...
[ 2, 1 ]
4
[ 5, 0, 0, 0 ]
intervention 1: Individual 60-minute treatment sessions were scheduled weekly for the first 3 months, then monthly for the next 3 months for a total of 16 sessions. Alcohol treatment was based on the cognitive behavioral therapy manual developed for Project MATCH, with approximately 40-45 minutes of each session devote...
intervention 1: Cognitive Behavior Therapy for alcohol and smoking cessation intervention 2: Nicoderm CQ nicotine patch intervention 3: Placebo gum intervention 4: Nicotine gum - Nicorette®
1
Newington | Connecticut | United States | -72.72371 | 41.69788
96
0
0
0
NCT00064844
1COMPLETED
2006-07-01
2002-08-01
Yale University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
328
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome ...
null
Narcolepsy Sleep Apnea, Obstructive Sleep Apnea Syndromes Shift-Work Sleep Disorder
Excessive Sleepiness Narcolepsy Cataplexy Sleep Attacks Obstructive Sleep Apnea Obstructive Sleep Hypopnea nCPAP Chronic Shift Work Sleep Disorder Chronic SWSD Circadian Rhythm Disorder Shift Worker Cepahlon Cephalon, Inc Nuvigil
null
0
null
null
1
[ 0 ]
intervention 1: Armodafinil (po) 100 to 250 mg/day up to 12 months
intervention 1: CEP-10953 (Armodafinil)
50
Peoria | Arizona | United States | -112.23738 | 33.5806 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Lafayette | California | U...
323
0
0
0
NCT00078312
1COMPLETED
2006-07-01
2004-01-01
Cephalon
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
91
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to determine the safety and tolerability of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes) and Chronic Renal Insufficiency (inadequate kidney function).
null
Diabetes Mellitus, Type 2 Chronic Renal Insufficiency
Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
null
2
arm 1: Participants in the Sitagliptin treatment sequence will receive sitagliptin in Phase A and placebo to glipizide in Phase B. arm 2: Participants in the Placebo treatment sequence will receive placebo to sitagliptin in Phase A and glipizide in Phase B.
[ 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: One (participants with visit 1 estimated creatinine clearance \<30 mL/min or undergo regular dialysis) or Two (participants with visit 1 creatinine clearance of =30 to \<50 mL/min; not on dialysis) tablets of 25 mg Sitagliptin daily. intervention 2: One (participants with visit 1 estimated creatinine cl...
intervention 1: sitagliptin intervention 2: Placebo to Sitagliptin intervention 3: glipizide intervention 4: Placebo to glipizide
0
null
91
0
0
0
NCT00095056
1COMPLETED
2006-07-01
2004-10-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
61
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjec...
null
Kidney Transplantation
tofacitinib CP-690550 kidney transplant
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 15 mg twice daily intervention 2: 30 mg twice daily intervention 3: dose adjusted according to level
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: tacrolimus
20
Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 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 | 37.774...
61
0
0
0
NCT00106639
1COMPLETED
2006-07-01
2005-05-01
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
[ 4 ]
3,494
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
null
The objective of this study is to determine the comparative efficacy and safety of two oral regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin, in prevention of venous thromboembolism in patients with primary elective total hip replacement surgery.
null
Thromboembolism Arthroplasty, Replacement, Hip
null
3
arm 1: daily dose 150 mg once daily, half a dose on the day of surgery arm 2: daily dose 220 mg once daily, half a dose on the day of surgery arm 3: 40 mg once daily
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: daily dose 150 mg once daily, half a dose on the day of surgery intervention 2: daily dose 150 mg once daily, half a dose on the day of surgery intervention 3: 40 mg once daily
intervention 1: dabigatran etexilate intervention 2: dabigatran etexilate intervention 3: enoxaparin
116
Garren | Australian Capital Territory | Australia | N/A | N/A Kogarah | New South Wales | Australia | 151.13564 | -33.9681 Lismore | New South Wales | Australia | 153.2773 | -28.81354 Bedford Park | South Australia | Australia | 138.56815 | -35.02204 Box Hill | Victoria | Australia | 145.12545 | -37.81887 Clayton | Vic...
3,463
0
0
0
NCT00168818
1COMPLETED
2006-07-01
2004-11-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
26
RANDOMIZED
PARALLEL
1PREVENTION
3TRIPLE
false
0ALL
true
The broad, long-term objectives of this proposal are to prevent the emergence of posttraumatic stress and depressive symptoms in children admitted for an acute burn, reconstructive surgery, or non-burn injury. This study is investigating the early use of a medication in the prevention of posttraumatic stress disorder a...
RESEARCH DESIGN AND METHODS 1. SPECIFIC AIM 1: To assess the efficacy of sertraline in preventing posttraumatic stress disorder in children aged 6-20 after a burn, injury or reconstructive surgery following a burn injury. 2. SPECIFIC AIM 2: To assess the efficacy of sertraline in preventing co-morbid depression in chi...
Posttraumatic Stress Disorder Depression
sertraline children adolescents posttraumatic stress disorder depression prevention burns injuries
null
2
arm 1: Placebo was administered on a flexible fixed schedule and tapered at 12 weeks. arm 2: Sertraline was administered on a flexible fixed schedule beginning at 25 mg/day and increasing as high as 150 mg/day. At week 12, the medication was tapered at a rate of 25 mg every 3 days until it was discontinued.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinue...
intervention 1: Placebo intervention 2: Sertraline
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
26
0
0
0
NCT00182078
1COMPLETED
2006-07-01
2002-11-01
Massachusetts General 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
[ 0 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This research study will look at the safety (e.g., the occurrence of side effects) and efficacy (how well the drug works in reducing trigeminal neuralgia attacks) of a drug called lamotrigine in adults with trigeminal neuralgia.
A randomized, double-blind, placebo-controlled, add-on study of lamotrigine in trigeminal neuralgia. Thirty-eight eligible patients with trigeminal neuralgia will be enrolled; nineteen will be randomized to the active medication group and nineteen to the placebo group. Using a daily diary, all patients will document th...
Trigeminal Neuralgia
Double-Blind Placebo-Controlled
null
2
arm 1: Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg arm 2:...
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal). This drug is an anti-seizure medication. intervention 2: The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotri...
intervention 1: lamotrigine intervention 2: Placebo
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
14
0
0
0
NCT00203229
1COMPLETED
2006-07-01
2003-06-01
Thomas Jefferson University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
112
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to demonstrate the effectiveness and safety of the Alair System for the treatment of asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy. One-hundred and ten subjects will be randomized 1:1 to eit...
Multicenter, randomized, controlled clinical trial conducted at 11 Investigational Sites in 4 countries (Canada, United Kingdom, Denmark, and Brazil). Subjects underwent Baseline evaluations, Alair treatments or Control Visits, and follow-up evaluations at 12-Weeks, 6-Months, and 12-Months after the last Treatment or ...
Asthma
Asthma Bronchial Thermoplasty Airway Hyperresponsiveness
null
2
arm 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. arm 2: Conventional therapy with ICS+LABA.
[ 0, 1 ]
2
[ 3, 0 ]
intervention 1: Conventional therapy with ICS+LABA plus bronchial thermoplasty with the Alair System. intervention 2: Conventional therapy with ICS+LABA.
intervention 1: Bronchial thermoplasty with the Alair System intervention 2: Conventional therapy with ICS+LABA
0
null
218
0
0
0
NCT00214526
1COMPLETED
2006-07-01
2002-11-01
Asthmatx, 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 ]
136
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
SURFAXIN® (lucinactant) treatment will be examined in very low birth weight infants to prevent development of chronic lung disease, commonly known as bronchopulmonary dysplasia (BPD), in premature infants who have required continued intubation and received surfactants for the prevention or treatment of respiratory dist...
Determine the safety and tolerability of SURFAXIN administration in the first weeks of life as a therapeutic approach for prevention of BPD. Determine whether treatment with SURFAXIN during the first two to three weeks of life can decrease the proportion of infants on mechanical ventilation or oxygen or the incidence o...
Respiratory Distress Syndrome, Newborn Premature Birth Bronchopulmonary Dysplasia
Double-blind Low Birth Weight Surfactant Placebo-Controlled Premature Birth
null
3
arm 1: SURFAXIN (lucinactant) at 175 mg/kg arm 2: SURFAXIN (lucinactant) at 90 mg/kg arm 3: Sham air using 3.0 mL/kg volume of air
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Administered via slow intra-tracheal instillation at a dose of 175 mg/kg (5.8 mL/kg of a 30-mg/mL suspension). Initial treatment given no later than 1 hour after randomization. Additional treatments were administered every 48 hours up to a maximum of 5 doses (up to day of life (DOL) 18). intervention 2:...
intervention 1: Lucinactant 175 mg/kg intervention 2: Lucinactant 90 mg/kg intervention 3: Placebo
1
Warrington | Pennsylvania | United States | -75.13406 | 40.24927
136
0
0
0
NCT00215540
6TERMINATED
2006-07-01
2005-02-01
Windtree Therapeutics
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
743
NON_RANDOMIZED
FACTORIAL
0TREATMENT
0NONE
false
0ALL
null
A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
null
Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome Chronic Shift Work Sleep Disorder
null
1
arm 1: Armodafinil 100 to 250 mg/day
[ 0 ]
1
[ 0 ]
intervention 1: Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD).
intervention 1: Armodafinil 100 to 250 mg/day
100
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Anaheim | California | United States | -117.9145 | 33.83529 Beverly Hills | Califor...
731
0
0
0
NCT00228553
1COMPLETED
2006-07-01
2004-05-01
Cephalon
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
247
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient res...
null
Excessive Daytime Sleepiness Narcolepsy Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS)
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Armodafinil
43
Birmingham | Alabama | United States | -86.80249 | 33.52066 Tuscaloosa | Alabama | United States | -87.56917 | 33.20984 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United ...
246
0
0
0
NCT00228566
1COMPLETED
2006-07-01
2005-10-01
Cephalon
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
40
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Patients with multiple myeloma (MM) and non-Hodgkin's lymphoma (NHL) will be mobilized with chemotherapy and G-CSF plus plerixafor (AMD3100). The purpose of this protocol is to determine if plerixafor given after chemotherapy and G-CSF mobilization regimen is safe, if it can increase the circulating levels of periphera...
An open label, multi-center, phase 2 study was conducted in patients with MM or NHL who were to be treated with peripheral blood stem cells (PBSC) autologous transplantation. The only change to the standard of care was the addition of plerixafor to a mobilization regimen of chemotherapy and G-CSF. Patients were first g...
Lymphoma, Non-Hodgkin Multiple Myeloma
Non-Hodgkin's Lymphoma Multiple Myeloma Stem cell mobilization
null
4
arm 1: Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg...
[ 0, 0, 0, 0 ]
1
[ 0 ]
intervention 1: G-CSF and plerixafor were administered as described in the treatment arms.
intervention 1: G-CSF and plerixafor
5
Duarte | California | United States | -117.97729 | 34.13945 Beech Grove | Indiana | United States | -86.08998 | 39.72199 Rochester | New York | United States | -77.61556 | 43.15478 Portland | Oregon | United States | -122.67621 | 45.52345 Seattle | Washington | United States | -122.33207 | 47.60621
40
0
0
0
NCT00322387
1COMPLETED
2006-07-01
2004-04-01
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
[ 5 ]
41
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
false
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes. Epidural analgesia is commonly performed after the parturient feels labor pain. We hypothesis that preemptive epidural analgesi...
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studi...
Obstetric Pain
Epidural analgesia labor cytokines
null
2
arm 1: Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS\<3). arm 2: Parturients with cervical dilatation and painful labor (VAS \>5) will receive epidural analgesia as soon as possible
[ 0, 1 ]
2
[ 3, 0 ]
intervention 1: Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions. intervention 2: Epidural analgesia with parturients with cervical dilatation and painful labor (VAS \>5...
intervention 1: Preemptive epidural analgesia intervention 2: Standard of care
1
Petah Tikva | N/A | Israel | 34.88747 | 32.08707
41
0
0
0
NCT00361712
1COMPLETED
2006-07-01
2006-07-01
Rabin 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
[ 4 ]
82
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate sleep onset following administration of Transcept zolpidem tartrate sublingual tablet versus placebo in adult insomnia patients.
null
Insomnia
Insomnia
null
6
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved. intervention 2: Zolpidem tartrate...
intervention 1: zolpidem tartrate sublingual tablet 3.5mg intervention 2: zolpidem tartrate sublingual tablet 1.75mg intervention 3: Placebo
0
null
243
0
0
0
NCT00380081
1COMPLETED
2006-07-01
2006-04-01
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
[ 2 ]
318
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part ...
null
Osteoporosis
null
4
arm 1: Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. arm 2: Participants in Part 1 received 70mg alendronate tablet in Period 1 follow...
[ 0, 0, 0, 0 ]
3
[ 0, 0, 7 ]
intervention 1: A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence. intervention 2: A single dose tablet of 70mg alendronate in one treatment period of each sequence. intervention 3: Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one tre...
intervention 1: alendronate sodium+vitamin D combination intervention 2: Comparator: alendronate intervention 3: Comparator: Vitamin D
0
null
608
0
0
0
NCT00803790
1COMPLETED
2006-07-01
2006-05-01
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
[ 3 ]
320
null
null
null
null
null
0ALL
null
Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in patients with dry eye, using a multicenter, randomized, double-blind, parallel group comparison study, and the optimal concentration is determined.
null
Dry Eye
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: DE-089 ophthalmic solution intervention 2: DE-089 ophthalmic solution intervention 3: Placebo ophthalmic solution
1
Osaka | Osaka | Japan | 135.50107 | 34.69379
286
0
0
0
NCT01189032
1COMPLETED
2006-07-01
null
Santen Pharmaceutical Co., Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
Single centre, open-label, randomised study in four parallel groups of healthy volunteers
Single centre, open-label, randomised study in four parallel groups of healthy volunteers: Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093); Group 2 = 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine; Group 3 = 450 mg of S-licarbazepine; Group 4 = 450 mg of Rlicarbazepine. In each group, the study c...
Epilepsy
null
4
arm 1: 900mg of eslicarbazepine acetate (ESL, BIA 2-093) arm 2: 450 mg of S-licarbazepine plus 450 mg of R-licarbazepine arm 3: 450 mg of S-licarbazepine arm 4: 450 mg of Rlicarbazepine
[ 0, 1, 1, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets containing 900 mg intervention 2: capsules containing 225 mg intervention 3: capsules containing 225 mg
intervention 1: BIA 2-093 intervention 2: S-licarbazepine intervention 3: R-licarbazepine
1
Hamburg | N/A | Germany | 9.99302 | 53.55073
32
0
0
0
NCT02281591
1COMPLETED
2006-07-01
2006-06-01
Bial - Portela C S.A.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
301
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
null
The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with perennial allergic rhinitis (PAR).
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)
Rhinitis, Allergic, Perennial
GW685698X perennial allergic rhinitis allergic rhinitis
null
2
arm 1: Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg arm 2: Participants were instructed to administer two sprays into each nostril once daily every morning of placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: fluticasone furoate 110 μg nasal spray intervention 2: placebo nasal spray
intervention 1: FF intervention 2: Placebo
42
San Diego | California | United States | -117.16472 | 32.71571 Baltimore | Maryland | United States | -76.61219 | 39.29038 Wheaton | Maryland | United States | -77.05526 | 39.03983 North Dartmouth | Massachusetts | United States | -70.97032 | 41.63899 Minneapolis | Minnesota | United States | -93.26384 | 44.97997 Canto...
302
0
0
0
NCT00289198
1COMPLETED
2006-07-04
2006-02-07
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
84
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).
This Phase II/III study consisted of two parts: A controlled phase and An Open label extension(OLE) phase. The controlled phase describes the double blind part of the study and was intended to evaluate the efficacy of icatibant in decreasing the time to onset of symptom relief compared with placebo for the first treate...
Angioedema
Hereditary Angioedema C1 inhibitor deficiency HAE Icatibant Bradykinin antagonist acute attack subcutaneous
null
4
arm 1: Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack. arm 2: Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack. arm 3: Patients with laryngeal symptoms at the baseline were not randomised ...
[ 0, 2, 0, 0 ]
2
[ 0, 0 ]
intervention 1: 30 mg (3mL) subcutaneous icatibant injection in the abdominal region intervention 2: Solution for injection, matched to study drug Single dose: 3 mL
intervention 1: Icatibant intervention 2: Placebo
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
136
0
0
0
NCT00097695
1COMPLETED
2006-07-17
2004-12-28
Shire
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
114
RANDOMIZED
PARALLEL
1PREVENTION
null
false
0ALL
false
This study is requested by PMDA to confirm the optimal dose for THR (total hip replacement).
null
Thrombosis, Venous
Fondaparinux Hip Replacement Arthroplasty VTE THR MOSLL pentasaccharide Xa factor
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: Fondaparinux
1
N/A | N/A | N/A | N/A | N/A
114
0
0
0
NCT00320398
1COMPLETED
2006-07-18
2006-01-30
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
[ 3 ]
375
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
This is a 24-week study investigating the safety and efficacy of several dosages of a potential new oral medicine for Type II diabetes mellitus.
A 12-Week, Parallel-Group, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Dose Ranging Study to Evaluate the Efficacy, Safety and Tolerability of GW823093, Administered Orally, Once Daily, as Monotherapy in Subjects With Type 2 Diabetes Mellitus followed by a 12-week Active Treatment Extension
Diabetes Mellitus, Type 2
NIDDM
null
6
arm 1: Participants received oral dose of matching placebo capsule to denagliptin (DEN) once daily in the morning, 30 minutes (min) prior to breakfast during the main phase 12-weeks treatment period. Participants who were randomized to placebo in the main phase 12-weeks treatment period received oral dose of DEN 2.5 mi...
[ 2, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Placebo capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 2: DEN 2.5 mg capsules which were white, opaque capsules with no identifying markings, containing white to off-white beads. intervention 3: DEN 7.5 mg capsules which were wh...
intervention 1: Placebo intervention 2: DEN 2.5 mg intervention 3: DEN 7.5 mg intervention 4: DEN 15 mg intervention 5: DEN 30 mg intervention 6: DEN 45 mg
109
Long Beach | California | United States | -118.18923 | 33.76696 Pasadena | California | United States | -118.14452 | 34.14778 Denver | Colorado | United States | -104.9847 | 39.73915 Hollywood | Florida | United States | -80.14949 | 26.0112 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | Unit...
375
0
0
0
NCT00111800
1COMPLETED
2006-07-21
2005-04-28
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
85
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
Primary Outcome Measures: The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard ...
This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE. The study consisted of two parts: controlled phase and O...
Hereditary Angioedema
null
4
arm 1: Subjects received S.C icatibant+ oral placebo Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL) Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart arm 2: Subjects received oral Tranexamic acid+ S.C. placebo T...
[ 0, 1, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist. intervention 2: over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE. intervention 3: hard capsule ma...
intervention 1: Icatibant intervention 2: Tranexamic Acid intervention 3: Oral Placebo intervention 4: S.C. Placebo
1
Milan | N/A | Italy | 12.59836 | 42.78235
131
0
0
0
NCT00500656
1COMPLETED
2006-07-25
2005-03-01
Shire
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 ]
384
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
null
Genital herpes (GH) is a commonly occurring sexually transmitted disease caused by herpes simplex virus (HSV). There are two types of HSV, type 1 (HSV-1) and type 2 (HSV-2); both can cause GH, although the latter is much more likely to produce frequent recurrences of GH lesions. Evidence suggests that there are advanta...
null
Herpes Genitalis
VALTREX® valaciclovir genital herpes HSV-2 suppression
null
2
arm 1: Participants received double blinded treatment of oral dose of Valacyclovir 1 g given as 2 x 500 mg caplets QD for 6 months (24 weeks). arm 2: Participants received double blinded treatment of oral dose of matching placebo to Valacyclovir 1 gram (g) given as 2 x 500 milligram (mg) caplets once daily (QD) for 6 m...
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 1g once daily intervention 2: placebo
intervention 1: Valaciclovir intervention 2: Placebo
72
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Anaheim | California | United States | -117.9145 | 33.83529 Beverly Hills | California | United States | -118.40036 | 34.07362 Davis | California...
383
0
0
0
NCT00158860
1COMPLETED
2006-07-26
2004-06-21
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
302
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this trial is to test the safety and efficacy of aripiprazole in adolescent patients with schizophrenia for a period of at least 6 weeks.
null
Schizophrenia
Schizophrenia Aripiprazole
null
3
arm 1: Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25 arm 2: Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10...
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Aripiprazole tablet 10 mg po qd x 42 days intervention 2: Aripiprazole tablet 30 mg po qd x 42 days intervention 3: Placebo tablet po qd x 42 days
intervention 1: Aripiprazole tablet, 10 mg intervention 2: Aripiprazole tablet, 30 mg intervention 3: Placebo tablet
55
Birmingham | Alabama | United States | -86.80249 | 33.52066 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Costa Mesa | California | United States | -117.91867 | 33.64113 Los Angeles | California | United States | -118.24368 | 34.05223 National City | California | United States | -117.0992 | 32.67811 Ora...
302
2
0.006623
1
NCT00102063
1COMPLETED
2006-08-01
2004-07-01
Otsuka Pharmaceutical Development & Commercialization, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.001818
[ 3 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This 11-week study will examine the safety and effectiveness of the medication donepezil (Aricept®) compared to placebo for treating cognitive deficits in children and adolescents with Autism Spectrum Disorder.
Children with autism spectrum disorder (ASD) often have impaired communication, problems with social interaction, and repetitive and stereotyped patterns of behavior. While most research has attempted to treat the behavioral deficits commonly associated with ASD, few studies have attempted to improve the core features ...
Autistic Disorder
null
2
arm 1: Donepezil HCL 5 mg and 10 mg arm 2: Placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants will start with 5 mg per day dose of donepezil HCl, then have their dose increased to 10mg per day after 4 weeks. intervention 2: Placebo used in placed of Donepezil HCL
intervention 1: Donepezil HCl intervention 2: Placebo
1
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
34
0
0
0
NCT00047697
1COMPLETED
2006-08-01
2002-10-01
University of Pittsburgh
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 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether telavancin (TD-6424, ARBELIC) can be safety administered to patients with bloodstream infections and whether telavancin is effective in treating these infections.
null
Gram-Positive Bacterial Infections
null
2
arm 1: None arm 2: Vancomycin 1 Gram/12 hours or nafcillin, oxacillin, or cloxacillin 2 Gram/6 hours (IV) intravenously
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Telavancin 10mg/kg/day IV every 24 hrs for up to 14 days intervention 2: Vancomycin 1 Gram every 12 hr IV (intravenously) OR nafcillin, oxacillin, or cloxacillin 2 Grams every 6 hr IV (intravenously) for up to 14 days.
intervention 1: Telavancin intervention 2: Vancomycin, nafcillin, oxacillin, or cloxacillin
1
Marietta | Georgia | United States | -84.54993 | 33.9526
58
0
0
0
NCT00062647
1COMPLETED
2006-08-01
2003-08-01
Cumberland Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
627
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days ...
null
Colorectal Cancer
null
2
arm 1: Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m\^2 intravenous (IV) infusion over 2 hours (every 3 weeks \[Day 1\]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a d...
[ 0, 1 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: As prescribed, in 2 week cycles intervention 2: As prescribed, in 2 week cycles intervention 3: As prescribed, in 3 week cycles intervention 4: As prescribed, in 2 week cycles intervention 5: 1000mg/m2 po bid on days 1-15 of each 3 week cycle
intervention 1: 5 FU intervention 2: Leucovorin intervention 3: Oxaliplatin intervention 4: Oxaliplatin intervention 5: capecitabine [Xeloda]
87
Bakersfield | California | United States | -119.01871 | 35.37329 Colorado Springs | Colorado | United States | -104.82136 | 38.83388 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Terre Haute | Indiana | United States | -87.41391 | 39.4667 St Louis | Missouri | United States | -90.19789 |...
619
0
0
0
NCT00069108
1COMPLETED
2006-08-01
2003-07-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
307
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
1FEMALE
true
The primary aim of this study is to test if the addition of behavioral treatment to drug therapy for the treatment of urge incontinence will increase the number of patients who can discontinue drug therapy and sustain a significant reduction of incontinence.
null
Urinary Incontinence (UI)
Urge urinary incontinence (UUI) Drug/Behavior treatment
null
2
arm 1: Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication (tolterodine) and behavioral training. arm 2: Women assigned to this arm received 10 weeks of anti-cholinergic medication (tolterodine), only.
[ 0, 1 ]
2
[ 0, 5 ]
intervention 1: 4mg/d for 10 weeks. Could be reduced to 2mg/d for managing side effects. intervention 2: Training in pelvic floor muscle control and exercises; behavioral strategies to diminish urgency, suppress bladder contractions and prevent incontinence; delayed voiding; and individualized fluid management.
intervention 1: Tolterodine intervention 2: Behavioral training
9
Birmingham | Alabama | United States | -86.80249 | 33.52066 San Diego | California | United States | -117.16472 | 32.71571 Maywood | Illinois | United States | -87.84312 | 41.8792 Baltimore | Maryland | United States | -76.61219 | 39.29038 Royal Oak | Michigan | United States | -83.14465 | 42.48948 Pittsburgh | Pennsyl...
307
0
0
0
NCT00090584
1COMPLETED
2006-08-01
2004-08-01
Carelon Research
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
205
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in...
Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches: A. Overview/Aims: Five million Americans present to emergency departments (ED) annually with headaches \[1\]. The majority of these patients have migraine headaches \[2,3\]. Parenteral medications of proven benefit for acute migraines include the t...
Migraine
migraine, emergency department, dexamethasone Migraine with or without aura or probable migraine without aura as defined by ICHD, 2nd edition
null
2
arm 1: Dexamethasone 10 mg arm 2: Placebo Dexamethasone, 10 mg
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Dexamethasone 10mg IV intervention 2: Placebo Dexamethasone 10mg IV
intervention 1: Dexamethasone intervention 2: Placebo
3
Manhattan | New York | United States | -73.96625 | 40.78343 New York | New York | United States | -74.00597 | 40.71427 The Bronx | New York | United States | -73.86641 | 40.84985
205
0
0
0
NCT00122278
1COMPLETED
2006-08-01
2005-07-01
Montefiore 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
[ 2, 3 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to find the highest safe dose and to assess the anti-tumor effect of liposomal vincristine with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL).
OBJECTIVES: * Determine the maximum tolerated dose (MTD) of liposomal vincristine given with dexamethasone in patients with relapsed or refractory acute lymphoblastic leukemia (ALL). * Determine the efficacy of liposomal vincristine given with dexamethasone in these patients.
Acute Lymphoblastic Leukemia
null
1
arm 1: Vincristine Sulfate Liposomes Injection (VSLI)
[ 0 ]
2
[ 0, 0 ]
intervention 1: Study treatment consists of infusion of VSLI intravenously over 60 minutes on Day 1 and Days 8, 15 and 22 (+/- 2 days). intervention 2: Study treatment consists of 40 mg dexamethasone, daily orally or intravenously, on Days 1-4 (+/- 2 days) and Days 11-14 (+/- 2 days).
intervention 1: Vincristine Sulfate Liposomes Injection intervention 2: Dexamethasone
3
Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United States | -87.65005 | 41.85003 Houston | Texas | United States | -95.36327 | 29.76328
36
0
0
0
NCT00144963
1COMPLETED
2006-08-01
2002-07-01
Acrotech Biopharma Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
500
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salm...
This trial will attempt to investigate whether asthmatic patients that are well controlled with low-dose twice daily inhaled corticosteroid (ICS) therapy can safely be switched to other modes of controller therapy without loss of asthma control. Patients demonstrating good control on twice-daily low-dose ICS will be ra...
Asthma
Asthma Asthma Control
null
3
arm 1: Participants continued fluticasone (100 microgram twice daily) treatment. arm 2: Participants were changed to Montelukast (5 or 10 mg each night). arm 3: Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.
[ 1, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: fluticasone (100 microgram twice daily) treatment intervention 2: Montelukast (5 or 10 mg each night). intervention 3: fluticasone (100 microgram) plus salmeterol (50 microgram) each night
intervention 1: fluticasone intervention 2: montelukast intervention 3: Fluticasone plus salmeterol
19
Birmingham | Alabama | United States | -86.80249 | 33.52066 Denver | Colorado | United States | -104.9847 | 39.73915 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Georgia | United States | -84.38798 | 33.749 Chicago | Illinois | United Sta...
495
0
0
0
NCT00156819
1COMPLETED
2006-08-01
2003-06-01
JHSPH Center for Clinical Trials
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 ]
249
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis
Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of sympto...
Multiple Sclerosis
Multiple Sclerosis
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: CNTO 1275
0
null
249
0
0
0
NCT00207727
1COMPLETED
2006-08-01
2004-07-01
Centocor, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 0 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of the Alair System for the treatment of severe refractory asthma. This will be a multicenter, randomized controlled study comparing the effects of treatment with the Alair System to standard drug therapy in patients with severe asthma refractory to stan...
Multicenter, randomized, clinical trial conducted at 8 Investigational Sites in 3 countries. Subjects in the Alair group to be administered the Alair treatment in 3 separate bronchoscopy sessions, while subjects in the Control group will complete 3 "Control Visits" to the Physicians office, timed to coincide with the ...
Asthma
Asthma Bronchial Thermoplasty
null
2
arm 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. arm 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids a...
[ 0, 1 ]
2
[ 3, 0 ]
intervention 1: Alair treatment plus standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral corticosteroids at a dose of ≤ 30 mg/day. intervention 2: Standard-of-care therapy of high dose inhaled corticosteroids and long acting beta-agonists with or without oral...
intervention 1: Bronchial Thermoplasty with the Alair System intervention 2: Control
0
null
96
0
0
0
NCT00214539
1COMPLETED
2006-08-01
2004-04-01
Boston Scientific 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
[ 4 ]
461
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, ma...
Benign Prostatic Hyperplasia (BPH)
Benign prostatic hyperplasia, BPH, alpha blocker
null
2
arm 1: Silodosin 8 mg once daily with food arm 2: Matching Placebo capsule once daily with food
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 8 mg daily for 12 weeks intervention 2: 1 capsule daily for 12 weeks
intervention 1: Silodosin intervention 2: Placebo
43
Huntsville | Alabama | United States | -86.58594 | 34.7304 Tucson | Arizona | United States | -110.92648 | 32.22174 Anaheim | California | United States | -117.9145 | 33.83529 Culver City | California | United States | -118.39647 | 34.02112 Irvine | California | United States | -117.82311 | 33.66946 La Jolla | Californ...
461
0
0
0
NCT00224107
1COMPLETED
2006-08-01
2005-05-01
Watson Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
48
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
2MALE
null
To evaluate inter-ethnic similarity in pharmacodynamics between Japanese and Caucasian healthy adult male subjects by comparing electrophysiological reactions after administering E2014 to extensor digitorum brevis muscle (EDB).
null
Spasmodic Torticollis
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: A single-dose injection solution containing 20 units (U), 100 U, or 500 U/ 0.2 milliliters (mL) of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese and Caucasian participants. Duration of treatment lasted for 12 weeks: from Day -1 to Week 12. Participan...
intervention 1: E2014 (Botulinum toxin type B) intervention 2: E2014 (Botulinum toxin type B) Placebo
1
Kagoshima | Kagoshima-ken | Japan | 130.55 | 31.56667
48
0
0
0
NCT00280384
1COMPLETED
2006-08-01
2006-01-01
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
[ 4 ]
411
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
true
0ALL
false
The purpose of this study is to determine the safety and efficacy of VEC-162 compared to placebo to improve sleep parameters in a model of insomnia.
null
Insomnia
null
4
arm 1: Take orally 30 minutes prior to bedtime. arm 2: 20 mg taken orally 30 minutes prior to bedtime. arm 3: 50 mg taken orally 30 minutes prior to bedtime. arm 4: 100 mg taken orally 30 minutes prior to bedtime.
[ 2, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 20 mg VEC-162 intervention 2: 50 mg VEC-162 intervention 3: 100 mg VEC-162 intervention 4: Placebo
intervention 1: 20 mg VEC-162 intervention 2: 50 mg VEC-162 intervention 3: 100 mg VEC-162 intervention 4: Placebo
19
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 Santa Monica | California | United States | -118.49138 | 34.01949 Miami ...
411
0
0
0
NCT00291187
1COMPLETED
2006-08-01
2006-02-01
Vanda 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
[ 0 ]
16
RANDOMIZED
SINGLE_GROUP
0TREATMENT
2DOUBLE
true
0ALL
false
The objective of this study is to assess the comparative utility of topical formulations in hastening the resolution of skin bruising. For each subject, four standard bruises of 7 mm diameter each were created on the bilateral upper inner arms, 5 cm apart, two per arm, using a 595-nm pulsed-dye laser. Randomization was...
null
Ecchymosis
Bruising Topical 20% arnica
null
1
arm 1: Bruises at three time points: immediate after bruise creating, and at 1 and 2 weeks.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Topical formation applied to bruise twice daily for 2 weeks. intervention 2: Topical formation applied to bruise twice daily for 2 weeks. intervention 3: Topical formation applied to bruise twice daily for 2 weeks. intervention 4: Topical formation applied to bruise twice daily for 2 weeks.
intervention 1: Petrolatum United States Pharmacopeia (USP) intervention 2: Vitamin K and retinol ointment intervention 3: Arnica ointment intervention 4: Vitamin K ointment
1
Chicago | Illinois | United States | -87.65005 | 41.85003
16
0
0
0
NCT00363038
1COMPLETED
2006-08-01
2006-07-01
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
[ 3 ]
5
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This Phase 2 study was designed to assess the safety and hematological activity of AMD3100 (plerixafor) in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. Patients with NHL and MM were eligible to enter the...
A Phase 2, single-center, open-label study to assess the safety and hematological activity of plerixafor in patients with non-Hodgkin's lymphoma (NHL) or multiple myeloma (MM) who were predicted to be unable to mobilize ≥2\*10\^6 CD34+ cells/kg within 3 apheresis days. The only change to the standard of care was the ad...
Multiple Myeloma Lymphoma, Non-Hodgkin's
Non-Hodgkin's Lymphoma Multiple Myeloma stem cell mobilization autologous transplantation AMD3100
null
1
arm 1: Patients who were predicted to be unable to mobilize a minimum number of cells (≥2\*10\^6 CD34+ cells/kg) in 3 apheresis days when given granulocyte colony-stimulating factor (G-CSF) alone and who were eligible for autologous peripheral blood stem cell transplantation.
[ 0 ]
1
[ 0 ]
intervention 1: Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morni...
intervention 1: G-CSF plus plerixafor
1
Durham | North Carolina | United States | -78.89862 | 35.99403
5
0
0
0
NCT00395967
6TERMINATED
2006-08-01
2005-04-01
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
[ 5 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
The purpose of this study is to evaluate the cardiac safety of Caelyx in patients with metastatic breast cancer who have previously received chemotherapy with anthracyclines.
null
Breast Neoplasm
null
1
arm 1: Pegylated Lyposomal Doxorubicin (Caelyx) 50 mg/m2, given for 6 cycles
[ 0 ]
1
[ 0 ]
intervention 1: Pegylated Liposomal Doxorubicin (Caelyx) IV, 50 mg/m2 once every 4 weeks for 6 cycles or until disease progression, whichever is earlier. Patients still receiving clinical benefit after a total of 6 cycles of Caelyx, may continue therapy at the discretion of the investigator.
intervention 1: Pegylated Liposomal Doxorubicin
0
null
1
0
0
0
NCT00779285
6TERMINATED
2006-08-01
2006-02-01
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
[ 2 ]
32
RANDOMIZED
CROSSOVER
null
0NONE
true
1FEMALE
false
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablet) in healthy, adult subjects administered under fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Healthy
Bioequivalence Healthy Subjects
null
2
arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets
intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
64
0
0
0
NCT01182194
1COMPLETED
2006-08-01
2006-06-01
Teva Pharmaceuticals USA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
33
RANDOMIZED
CROSSOVER
null
0NONE
true
1FEMALE
false
This study was designed to compare the relative bioavailability (rate and extent of absorption) of 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets with that of YAZ® Tablets (by Berlex, Inc.) following a single, oral dose (2 x 3 mg/0.02 mg tablets) in healthy, adult subjects under non-fasting conditions.
Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA Bioequivalence Statistical Methods
Healthy
Bioequivalence Healthy Subjects
null
2
arm 1: Drospirenone/Ethinyl Estradiol Tablets, 3 mg/0.02 mg arm 2: YAZ® Tablets, 3 mg/0.02 mg
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 3 mg/0.02 mg Tablets intervention 2: 3 mg/0.02 mg Tablets
intervention 1: Drospirenone/Ethinyl Estradiol (Gianvi®) intervention 2: YAZ®
1
Fargo | North Dakota | United States | -96.7898 | 46.87719
66
0
0
0
NCT01182207
1COMPLETED
2006-08-01
2006-07-01
Teva Pharmaceuticals USA
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
529
RANDOMIZED
PARALLEL
null
0NONE
false
0ALL
null
The purpose of this study is to evaluate the effects on blood pressure control, pulse wave velocity, as well as safety and tolerability of felodipine single or combine with other drugs in Chinese Hypertension patients.
In this study, investigators will choose male and female subjects aged between 35 and 79 years old with mild to moderate essential hypertension. At first 2 weeks, all patients will use felodipine 5mg daily. If the blood pressure dosen't meet the target (140/90mmHg), they will be randomized into metoprolol, lisinopril o...
Hypertension
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 1, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th ...
intervention 1: Felodipine tablet (Plendil) alone intervention 2: Felodipine tablet (Plendil)+Hydrochlorothiazide intervention 3: Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK) intervention 4: Felodipine tablets (Plendil)+Lisinopril (Zestril)
0
null
522
0
0
0
NCT02336607
1COMPLETED
2006-08-01
2005-12-01
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 ]
75
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to demonstrate the efficacy, and to examine patient acceptability (simplicity and usefulness) and rate of successful self-injection.
null
Migraine Disorders
Migraine Sumatriptan Succinate Injection Kit Cluster Headache self-injection
null
1
arm 1: Sumatriptan
[ 0 ]
1
[ 0 ]
intervention 1: Sumatriptan Succinate
intervention 1: Sumatriptan Succinate
4
Aichi | N/A | Japan | 130.62158 | 32.51879 Hyōgo | N/A | Japan | 144.43333 | 43.36667 Kyoto | N/A | Japan | 135.75385 | 35.02107 Tokyo | N/A | Japan | 139.69171 | 35.6895
132
0
0
0
NCT00356603
1COMPLETED
2006-08-07
2006-06-20
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
[ 3 ]
50
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this research study is to find how breast cancer responds to the investigational drug, Ispinesib. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. In particular, this study will try is to find the answers to the...
null
Neoplasms, Breast
breast cancer
null
1
arm 1: Females with advanced or metastatic breast cancer were administered Ispinesib
[ 0 ]
1
[ 0 ]
intervention 1: Given intravenously at a dose of 18 milligram (mg)/ meter square (m\^2).
intervention 1: Ispinesib
13
Jacksonville | Florida | United States | -81.65565 | 30.33218 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Brussels | N/A | Belgium | 4.34878 | 50.85045 Bandar Tun Razak, ...
50
0
0
0
NCT00089973
1COMPLETED
2006-08-25
2004-06-30
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
[ 3 ]
100
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The objective of the trial was to establish the dose-response relation of sugammadex (Org 25969) given as a reversal agent of rocuronium or vecuronium at reappearance of T2 (the amplitude of the first response of second twitch to train of four (TOF) stimulation, expressed as percentage of control first twitch, T1) duri...
For most surgical procedures a depth of neuromuscular block of 1-2 twitches after TOF-stimulation is sufficient to avoid unwanted muscular activity. At reappearance of T2, the anesthesiologist might decide to either give (another) maintenance dose of rocuronium or vecuronium when surgery continues, to await spontaneous...
Anesthesia, General
null
10
arm 1: After induction of anesthesia an intubation dose of 0.9 mg/kg rocuronium was administered intravenously (IV), followed by maintenance doses of 0.1-0.2 mg/kg rocuronium IV if necessary. At reappearance of T2 a single dose of placebo was administered IV. arm 2: After induction of anesthesia an intubation dose of 0...
[ 2, 0, 0, 0, 0, 2, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: After induction of anesthesia an intubation dose of (Neuromuscular blocking agent) NMBA was administered IV: either 0.9 mg/kg rocuronium or 0.1 mg/kg vecuronium. Maintenance doses of 0.1-0.2 mg/kg rocuronium IV or 0.02-0.03 mg/kg vecuronium IV could be administered if necessary. At reappearance of T2 ...
intervention 1: Sugammadex intervention 2: Placebo intervention 3: Rocuronium intervention 4: Vecuronium
0
null
98
0
0
0
NCT00552617
1COMPLETED
2006-08-31
2005-09-20
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 ]
961
RANDOMIZED
SINGLE_GROUP
1PREVENTION
2DOUBLE
false
0ALL
false
Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.
null
Deep Vein Thrombosis Fibrillation, Atrial Venous Thromboembolism Pulmonary Embolism
deep vein thrombosis total knee replacement PE Venous thromboembolism DVT pulmonary embolism VTE
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Odiparcil intervention 2: Warfarin intervention 3: Coumadin
101
Birmingham | Alabama | United States | -86.80249 | 33.52066 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Banning | California | United States | -116.87641 | 33.92557 Sacramento | California...
954
1
0.001048
1
NCT00244725
1COMPLETED
2006-09-01
2005-09-01
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
1
0
0
0
0
0
0
0
0.000185
[ 2 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I trial to study the effectiveness of benzoylphenylurea in treating patients who have advanced solid tumors.
OBJECTIVES: * Determine the maximum tolerated dose of benzoylphenylurea in patients with advanced solid tumors. * Evaluate the acute and chronic toxicity profile of this regimen in these patients. * Evaluate the pharmacokinetics and metabolites of this regimen and any potential correlation with pharmacodynamic effects...
Unspecified Adult Solid Tumor, Protocol Specific
unspecified adult solid tumor, protocol specific
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: benzoylphenylurea
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
19
0
0
0
NCT00016354
1COMPLETED
2006-09-01
2001-03-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
9
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of this study is to look at the safety and effectiveness of ONTAK in previously treated patients with NHL.
null
Non-Hodgkin's Lymphoma Lymphoma, B-cell Lymphoma, Low-grade
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: ONTAK
2
Lexington | Kentucky | United States | -84.47772 | 37.98869 Metairie | Louisiana | United States | -90.15285 | 29.98409
9
0
0
0
NCT00051025
1COMPLETED
2006-09-01
2000-05-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
211
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
Patients with CF often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called PA. Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The pur...
Cystic Fibrosis
Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: AZLI 75 mg two times a day (BID)/three times a day (TID) intervention 2: Placebo two times a day (BID)/three times a day (TID)
56
Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California | United States | -117.2742 | 32.84727 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Orange | Calif...
211
0
0
0
NCT00104520
1COMPLETED
2006-09-01
2005-02-01
Gilead Sciences
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 ]
61
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will treat hemodialysis patients who have a central catheter that is thought to be infected with a specific bacteria (Gram positive bacteria).
Pfizer suspended enrollment on 21 August 2006 as a precautionary measure in light of the mortality imbalance seen in a similar study, and terminated the study on April 6, 2007 due to factors affecting the timeline to completion, such as slow enrollment and inclusion of sufficient evaluable subjects.
Bacteremia Gram-Positive Bacterial Infections
null
0
null
null
3
[ 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None
intervention 1: Cefazolin IV intervention 2: Linezolid IV intervention 3: Vancomycin (IV)
17
Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038 Barranquilla | Atlántico | Colombia | -74.78132 | 10.96854 Bogota | Cundinamarca | Colombia | N/A | N/A Bogotá | D.C | Colombia | -74.08175 ...
61
0
0
0
NCT00108433
6TERMINATED
2006-09-01
2005-09-01
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
[ 4 ]
300
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
To assess the safety and efficacy of 10 milligram (mg) twice a day (b.i.d.) Fampridine-SR in patients diagnosed with multiple sclerosis (MS), in a double-blind, placebo-controlled, parallel group study.
Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the arms and legs. In people with MS, the fatty sheath that surrounds and insulates the...
Multiple Sclerosis
Walking Ability
null
2
arm 1: Placebo control arm 2: 10 milligram (mg) tablet b.i.d.
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Tablets, 10 mg, twice daily, 14 weeks intervention 2: sugar pill, twice a day (b.i.d.)
intervention 1: Fampridine-SR intervention 2: Placebo
34
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 Denver | Colorado | United States | -104.9847 | 39.73915 Derby | Connectic...
300
0
0
0
NCT00127530
1COMPLETED
2006-09-01
2005-05-01
Acorda 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 ]
75
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
null
This is a randomized, double-blind, two treatment, two group, parallel group study. Subjects will be randomized to one of two treatment groups (E2007 or Placebo) in a 3 to 1 ratio and receive treatment for a total of ten weeks (Days 1 to 70).
null
Parkinson's Disease
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: E2007
10
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Oxnard | California | United States | -119.17705 | 34.1975 New Haven | Connecticut | United States | -72.92816 | 41.30815 Boca Raton | Florida | United States | -80.0831 | 26.35869 Delray Beach | Florida | United States | -80.07282 | 26.46146 St. Petersburg ...
75
0
0
0
NCT00165789
1COMPLETED
2006-09-01
2005-09-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will compare employment support with behavioral skills training to employment support alone in schizophrenia patients taking either risperidone or olanzapine to determine which is more effective in helping the patients maintain a job.
Schizophrenia is a severe mental disorder characterized by disorganized thoughts, difficulty concentrating, and hallucinations. Individuals with schizophrenia often experience reduced emotional, social, and occupational functioning. Data indicate that antipsychotic drug treatment and occupational training and support m...
Schizophrenia
Antipsychotic Agents Employment
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 1, 1, 1, 1 ]
4
[ 5, 5, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Individual Placement and Support (Supported Employment) intervention 2: Social Skills Training intervention 3: Olanzapine intervention 4: Risperidone
2
Los Angeles | California | United States | -118.24368 | 34.05223 Manchester | New Hampshire | United States | -71.45479 | 42.99564
107
0
0
0
NCT00183625
1COMPLETED
2006-09-01
2000-06-01
University of California, Los Angeles
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 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will determine the efficacy and safety of combination therapy with divalproex and lithium for treating mania in people with rapid cycling bipolar disorder and a substance abuse disorder.
Longitudinal Evaluation of the Efficacy and Safety of Divalproex and Lithium in Dual Diagnosis Bipolar Rapid Cycling: This study recruits males and females age 18 and older who currently meet diagnostic criteria for rapid cycling bipolar disorder (type I or II) and who have met the criteria for substance abuse or depen...
Bipolar Disorder
null
2
arm 1: Patients assigned to the combination group were continued on lithium and blinded divalproex. arm 2: Patients assigned to lithium monotherapy underwent divalproex-placebo substitution at a rate of 250 mg decrements every week until discontinued.
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Lithium monotherapy was initiated at 300 mg twice daily and titrated over 3-6 weeks to minimum blood levels of 0.8 meq/L. intervention 2: Divalproex was then initiated at 250 mg twice daily and increased over 3-6 weeks to minimum blood levels of 50 ug/ml. intervention 3: Placebo pills that looked exact ...
intervention 1: Lithium intervention 2: Divalproex intervention 3: Placebo
1
Cleveland | Ohio | United States | -81.69541 | 41.4995
31
0
0
0
NCT00194129
1COMPLETED
2006-09-01
1997-11-01
University Hospitals Cleveland 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
[ 4 ]
47
RANDOMIZED
CROSSOVER
1PREVENTION
2DOUBLE
false
0ALL
false
To determine the effect of an approved medication being studied in support of a new approach in the prevention of exercise-induced asthma (a worsening of asthma caused by exercise, also known as exercise-induced bronchospasm), in patients who have a history of worsening asthma after exercise.
null
Asthma, Exercise-Induced
null
6
arm 1: Montelukast - Salmeterol - Placebo arm 2: Montelukast - Placebo - Salmeterol arm 3: Salmeterol - Montelukast - Placebo arm 4: Salmeterol - Placebo - Montelukast arm 5: Placebo - Montelukast - Salmeterol arm 6: Placebo - Salmeterol - Montelukast
[ 0, 0, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 1 dose montelukast 10 mg tablet given orally in one of three treatment periods intervention 2: 1 dose of 50 ug salmeterol given by inhalation in one of three treatment periods intervention 3: 1 dose matching-image placebo to montelukast tablet in two of three treatment periods intervention 4: 1 dose mat...
intervention 1: Comparator: Montelukast intervention 2: Comparator: Salmeterol intervention 3: Comparator: Placebo (montelukast) intervention 4: Comparator: Placebo (salmeterol)
0
null
47
0
0
0
NCT00245570
1COMPLETED
2006-09-01
2005-12-01
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 ]
116
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The aim of this study is to demonstrate the effectiveness and safety of 500 units of Dysport manufactured at a new manufacturing facility in Europe.
null
Cervical Dystonia
null
2
arm 1: Drug: abobotulinumtoxinA (Dysport®) arm 2: Placebo
[ 0, 2 ]
2
[ 2, 0 ]
intervention 1: 500 units intervention 2: 500 units
intervention 1: Botulinum toxin type A intervention 2: Placebo
22
Phoenix | Arizona | United States | -112.07404 | 33.44838 Fountain Valley | California | United States | -117.95367 | 33.70918 Los Angeles | California | United States | -118.24368 | 34.05223 Gainesville | Florida | United States | -82.32483 | 29.65163 Miami | Florida | United States | -80.19366 | 25.77427 Atlanta | Ge...
116
0
0
0
NCT00257660
1COMPLETED
2006-09-01
2005-10-10
Ipsen
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 ]
34
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
null
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the seve...
The purpose of the study is to evaluate the efficacy of an anti-psychotic medication, Olanzapine, in achieving desired weight gain in patients identified as having Anorexia Nervosa, either restricting or binge/purge subtype. The study will also evaluate the possible beneficial effects of Olanzapine in reducing the seve...
Anorexia Nervosa
Pilot Project, Clinical Trial, Treatment Outcome, Psychopharmacology
null
2
arm 1: Placebo and Treatment as usual (Day Hospital Program). After a 2-week baseline period, placebo was administered for 10 weeks (weeks 3-12 of the study). Day hospital program involved attendance 4 days a week from 9:00 am to 6:00 pm for 12 to 14 weeks, and supervised meals and group therapy. arm 2: After a 2-week ...
[ 2, 0 ]
2
[ 0, 5 ]
intervention 1: After a 2-week baseline period, olanzapine was administered for 10 weeks (weeks 3-12 of the study). Olanzapine was prescribed according to a flexible dose regimen, starting at the minimum dose of at 2.5 mg/day and titrated slowly by increments of 2.5 mg/week to a maximum dose of of 10 mg/day. interventi...
intervention 1: Olanzapine intervention 2: Day Hospital
1
Ottawa | Ontario | Canada | -75.69812 | 45.41117
34
0
0
0
NCT00260962
1COMPLETED
2006-09-01
2000-09-01
Ottawa Hospital Research Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
30
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
false
Trauma patients are at increased risk for adrenal function insufficiency. A commonly used agent for rapid sequence intubation (RSI) is known to decrease adrenal function. We want to determine the incidence of adrenocortical insufficiency and its significance during the first 24 hours of resuscitation following RSI in t...
The study will have two arms. Patients on one arm will be assigned to receive etomidate (0.3 mg/kg) and succinylcholine (1mg/kg) for RSI. Patients on the other arm will receive standard therapy at this institution which consists of Versed (generic name midazolam) (5 mg) plus fentanyl (100 mcgs) as well as succinylcholi...
Adrenal Insufficiency
adrenal insufficiency etomidate rapid sequence induction
null
2
arm 1: Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications arm 2: Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: etomidate 0.3 mg/kg IV plus succinylcholine 1 mg/kg IV intervention 2: 100 micrograms fentanyl IV, plus 5 mg midazolam IV, plus 1 mg/kg succinylcholine IV
intervention 1: RSI sedation with etomidate/succinylcholine intervention 2: RSI sedation with fentanyl/midazolam/succinylcholine
1
Chattanooga | Tennessee | United States | -85.30968 | 35.04563
30
0
0
0
NCT00462644
1COMPLETED
2006-09-01
2006-02-01
University of Tennessee
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 ]
5
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
Purpose of the study is to compare the effects of megestrol acetate concentrated suspension and placebo on caloric intake for the treatment of cancer-associated anorexia in patients with lung or pancreatic cancer
null
Anorexia Cachexia Weight Loss
Megestrol acetate Anorexia Cachexia Lung cancer Pancreatic cancer Unintended weight loss Body weight Appetite Megace ES
null
2
arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Placebo suspension
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Placebo oral suspension, 5 mL once daily
intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Placebo
3
Miami | Florida | United States | -80.19366 | 25.77427 Cumberland | Maryland | United States | -78.76252 | 39.65287 Mt. Pleasant | South Carolina | United States | -79.86259 | 32.79407
5
0
0
0
NCT00637728
6TERMINATED
2006-09-01
2006-06-01
Par Pharmaceutical, 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 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
To compare the effect of megestrol acetate concentrated suspension and placebo on caloric intake in patients with cancer-associated anorexia.
null
Anorexia Cachexia Weight Loss
Megestrol acetate Anorexia Cachexia Cancer Unintended weight loss Body weight Appetite Megace ES
null
3
arm 1: Megestrol acetate concentrated suspension 110 mg/mL arm 2: Megestrol acetate concentrated suspension 60 mg/mL arm 3: None
[ 1, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Megestrol acetate concentrated suspension 110 mg/mL given as an oral dose of 550 mg (5 mL) once per day for 56 days, with an optional 28 days extension phase intervention 2: Megestrol acetate concentrated suspension 60 mg/mL given as an oral dose of 300 mg (5 mL) once per day for 56 days, with an option...
intervention 1: Megestrol acetate concentrated suspension 110 mg/mL intervention 2: Megestrol acetate concentrated suspension 60 mg/mL intervention 3: Placebo
4
Anaheim | California | United States | -117.9145 | 33.83529 Flat Rock | North Carolina | United States | -82.44151 | 35.27123 High Point | North Carolina | United States | -80.00532 | 35.95569 Akron | Ohio | United States | -81.51901 | 41.08144
5
0
0
0
NCT00637806
6TERMINATED
2006-09-01
2006-06-01
Par Pharmaceutical, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
43
NON_RANDOMIZED
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
false
0ALL
false
The purpose of this study is to assess the safety and tolerability of long term therapy with Sativex® and GW-2000-02.
Subjects who have previously participated in GWCA0101, a two week (two days baseline and two weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® (containing delta-9-tetrahydrocannabinol \[THC\] and cannabidiol \[CBD\]) and GW-2000...
Pain Cancer
Palliative Care Pain Cancer
null
2
arm 1: Active treatment arm 2: Active treatment
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Containing delta-9-tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml; both as extract of Cannabis sativa L. Subjects received study medication delivered in 100 µl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 ac...
intervention 1: Sativex intervention 2: GW-2000-02
1
Shrewsbury | N/A | United Kingdom | -2.75208 | 52.71009
43
0
0
0
NCT00675948
1COMPLETED
2006-09-01
2002-04-01
Jazz Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study will compare the effectiveness of two atypical antipsychotic medications, olanzapine and aripiprazole, in treating people with anorexia nervosa.
Anorexia nervosa (AN) is a disease of disordered eating that is characterized by self-starvation, often leading to extreme weight loss and difficulty maintaining a normal weight. Symptoms and behaviors of AN may include distorted body image, obsessive exercise, lack of menstruation among women, binge and purge eating b...
Eating Disorders
Atypical Antipsychotics Anorexia Nervosa
null
2
arm 1: Participants will take olanzapine arm 2: Participants will take aripiprazole
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Participants will take olanzapine daily for 12 weeks. intervention 2: Participants will take aripiprazole daily for 12 weeks.
intervention 1: Olanzapine intervention 2: Aripiprazole
2
New York | New York | United States | -74.00597 | 40.71427 Toronto | Ontario | Canada | -79.39864 | 43.70643
22
0
0
0
NCT00685334
1COMPLETED
2006-09-01
2003-11-01
New York State Psychiatric Institute
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
This study will determine whether the CT formulation of famotidine taken with and without water is bioequivalent to the FCT formulation. The primary hypothesis is that the area under the concentration-time curve (AUC) and the maximum plasma concentration (Cmax) of a single dose of famotidine 20 mg CT without water are ...
null
Heartburn
null
6
arm 1: Participants received famotidine 20 mg FCT as a single dose with 120 mL of water (Period 1), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water (Period 2), followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water (Peri...
[ 0, 0, 0, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Famotidine 20 mg oral film-coated tablet taken once daily intervention 2: Famotidine 20 mg oral chewable tablet taken once daily
intervention 1: Famotidine FCT intervention 2: Famotidine CT
0
null
90
0
0
0
NCT00945750
1COMPLETED
2006-09-01
2006-08-01
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
[ 4 ]
19
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic insufficiency (EPI).
The study sample will consist of evaluable participants, all of whom will be children younger than 7 years of age. Participants will receive EUR-1008 (APT-1008) Microtabs formulation. The study design involves a 4-day screening period, a 7-day dose stabilization period, and a 7-day treatment period (excluding an end-of...
Cystic Fibrosis Exocrine Pancreatic Insufficiency
Cystic fibrosis Exocrine Pancreatic Insufficiency Zenpep-1009
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: EUR-1008 (APT-1008) Microtabs contained in a capsule will be administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule will be allowed to sprinkle on food, where necessary, followed by stabilized dose from Da...
intervention 1: EUR-1008 (APT-1008)
14
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Oakland | California | United States | -122.2708 | 37.80437 Palo Alto | California | United States | -122.14302 | 37.44188 San Diego | California | United States | -117.16472 | 32.71571 Gainsvill...
19
0
0
0
NCT00981214
1COMPLETED
2006-09-01
2006-05-01
Forest Laboratories
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 ]
174
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
null
The primary objective was to evaluate the safety of dabigatran etexilate(BIBR 1048) administered orally at doses of 110 and 150 mg, twice daily, for 12 weeks in patients with non-valvular atrial fibrillation (paroxysmal, persistent or permanent) in comparison with warfarin.
null
Atrial Fibrillation
null
3
arm 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration arm 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration arm 3: Dose-adjusted warfarin based on target INR values
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Dabigatran etexilate 110 mg capsule, twice a day, oral administration intervention 2: Dabigatran etexilate 150 mg capsule, twice a day, oral administration intervention 3: Dose-adjusted warfarin based on target INR values
intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Warfarin
28
Aki-gun, Hiroshima | N/A | Japan | 132.45 | 34.4 Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Fukuoka, Fukuoka | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Iizuka,Fukuoka | N/A | Japan | N/A | N/A Kyoto, Kyoto | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Jap...
166
0
0
0
NCT01136408
1COMPLETED
2006-09-01
2005-11-01
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
[ 2 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This was a phase 1, open label, multiple dose study in healthy male and female volunteers. Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours. The objective of this study in healthy volunteers was to de...
null
Healthy Volunteers
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
intervention 1: Ketorolac tromethamine
1
Manchester | N/A | United Kingdom | -2.23743 | 53.48095
15
0
0
0
NCT01363050
1COMPLETED
2006-09-01
2006-01-01
Egalet Ltd
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
115
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of the trial is to demonstrate a faster recovery from neuromuscular block induced by 1.2 mg/kg rocuronium after reversal at 3 minutes by 16.0 mg/kg of sugammadex compared with recovery after a neuromuscular block induced by 1.0 mg/kg succinylcholine.
null
Anesthesia, General
null
2
arm 1: Participants were to receive a single bolus dose of 1.2 mg/kg rocuronium. Three minutes after the start of the rocuronium administration, they were to receive a single bolus dose of 16.0 mg/kg sugammadex. arm 2: Participants were to receive a single bolus dose of 1.0 mg/kg succinylcholine and allowed to recovery...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Single bolus intravenous (IV) dose of 16.0 mg/kg sugammadex intervention 2: Single bolus IV dose of 1.0 mg/kg succinylcholine intervention 3: Single bolus IV dose of 1.2 mg/kg rocuronium
intervention 1: Sugammadex intervention 2: Succinylcholine intervention 3: Rocuronium
0
null
110
0
0
0
NCT00474253
1COMPLETED
2006-09-09
2006-02-10
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
86
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose) rocuronium (Zemuron®) in participants diagnosed with or having a history of pulmonary diseas...
null
Anesthesia, General
null
2
arm 1: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will receive IV sugammadex 2.0 mg/kg. arm 2: After the IV intubation dose (0.6 mg/kg) or last maintenance dose (0.15 mg/kg) of rocuronium, at reappearance of T2, participants will rec...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Sugammadex solution for injection. intervention 2: Rocuronium bromide solution for injection.
intervention 1: Sugammadex intervention 2: Rocuronium
0
null
77
0
0
0
NCT00475215
1COMPLETED
2006-09-09
2005-10-27
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
135
RANDOMIZED
PARALLEL
0TREATMENT
null
false
0ALL
null
This is a multi-center, Phase III study to evaluate the safety and tolerability of proposed dose conversion recommendations for RLS subjects converting from ropinirole immediate release to ropinirole controlled-release for RLS.
null
Restless Legs Syndrome Restless Legs Syndrome (RLS)
RLS Ropinirole Restless Legs Syndrome
null
6
arm 1: Participants received Placebo in the evening and Ropinirole 1 mg IR at bedtime on Week 1. At the end of Week 1, participants were switched to receive Ropinirole 2 mg controlled release for Restless Legs Syndrome (CR-RLS) in the evening and placebo at bedtime till the end of Week 2. At the end of Week 2, particip...
[ 0, 0, 0, 0, 0, 0 ]
8
[ 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm round bi-convex white film coated tablet, de-bossed with 'GS' on both faces, containing ropinirole hydrochloride equivalent to 1.0mg of active drug substance. intervention 2: Ropinirole IR (SKF-101468) will be supplied in the form of a 7mm...
intervention 1: Ropinirole IR 1 mg intervention 2: Ropinirole IR 2 mg intervention 3: Ropinirole IR 1 mg Placebo intervention 4: Ropinirole IR 2 mg Placebo intervention 5: Ropinirole CR 2 mg intervention 6: Ropinirole CR 3 mg intervention 7: Ropinirole CR 2 mg Placebo intervention 8: Ropinirole CR 3 mg Placebo
30
Laguna Hills | California | United States | -117.71283 | 33.61252 Oxnard | California | United States | -119.17705 | 34.1975 Pasadena | California | United States | -118.14452 | 34.14778 Reseda | California | United States | -118.53647 | 34.20112 Boca Raton | Florida | United States | -80.0831 | 26.35869 St. Petersburg...
135
0
0
0
NCT00256854
1COMPLETED
2006-09-21
2005-11-14
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
[ 5 ]
48
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the safety and tolerability of PEGASYS plus ribavirin in previous intravenous (iv) drug users who have CHC and are currently enrolled in a methadone maintenance treatment program. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.
null
Hepatitis C, Chronic
null
2
arm 1: Participants will receive the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3,...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 180 micrograms sc weekly for 24 weeks (G 2/3) or 48 weeks (G 1) intervention 2: 1000/1200mg (\< or \>= 75 kg, respectively), po in two doses daily for 48 weeks (G 1) or 800 mg po in two doses daily for 24 weeks (G 2/3)
intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin
7
San Francisco | California | United States | -122.41942 | 37.77493 Farmington | Connecticut | United States | -72.83204 | 41.71982 Honolulu | Hawaii | United States | -157.85833 | 21.30694 Downers Grove | Illinois | United States | -88.01117 | 41.80892 Baltimore | Maryland | United States | -76.61219 | 39.29038 New Yor...
48
1
0.020833
1
NCT00087594
1COMPLETED
2006-10-01
2003-11-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.003687
[ 3 ]
255
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
1FEMALE
null
This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.
null
Breast Cancer Metastases Bone Metastases in Subjects With Advanced Breast Cancer
Breast Cancer Cancer
null
6
arm 1: Denosumab 60 mg by subcutaneous injection once every 12 weeks (Q12W) for 25 weeks. arm 2: Denosumab 120 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 3: Denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W) for 25 weeks. arm 4: Open label bisphosphonate every 4 weeks (Q4W)...
[ 0, 0, 0, 1, 0, 0 ]
2
[ 2, 0 ]
intervention 1: Denosumab administered by subcutaneous injection intervention 2: Commercially available intravenous (IV) bisphosphonates administered per package insert, included pamidronate, ibandronic acid, and zoledronic acid
intervention 1: Denosumab intervention 2: IV Bisphosphonates
0
null
254
0
0
0
NCT00091832
1COMPLETED
2006-10-01
2004-09-01
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
[ 4 ]
39
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.
null
Mucopolysaccharidosis VI
null
2
arm 1: N-acetylgalactosamine 4-sulfatase arm 2: None
[ 5, 5 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: N-acetylgalactosamine 4-sulfatase intervention 2: Placebo/rhASB
1
Novato | California | United States | -122.5697 | 38.10742
38
0
0
0
NCT00104234
1COMPLETED
2006-10-01
2004-02-01
BioMarin Pharmaceutical
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 ]
1
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
The purpose of the study is to determine whether pemetrexed and gemcitabine cause good tumour shrinkage when given to patients with previously untreated extensive-stage small cell lung cancer. The second purpose is to see if the side effects appear better than what is expected with standard chemotherapy.
Extensive-stage small cell lung carcinoma is incurable. Present therapies are toxic and responses are short lived. This phase II, single arm, window of opportunity study will assess the response rate and toxicity of pemetrexed and gemcitabine in this cohort.
Carcinoma, Small Cell
Lung cancer Phase II Drug Therapy
null
0
null
null
1
[ 0 ]
intervention 1: None
intervention 1: pemetrexed and gemcitabine
3
Boston | Massachusetts | United States | -71.05977 | 42.35843 Quincy | Massachusetts | United States | -71.00227 | 42.25288 Springfield | Massachusetts | United States | -72.58981 | 42.10148
1
0
0
0
NCT00129974
6TERMINATED
2006-10-01
2005-08-01
Tufts 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
[ 3 ]
68
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to evaluate the safety and efficacy of clobazam as adjunctive therapy in the treatment of seizures which lead to drop attacks (drop seizures) in subjects 2 to 30 years of age with Lennox-Gastaut Syndrome (LGS). Subjects will be enrolled at approximately 10 investigational sites in the U.S. ...
LGS poses a significant treatment challenge. While antiepileptic medications are the mainstay of treatment, no one antiepileptic drug (AED) provides satisfactory relief for all or most patients with LGS and a combination of treatments is often required. Many patients with LGS are refractory to standard AED treatment. ...
Epilepsy Epilepsy, Generalized Seizures
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 5 to 10 mg/day with doses in the morning and at bedtime; orally intervention 2: 5 to 40 mg/day with doses in the morning and at bedtime; orally
intervention 1: Clobazam Low Dose intervention 2: Clobazam High Dose
14
Phoenix | Arizona | United States | -112.07404 | 33.44838 Los Angeles | California | United States | -118.24368 | 34.05223 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Tampa | Florida | United States | -82.45843 | 27.94752 Boston | Massachusetts | United States | -71.05977 | 42.35843 Bo...
68
0
0
0
NCT00162981
1COMPLETED
2006-10-01
2005-10-01
Lundbeck 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 ]
14
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Patients who have been treated for hepatitis C virus (HCV) infection who have failed to respond to anti-viral treatment are often concerned about their ongoing liver disease and are therefore looking for alternative treatments which might prevent fibrosis progression. This view is endorsed by patient representative gro...
Background: Convincing evidence exists outlining a role for the coagulation system in the pathogenesis of liver fibrosis. In vivo and in vitro studies have suggested a role for thrombin and FXa in activating hepatic stellate cells and epidemiological studies have demonstrated that prothrombotic states accelerate liver...
Liver Fibrosis
Hepatic fibrosis anticoagulation Coumarin Warfarin Chronic hepatitis C virus infection
null
1
arm 1: Anticoagulated with warfarin to maintain an INR of 2-3 between 8 and 16 weeks (treatment period).
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Warfarin
1
London | N/A | United Kingdom | -0.12574 | 51.50853
19
0
0
0
NCT00180674
1COMPLETED
2006-10-01
2005-08-01
Imperial College London
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 ]
401
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study is randomized, Sodium Ozagrel (Thromboxane A2 Synthase Inhibitor) controlled study on acute ischemic stroke. The primary endpoints were the rate of patients with modified Rankin Scale score of 0-1 at 3 months.
null
Cerebral Infarction
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening. intervention 2: Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
intervention 1: Edaravone intervention 2: Sodium Ozagrel
0
null
392
0
0
0
NCT00200356
1COMPLETED
2006-10-01
2004-08-01
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
[ 4 ]
346
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
null
Migraine
null
2
arm 1: Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate arm 2: matching placebo
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack. intervention 2: One dose matching placebo to Rizatriptan to treat one migraine attack.
intervention 1: Comparator: Rizatriptan intervention 2: Comparator: Placebo
0
null
297
0
0
0
NCT00250458
1COMPLETED
2006-10-01
2006-03-01
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
[ 3 ]
131
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
This is a multicenter, randomized study of IL-12p40 (CNTO 1275), hereafter referred to as ustekinumab, in 2 populations of participants with moderately to severely active Crohn's disease of at least 6 weeks duration. A total of approximately 120 volunteers will participate in this study in Canada, Belgium, and the Unit...
Crohn Disease
Crohn Disease Biologic Infusion Injection CNTO 1275 Ustekinumab C01275 IL-12p40
null
6
arm 1: Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. arm 2: Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention P...
[ 0, 0, 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: one 90 mg SC injection each week for 4 weeks (Weeks 0-3 during Intervention Period 1 or Weeks 8-11 during Intervention Period 2 for Population 1 or Weeks 0-3 during Intervention Period 1 for Population 2) intervention 2: one IV infusion of 4.5 mg/kg over a period of not less than 2 hours at Week 0 in In...
intervention 1: Ustekinumab 90 mg intervention 2: Ustekinumab 4.5 mg/kg intervention 3: Placebo SC intervention 4: Placebo IV
57
Scottsdale | Arizona | United States | -111.89903 | 33.50921 Anaheim | California | United States | -117.9145 | 33.83529 Sacramento | California | United States | -121.4944 | 38.58157 San Francisco | California | United States | -122.41942 | 37.77493 Bristol | Connecticut | United States | -72.94927 | 41.67176 New Have...
120
0
0
0
NCT00265122
1COMPLETED
2006-10-01
2004-04-01
Centocor, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
24
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This study evaluates the safety of infliximab in infants and children with acute Kawasaki Disease.
This study is an exploratory, pilot study to examine tolerance and pharmacokinetics of infliximab in infants and children with acute Kawasaki Disease.
Kawasaki Disease
null
2
arm 1: Subjects who did not respond to the first dose of IVIG received a 2nd dose of IVIG in this arm (2g/kg) arm 2: Remicade (5mg/kg) single dose
[ 1, 0 ]
2
[ 0, 2 ]
intervention 1: Remicade was 5 mg/kg IV (single dose) intervention 2: 2nd dose of IVIG (2g/kg)
intervention 1: Infliximab (Remicade) intervention 2: Intravenous immunoglobulin (IVIG)
1
San Diego | California | United States | -117.16472 | 32.71571
24
0
0
0
NCT00271570
1COMPLETED
2006-10-01
2004-04-01
University of California, San Diego
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 ]
130
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this trial is to assess whether rotigotine has an effect on the electrical activity of the heart. Moxifloxacin infusion is used as positive control to assess assay sensitivity.
null
Parkinson's Disease
advanced-stage idiopathic Parkinson's disease
null
2
arm 1: Rotigotine Patch arm 2: Placebo patch
[ 0, 2 ]
5
[ 0, 10, 0, 10, 10 ]
intervention 1: Rotigotine patch applied once daily for a 24-hour period. Rotigotine dose schedule (patch application days): Day 1 through Day 7: 9.0 mg/day; Day 8 through Day 14: 18.0 mg/day; Day 15 through Day 21: 27.0 mg/day; Day 22 through Day 28: 36.0 mg/day; Day 29 through Day 35: 45.0 mg/day; Day 36 through Da...
intervention 1: Rotigotine intervention 2: Placebo intervention 3: Moxifloxacin infusion intervention 4: Placebo infusion intervention 5: Placebo infusion
2
Bloemfontein | N/A | South Africa | 26.214 | -29.12107 George | N/A | South Africa | 22.46173 | -33.963
130
0
0
0
NCT00292227
1COMPLETED
2006-10-01
2006-01-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
418
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
null
Rhinitis, Allergic, Seasonal
Levocetirizine Xyzal Rhinitis Allergic Seasonal Ragweed
null
3
arm 1: Placebo was administered orally on Days 1 and 2. arm 2: 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. arm 3: 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: * Pharmaceutical form: Over-encapsulated tablet * Route of administration: Oral use intervention 2: * Pharmaceutical form: Over-encapsulated tablet * Concentration: 10 mg * Route of administration: Oral use intervention 3: * Pharmaceutical form: Over-encapsulated tablet * Concentration: 5 mg * Route of ...
intervention 1: Placebo intervention 2: Montelukast intervention 3: Levocetirizine
1
Kingston | Ontario | Canada | -76.48098 | 44.22976
418
0
0
0
NCT00295022
1COMPLETED
2006-10-01
2006-07-29
UCB S.A. - Pharma Sector
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
296
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
To evaluate the safety and efficacy of 8 weeks of treatment with MN-001 at 500 mg bid, 500 mg once daily vs. placebo in patients with Interstitial Cystitis.
This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of two dosing regimens of MN-001 in patients with Interstitial Cystitis (IC). Patients will be screened for study eligibility within seven to nine days of randomization. Eligible patients will be randomized in...
Interstitial Cystitis
Interstitial Cystitis urgency frequency MN-001 Global Response Assessment bladder pain/urgency O'Leary Sant IC Symptom and Problem Index
null
2
arm 1: None arm 2: placebo tablets
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Eligible patients received 500 mg MN-001 bid intervention 2: Eligible patients received 500 mg MN-001 once daily (qd) intervention 3: Eligible patients received placebo
intervention 1: MN-001 BID intervention 2: MN-001 intervention 3: Placebo
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Glendora | California | United States | -117.86534 | 34.13612 Long Beach | California | United States | -118.18923 | 33.76696 San Diego | California | United States | -117.16472 | 32.71571 Boulder | Colorado | United States | -105.27055 | 40.01499 Wheat Ridge ...
296
0
0
0
NCT00295854
1COMPLETED
2006-10-01
2005-05-01
MediciNova
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 ]
857
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to compare the efficacy and safety of pitavastatin with that of simvastatin.
null
Hypercholesterolemia Dyslipidemia
hypercholesterolemia kowa dyslipidemia pitavastatin NK-104 Primary Hypercholesterolemia or Combined Dyslipidemia
null
4
arm 1: Pitavastatin 2 mg once daily arm 2: Simvastatin 20 mg once daily arm 3: Pitavastatin 4 mg once daily arm 4: Simvastatn 40 mg once daily
[ 0, 1, 0, 1 ]
2
[ 0, 0 ]
intervention 1: Pitavastatin once daily intervention 2: Simvastatin once daily
intervention 1: Pitavastatin intervention 2: Simvastatin
42
Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Helsinki | N/A | Finland | 24.93545 | 60.16952 Tampere | N/A | Finland | 23.78712 | 61.49911 Turku | N/A | Finland | 22.26869 | 60.45148 Bologna | N/A | Italy | 11.33875 | 44.49381 Chieti | N/A | Italy | 14.16494 | 42.34827 Fe...
848
0
0
0
NCT00309777
1COMPLETED
2006-10-01
2005-09-01
Kowa Research Europe
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 ]
22
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe 10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian population with primary hypercholesterolemia.
null
Hypercholesterolemia Coronary Arteriosclerosis
null
2
arm 1: Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin. arm 2: Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin intervention 2: 10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin intervention 3: 10 mg/day atorvastatin, orally, (ongoing treatment in participants)
intervention 1: Ezetimibe intervention 2: Placebo intervention 3: Atorvastatin 10 mg
0
null
22
0
0
0
NCT00319449
1COMPLETED
2006-10-01
2005-09-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
201
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
null
Pain, Postoperative
Bunionectomy Bunion surgery Post-operative pain
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 25 mg every 6 hours intervention 2: Placebo every 6 hours
intervention 1: diclofenac potassium (XP21L) intervention 2: Placebo
6
Anaheim | California | United States | -117.9145 | 33.83529 Orange | California | United States | -117.85311 | 33.78779 Owings Mills | Maryland | United States | -76.78025 | 39.41955 Pasadena | Maryland | United States | -76.57108 | 39.119 Altoona | Pennsylvania | United States | -78.39474 | 40.51868 Salt Lake City | U...
201
0
0
0
NCT00366444
1COMPLETED
2006-10-01
2006-08-01
Xanodyne 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 ]
8
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
Phase 1 Open-label treatment with MPC-2130 for subjects with refractory cancer.
MPC-2130 Phase 1 Clinical study was designed to evaluate its safety and pharmacokinetic profile in patients with advanced metastatic tumors or blood cancers as well as refractory cancers that progressed despite previous chemotherapy.
Cancer
Oncology Cancer Blood Cancers
null
0
null
null
1
[ 0 ]
intervention 1: MPC-2130 10 mg/mL administered by intravenous infusion over 1-2 hours
intervention 1: MPC-2130
1
Houston | Texas | United States | -95.36327 | 29.76328
8
0
0
0
NCT00387153
6TERMINATED
2006-10-01
2005-08-01
Myriad 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
[ 3 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.
This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, ...
Coronary Artery Disease Angina, Unstable
Argatroban Direct thrombin inhibitor Percutaneous coronary intervention Activated clotting time PCI ACT
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None
intervention 1: Argatroban intervention 2: Argatroban intervention 3: Argatroban intervention 4: Heparin
8
Aalst | N/A | Belgium | 4.0355 | 50.93604 Bad Nauheim | N/A | Germany | 8.73859 | 50.36463 Cologne | N/A | Germany | 6.95 | 50.93333 Dachau | N/A | Germany | 11.43402 | 48.26 Düren | N/A | Germany | 6.49299 | 50.80434 Frankfurt | N/A | Germany | 10.53333 | 49.68333 Halle | N/A | Germany | 11.97947 | 51.48158 Mainz | N/...
140
0
0
0
NCT00508924
1COMPLETED
2006-10-01
2005-08-01
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
[ 2 ]
56
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study is being conducted to determine what dexmedetomidine does to the body and in turn, what how the body handles the medication. This medication, for the purpose of this trial, is used as a short-term sedative for infants who are immediately post-operative from cardiac surgery and have a breathing tube and are b...
This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in infants who are immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus doses and...
Hypoplastic Left Heart Tetralogy of Fallot Tricuspid Atresia
Postoperative from cardiac surgery Dexmedetomidine
null
1
arm 1: A predetermined dose of Dexmedetomidine
[ 0 ]
1
[ 0 ]
intervention 1: Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
intervention 1: Dexmedetomidine
0
null
56
0
0
0
NCT00573066
1COMPLETED
2006-10-01
2004-05-01
Athena Zuppa
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 ]
246
RANDOMIZED
PARALLEL
4SUPPORTIVE_CARE
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day base...
Pain Peripheral Neuropathy
Pain Peripheral Neuropathy Allodynia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours intervention 2: containing peppermint oil, 0.05% (v/...
intervention 1: Sativex intervention 2: Placebo
1
Glasgow | West Lothain | United Kingdom | -4.25763 | 55.86515
246
0
0
0
NCT00710554
1COMPLETED
2006-10-01
2005-08-01
Jazz Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
32
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this study is to assess the efficacy (bronchoprotection) and safety of single doses of BI 1744 CL inhalation solution (2, 5, 10 and 20 mcg) delivered via the Respimat® inhaler, in patients with intermittent asthma.
null
Asthma
null
5
arm 1: Single dosing of low dose Olodaterol inhaled orally from Respimat Device arm 2: Single dosing of medium low dose Olodaterol inhaled orally from Respimat Device arm 3: Single dosing of medium high dose Olodaterol inhaled orally from Respimat Device arm 4: Single dosing of high dose Olodaterol inhaled orally from ...
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Placebo device for comparison intervention 2: Olodaterol comparison of low, medium low, medium high and high doses intervention 3: Olodaterol comparison of low, medium low, medium high and high doses intervention 4: Olodaterol comparison of low, medium low, medium high and high doses intervention 5: Olo...
intervention 1: Placebo intervention 2: Olodaterol (BI1744CL) intervention 3: Olodaterol (BI1744CL) intervention 4: Olodaterol (BI1744CL) intervention 5: Olodaterol (BI1744CL)
4
Vancouver | British Columbia | Canada | -123.11934 | 49.24966 Hamilton | Ontario | Canada | -79.84963 | 43.25011 Sainte-Foy | Quebec | Canada | -71.29217 | 46.78139 Saskatoon | Saskatchewan | Canada | -106.66892 | 52.13238
144
0
0
0
NCT00928668
1COMPLETED
2006-10-01
2006-01-01
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 ]
61
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and tolerability of subcutaneous (SC) or intramuscular (IM) recombinant human erythropoietin beta (r-HuEPO) in participants with anemia and histologically or cytologically confirmed cancer.
null
Anemia
null
1
arm 1: Anemic cancer participants will receive r-HuEPO for 4 weeks.
[ 0 ]
1
[ 0 ]
intervention 1: All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days...
intervention 1: r-HuEPO
7
Bari | N/A | Italy | 16.86982 | 41.12066 Benevento | N/A | Italy | 14.77816 | 41.1307 Cagliari | N/A | Italy | 9.11917 | 39.23054 Campobasso | N/A | Italy | 14.66737 | 41.55947 Napoli | N/A | Italy | 14.5195 | 40.87618 Palermo | N/A | Italy | 13.3636 | 38.1166 Palermo | N/A | Italy | 13.3636 | 38.1166
61
0
0
0
NCT02767765
1COMPLETED
2006-10-01
2003-06-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0