FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 3 ]
8
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
false
This study will evaluate the efficacy and tolerability of the combination of Gleevec and Gemzar in patients with ovarian cancer, who have progressed after receiving at least one prior chemotherapy treatment. Gleevec is an oral chemotherapy drug used is this study and Gemzar is an IV chemotherapy drug used. Participatio...
Each 21 day period will be considered a cycle. Disease status will be assessed with a Cancer Antigen (CA)-125 prior to the start of each new cycle with an assessment of measurable diseased by either CT or MRI every 6 weeks. Treatment will continue until disease progression, unacceptable toxicities, or the patient elect...
Ovarian Cancer Primary Peritoneal Cancer
ovarian cancer peritoneal endometrioid mucinous serous clear cell
null
1
arm 1: All research subjects receive oral imatinib 400mg days 1-5 and 8-12 of a 21 day cycle. All research subjects received IV gemcitabine 1000mg/m2 days 3 and 10 of a 21-day cycle. . All subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis and had failed to respond to prior chemotherapy or pr...
[ 0 ]
2
[ 0, 0 ]
intervention 1: imatinib mesylate - 400mg orally, daily on Days 1-5 and 8-12 of a 21 day cycle. intervention 2: Gemcitabine - 1000 mg/m2 IV on Day 3 and Day 10 of a 21 day cycle
intervention 1: imatinib mesylate by mouth intervention 2: Gemcitabine Intravenous
1
Tacoma | Washington | United States | -122.44429 | 47.25288
8
0
0
0
NCT00928642
1COMPLETED
2010-11-01
2009-06-01
Henry M. Jackson Foundation for the Advancement of Military Medicine
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 ]
356
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine if lithium 600-1800 mg/day is effective when added to quetiapine fumarate extended release (quetiapine XR or SEROQUEL® XR) 400-800 mg/day in treating acute mania and if so, how it compares with placebo (a non-active capsule, like a sugar pill, that looks like lithium).
null
Acute Mania
Acute Mania Mania, Adults Seroquel Acute Mania in Adult Patients
null
2
arm 1: Seroquel XR and Lithium arm 2: Seroquel XR and placebo
[ 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator. intervention 2: Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the di...
intervention 1: Quetiapine fumarate XR intervention 2: Lithium intervention 3: Placebo
65
Montignies-sur-Sambre | Belgium | Belgium | 4.49109 | 50.41081 Overpelt | Belgium | Belgium | 5.41557 | 51.21038 Cedex | Cedex | Belgium | N/A | N/A Dendermonde | N/A | Belgium | 4.10106 | 51.02869 Tournai | N/A | Belgium | 3.38932 | 50.60715 Burgas | Bulgaria | Bulgaria | 27.46781 | 42.50606 Radnevo | Bulgaria | Bulga...
356
0
0
0
NCT00931723
1COMPLETED
2010-11-01
2009-06-01
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
[ 5 ]
15
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or...
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
2
[ 0, 0 ]
intervention 1: 1000mg iv on days 1 and 15 intervention 2: 10-25mg weekly
intervention 1: rituximab [MabThera/Rituxan] intervention 2: methotrexate
5
Casablanca | N/A | Morocco | -7.61138 | 33.58831 Casablanca | N/A | Morocco | -7.61138 | 33.58831 Marrakesh | N/A | Morocco | -7.99994 | 31.63416 Rabat | N/A | Morocco | -6.83255 | 34.01325 Salé | N/A | Morocco | -6.79846 | 34.0531
15
0
0
0
NCT00934648
1COMPLETED
2010-11-01
2007-10-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
87
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this study is to investigate if 28 days of treatment with AZD2066 compared to placebo can relieve the pain arising from the nervous system when the patients are touched by something that should not cause pain or have severe pain when they are touched by something that should only cause a little pain.
null
Neuropathic Pain Mechanical Hypersensitivity
Pain, Mechanical Hypersensitivity Allodynia Efficacy analgesia Neuropathic
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Capsule, once daily intervention 2: Capsule, once daily
intervention 1: AZD2066 intervention 2: Placebo
38
Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Sacramento | California | United States | -121.4944 | 38.58157 San Francisco | California | United States | -122.41942 | 37.77493 Walnut Creek | California | United States | -122.06496 | 37.90631 Bo...
86
0
0
0
NCT00939094
6TERMINATED
2010-11-01
2009-08-01
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
[ 3 ]
106
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
Study to evaluate the safety, tolerability and efficacy of LY2189102 in patients with type 2 diabetes.
null
Type 2 Diabetes
Diabetes Type 2 Diabetes
null
4
arm 1: None arm 2: None arm 3: None arm 4: 0.9% Sodium Chloride
[ 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants received 2 subcutaneous (SC) injections weekly for 12 weeks. intervention 2: Participants received 2 SC injections weekly for 12 weeks.
intervention 1: LY2189102 intervention 2: Placebo
18
Mobile | Alabama | United States | -88.04305 | 30.69436 Anaheim | California | United States | -117.9145 | 33.83529 Chula Vista | California | United States | -117.0842 | 32.64005 La Mesa | California | United States | -117.02308 | 32.76783 Walnut Creek | California | United States | -122.06496 | 37.90631 Washington D....
106
0
0
0
NCT00942188
1COMPLETED
2010-11-01
2009-06-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
48
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
true
This study will demonstrate the behavioral responses to varenicline, helping to better understand its mechanisms. Hypotheses for the study are to observe decreases in smoking topography and nicotine cigarette choice on varenicline, relative to placebo; and decreases on day 21 relative to day 7 during varenicline treatm...
This study is designed to examine the behavioral responses a cigarette smoker may have to using varenicline. Behavioral responses may help to better understand its mechanisms which in turn could improve treatment outcomes. The primary hypothesis for the study is to observe decreases in smoking topography, an objective ...
Nicotine Dependence
smoking nicotine varenicline
null
2
arm 1: Drug (Varenicline (Chantix)): Placebo Intervention to be administered is: participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21. arm 2: Placebo: Drug Varen...
[ 0, 0 ]
1
[ 0 ]
intervention 1: Intervention Drug (Varenicline (Chantix) will be administered in standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21.
intervention 1: Varenicline
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
29
0
0
0
NCT00948155
1COMPLETED
2010-11-01
2009-01-01
University of Pennsylvania
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 ]
308
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The main purpose of this study is to determine if 30 milligrams (mg) of duloxetine is effective in the treatment of fibromyalgia compared to placebo.
null
Fibromyalgia, Primary Fibromyalgia, Secondary
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks intervention 2: QD po at the same time each day for 12 weeks
intervention 1: Duloxetine intervention 2: Placebo
4
Guadalajara | N/A | Mexico | -103.34749 | 20.67738 Mérida | N/A | Mexico | -89.62318 | 20.967 Monterrey | N/A | Mexico | -100.31721 | 25.68435 Morelia | N/A | Mexico | -101.18443 | 19.70078
325
0
0
0
NCT00965081
1COMPLETED
2010-11-01
2009-09-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemother...
Despite advances in the treatment of head and neck cancer, locoregional recurrences are the predominant site of treatment failure and are frequently the cause of death. Second primary tumors in the head and neck occur in up to 30% of patients at 10 years of follow-up after eradication of the original tumor due to field...
Cancer of the Pharynx Cancer of the Larynx Cancer of the Neck Paranasal Sinus Neoplasms Cancer of the Head
celecoxib erlotinib epidermal growth factor receptor intensity-modulated radiotherapy cyclooxygenase-2 reirradiation
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be giv...
intervention 1: erlotinib + celecoxib
1
New York | New York | United States | -74.00597 | 40.71427
14
0
0
0
NCT00970502
1COMPLETED
2010-11-01
2007-02-01
Johnny Kao
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 ]
35
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
true
Background: * Niemann-Pick disease type C (NPC) is a genetic disorder that results in progressive loss of nervous system function by affecting the membranes of nerve cells. There is no known cure for NPC. * N-acetyl cysteine (NAC) is a drug that has been approved by the Food and Drug Administration to use either orall...
Niemann-Pick Disease, type C (NPC) is an autosomal recessive lysosomal storage disease with progressive neurodegeneration. It is characterized by intracellular accumulation of cholesterol and glycosphingolipids. The age of onset is variable with cases manifesting from infancy to adulthood. Classically, initial neurolog...
Niemann-Pick Disease, Type C
Niemann-Pick Disease, Type C Biomarkers N-Acetyl Cysteine Oxidized Cholesterol Neurodegeneration NPC
null
0
null
null
1
[ 0 ]
intervention 1: 900mg effervescent tablet; Dosed as 15 mg/kg/day (maximum dose 900 mg per day) for one week, advanced to 30 mg/kg/day (maximum dose 1800 mg per day) for the second week, and then advanced to 60 mg/kg/day (maximum dose 2700 mg) for the remainder of the trial (6 additional weeks).
intervention 1: N-Acetyl Cysteine
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
35
0
0
0
NCT00975689
1COMPLETED
2010-11-01
2009-08-01
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
154
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
2DOUBLE
false
0ALL
false
The purpose of this study is to evaluate the effects of dapagliflozin on kidney function, as assessed by glomerular filtration rate.
null
Type 2 Diabetes Mellitus
null
2
arm 1: None arm 2: None
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Tablets, Oral, 10 mg, once daily, 12 weeks intervention 2: Tablets, Oral, 0 mg, once daily, 12 weeks intervention 3: Tablets, Oral, 25 mg, once daily, 12 weeks
intervention 1: Dapagliflozin intervention 2: Placebo intervention 3: Hydrochlorothiazide
12
Anaheim | California | United States | -117.9145 | 33.83529 Lomita | California | United States | -118.31507 | 33.79224 Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Orlando | Florida | United States | -81.37924 | 28.53834 Ann Arbor | Michigan | United S...
75
0
0
0
NCT00976495
1COMPLETED
2010-11-01
2009-10-01
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
[ 0 ]
216
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
true
Staphylococcus aureus, a bacteria that lives commonly in the anterior nostrils, is seen in about 30% of healthcare workers. Applying mupirocin ointment, a prescription, to the nostrils twice daily for 5 days is the current standard of care for treatment to clear this bacteria. This research study is designed to determi...
null
Nasal Carriers of Staphylococcus Aureus
healthcare staphylococcus aureus nasal
null
0
null
null
1
[ 0 ]
intervention 1: 2 1/32oz packages will be dispensed. If positive nasal swab for S. aureus, subjects will apply a small amount to anterior nares twice daily for 5 days.
intervention 1: Neosporin (polymyxin B 5,000units, bacitracin 400 units, neomycin 3.5mg)
1
Chicago | Illinois | United States | -87.65005 | 41.85003
216
0
0
0
NCT00997139
1COMPLETED
2010-11-01
2009-09-01
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
[ 4 ]
828
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.
null
Chronic Obstructive Pulmonary Disease (COPD)
Chronic Obstructive Pulmonary Disease antimuscarinic COPD
null
3
arm 1: Aclidinium bromide 200 μg twice-daily via inhalation arm 2: Aclidinium bromide 400 μg twice-daily via inhalation arm 3: Placebo
[ 0, 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Aclidinium bromide 200 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 2: Aclidinium bromide 400 μg twice-daily via inhalation by the Eklira Genuair® inhaler: 1 puff in the morning and evening for 24 weeks intervention 3: Placebo ...
intervention 1: Aclidinium bromide 200 μg bid intervention 2: Aclidinium bromide 400 μg bid intervention 3: Placebo
106
Benešov | N/A | Czechia | 14.68697 | 49.78162 Jaroměř | N/A | Czechia | 15.92136 | 50.3562 Liberec | N/A | Czechia | 15.05619 | 50.76711 Lovosice | N/A | Czechia | 14.05103 | 50.51504 Neratovice | N/A | Czechia | 14.51759 | 50.25926 Prague | N/A | Czechia | 14.42076 | 50.08804 Prague | N/A | Czechia | 14.42076 | 50.088...
819
0
0
0
NCT01001494
1COMPLETED
2010-11-01
2009-10-01
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
[ 3 ]
95
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
Histaminergic agents are known to be involved with the sleep/wake cycle. This compound is a histaminergic agent which therefore may improve alertness and awakeness in patients with excessive daytime sleepiness (EDS) associated with narcolepsy. Significant improvement in EDS when treated with this compound compared to p...
null
Excessive Daytime Sleepiness Narcolepsy
Randomized double-blind placebo-controlled crossover study of PF-03654746 in Excessive Daytime Sleepiness associated with Narcolepsy
null
2
arm 1: None arm 2: At the end of the second arm of the study, the patient will have completed the study and have a 7-10 day follow-up visit.
[ 2, 1 ]
2
[ 0, 0 ]
intervention 1: Patients receiving placebo will undergo the same procedures as those receiving active treatment. Each patient will receive matching placebo tablets in a fixed dose escalation schedule beginning at 0.25 mg QD for 5 days; then up to 0.50 mg QD for another 5 days; and up to 1.0 mg QD for an additional 5 da...
intervention 1: Placebo intervention 2: PF-03654746
21
Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 Brandon | Florida | Un...
157
0
0
0
NCT01006122
1COMPLETED
2010-11-01
2009-11-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 5 ]
36
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
In subjects on boosted protease inhibitor (PI)-regimens who have elevated triglycerides, a switch to fosamprenavir/ritonavir once daily followed by the addition of Lovaza will result in 30% of patients achieving a reduction in fasting triglycerides \< 200 mg /dL while maintaining virologic suppression.
null
Hypertriglyceridemia HIV Infection
HIV triglycerides fosamprenavir
null
1
arm 1: None
[ 0 ]
2
[ 7, 0 ]
intervention 1: Lovaza at a dose of 4g per day with each 1g capsule containing 465 mg of eicosapentaenoic acid (EPA) and 375 mg of docosahexaenoic acid (DHA) for 18 weeks intervention 2: Lexiva (fosamprenavir calcium) 1400 mg per day, Norvir (ritonavir) 100 mg per day
intervention 1: Lovaza intervention 2: fosamprenavir/ritonavir
1
Bakersfield | California | United States | -119.01871 | 35.37329
36
0
0
0
NCT01010399
1COMPLETED
2010-11-01
2009-09-01
Felizarta, Franco, M.D.
3INDIV
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
744
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply ...
Acne Vulgaris
Ance
null
2
arm 1: Tazarotene foam, 0.1% arm 2: Vehicle Foam
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tazarotene foam once a day application to the face intervention 2: Vehicle Foam once a day application to the face
intervention 1: Tazarotene foam intervention 2: Vehicle Foam
22
Denver | Colorado | United States | -104.9847 | 39.73915 Miami Beach | Florida | United States | -80.13005 | 25.79065 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Fridley | Minnesota | United States | -93.26328 | 45.08608 Albuquerque | New Mexico | United States | -106.65114 | 35.08449 Stony Brook | Ne...
743
0
0
0
NCT01017146
1COMPLETED
2010-11-01
2009-10-01
Stiefel, a GSK Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
200
RANDOMIZED
PARALLEL
1PREVENTION
2DOUBLE
false
0ALL
false
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecy...
null
Postoperative Nausea
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 3, 0 ]
intervention 1: 40 mg po pre-op intervention 2: Orally, pre-op
intervention 1: Aprepitant intervention 2: Placebo
1
Staten Island | New York | United States | -74.13986 | 40.56233
0
0
0
0
NCT01020903
1COMPLETED
2010-11-01
2009-11-01
Northwell Health
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
440
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood glucose lowering effect and the safety profile of repaglinide given alone compared to gliclazide given alone in Chinese subjects with type 2 diabetes who never have been treated with oral anti-diabetic drugs (OADs). This study a...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: 1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily arm 2: 80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Individually adjusted dose for 16 weeks intervention 2: Individually adjusted dose for 16 weeks
intervention 1: repaglinide intervention 2: gliclazide
1
Shanghai | Shanghai Municipality | China | 121.45806 | 31.22222
435
0
0
0
NCT01022762
1COMPLETED
2010-11-01
2009-11-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,071
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to compare the antihypertensive effect of azilsartan medoxomil plus chlorthalidone, once daily (QD), to olmesartan medoxomil plus hydrochlorothiazide in participants with moderate to severe hypertension.
According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. As the population ages, the prevalence of hypertension ...
Essential Hypertension
Hypertensive Blood Pressure, High Cardiovascular disease Vascular Disease Drug Therapy
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks. Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg com...
intervention 1: Azilsartan medoxomil and chlorthalidone intervention 2: Azilsartan medoxomil and chlorthalidone intervention 3: Olmesartan medoxomil and hydrochlorothiazide
94
Gulf Shores | Alabama | United States | -87.70082 | 30.24604 Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Mesa | Arizona | United States | -111.82264 | 33.42227 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Buena Park | Califor...
1,071
0
0
0
NCT01033071
1COMPLETED
2010-11-01
2010-01-01
Takeda
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 ]
458
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial will be conducted in Africa, Asia, North America and South America. The aim of this clinical trial is to compare NN1250 (insulin degludec) with sitagliptin, as add-on to subject's own current oral antidiabetic (OAD) treatment, in subjects with type 2 diabetes inadequately controlled with 1-2 OADs (metformin,...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Injected under the skin once daily for 26 weeks. The doses will be individually adjusted. intervention 2: Sitagliptin tablets administered orally once a day at the same time every day for 26 weeks
intervention 1: insulin degludec intervention 2: sitagliptin
93
Huntsville | Alabama | United States | -86.58594 | 34.7304 Concord | California | United States | -122.03107 | 37.97798 Fresno | California | United States | -119.77237 | 36.74773 Greenbrae | California | United States | -122.5247 | 37.94854 La Jolla | California | United States | -117.2742 | 32.84727 Long Beach | Cali...
454
0
0
0
NCT01046110
1COMPLETED
2010-11-01
2010-01-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
10
RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
To determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light...
Subjects will be randomized such that their RIGHT dorsal hand/forearm will receive one of the following two treatments with the subject's LEFT dorsal hand/forearm receiving the other treatment; Treatment 1 will include pre-treatment of the dorsal hand/forearm with Tazorac 0.1% gel BID for one week, followed by ALA appl...
ACTINIC KERATOSES
ACTINIC KERATOSES HAND FOREARM
null
2
arm 1: Apply Tazorac 0.1% gel for 1 week to the Left arm only and then receive ALA- PDT Treatment to both arms arm 2: Apply Tazorac 0.1% gel for 1 week to the Right arm only and then receive ALA- PDT Treatment to both arms
[ 0, 0 ]
1
[ 0 ]
intervention 1: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment with Tazorac vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, usin...
intervention 1: Tazorac
1
Fort Lauderdale | Florida | United States | -80.14338 | 26.12231
20
0
0
0
NCT01053000
1COMPLETED
2010-11-01
2010-01-01
Stewart, Roger H., M.D., P.A.
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 ]
52
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of the study is to evaluate structural changes effected by AD9668 in the airways of adults with Chronic Obstructive Pulmonary Disease (COPD) by Multi-Slice Computed Tomography (MSCT)
null
Chronic Obstructive Pulmonary Disease (COPD)
Chronic obstructive pulmonary lung respiratory disease efficacy placebo-controlled COPD FEV1 St Georges Respiratory Questionnaire Computed Tomography MSCT
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 x 30 mg oral tablets twice daily (bid) for 12 weeks intervention 2: 2 x matched placebo to oral tablet twice daily (bid) for 12 weeks
intervention 1: AZD9668 intervention 2: Placebo
9
Kingston | Ontario | Canada | -76.48098 | 44.22976 Québec | Quebec | Canada | -71.21454 | 46.81228 Hellerup | N/A | Denmark | 12.57093 | 55.73204 Hvidovre | N/A | Denmark | 12.47708 | 55.64297 Odensec | N/A | Denmark | N/A | N/A Breda | N/A | Netherlands | 4.77596 | 51.58656 Nieuwegein | N/A | Netherlands | 5.08056 | 5...
52
0
0
0
NCT01054170
1COMPLETED
2010-11-01
2010-01-01
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
[ 3 ]
111
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
All patients will be in instructed to eat a therapeutic lifestyle diet and will receive CP-690,550 throughout the 12 weeks of this study. After 6 weeks, half will receive the cholesterol lowering agent, atorvastatin, and half a matching placebo. This study will first measure the effects of CP-690,550 on cholesterol lev...
null
Rheumatoid Arthritis
cholesterol lipids rheumatoid arthritis CP-690 550
null
2
arm 1: None arm 2: None
[ 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 12 week open-label CP-690,550 10 mg oral tablets administered twice daily starting at Day 0 through Week 12 intervention 2: Starting at Week 6 and continuing through Week 12 atorvastatin 10 mg oral tablets administered once daily intervention 3: 12 week open-label CP-690,550 10 mg oral tablets administe...
intervention 1: CP-690,550 intervention 2: Atorvastatin intervention 3: CP-690,550 intervention 4: Atorvastatin Placebo
15
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Gilbert | Arizona | United States | -111.78903 | 33.35283 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Upland | California | United States | -117.64839 | 34.09751 Jacksonville | Florida...
208
0
0
0
NCT01059864
1COMPLETED
2010-11-01
2010-02-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
While the repair of the epidermal barrier in atopic dermatitis is of major importance in the treatment of atopic dermatitis, most of the vehicles used may actually cause a worsening of an impaired epidermal barrier. Hydrogel vehicle is anecdotally known to be moisturizing and hydrating.This study will compare the use o...
null
Atopic Dermatitis
Transepidermal water loss Epidermal barrier Skin hydration
null
2
arm 1: Parallel designed study. Split body treatment arm 2: Parallel study design. Split body study.
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Each morning and evening, gently wash the target area with warm water and gently pat dry with soft towel. Once dry place a small amount of Hydrogel vehicle onto the tip of your finger. Place a dab of the Hydrogel vehicle on either the left or right side of the body as instructed. (Do not use Hydrogel ve...
intervention 1: Hydrogel vehicle intervention 2: Eucerin Lotion
1
Louisville | Kentucky | United States | -85.75941 | 38.25424
20
0
0
0
NCT01065714
1COMPLETED
2010-11-01
2010-02-01
Derm Research, PLLC
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 ]
460
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in South Africa, Europe and North America. The aim of this trial is to compare efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar), as add-on to subject's ongoing treatment with metformin and/or dipeptyl peptidase 4 (DPP-4) inhibitors, in patients with type 2 di...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
intervention 1: insulin degludec intervention 2: insulin glargine
116
Huntsville | Alabama | United States | -86.58594 | 34.7304 Gilbert | Arizona | United States | -111.78903 | 33.35283 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Anaheim | California | United States | -117.9145 | 33.83529 Huntington Beach | Californi...
456
0
0
0
NCT01068665
1COMPLETED
2010-11-01
2010-03-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
460
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Africa, Asia, Europe, and North America. The aim of this clinical trial is to compare the efficacy and safety of NN1250 (insulin degludec (IDeg)) with insulin glargine (IGlar) in subjects with type 2 diabetes currently treated with metformin alone or with metformin combined with an oral anti-...
null
Diabetes Diabetes Mellitus, Type 2
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted. intervention 2: Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
intervention 1: insulin degludec intervention 2: insulin glargine
99
Northridge | California | United States | -118.53675 | 34.22834 Palm Springs | California | United States | -116.54529 | 33.8303 Paramount | California | United States | -118.15979 | 33.88946 Santa Ana | California | United States | -117.86783 | 33.74557 Spring Valley | California | United States | -116.99892 | 32.7447...
456
0
0
0
NCT01068678
1COMPLETED
2010-11-01
2010-02-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
216
RANDOMIZED
SINGLE_GROUP
0TREATMENT
1SINGLE
false
0ALL
null
Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease
Evaluate the safety and efficacy of paricalcitol injection with two different dosing regimens (currently approved dosing regimen used in the US package insert versus dosing based on a formula of iPTH/80 that was approved and used in the EU package insert) in Chronic Kidney Disease (CKD) Stage 5 subjects with secondary ...
Chronic Kidney Disease
Chronic Kidney Disease Secondary hyperparathyroidism
null
2
arm 1: Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL). arm 2: Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
[ 1, 1 ]
1
[ 0 ]
intervention 1: Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
intervention 1: paricalcitol
12
Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Dalian | N/A | China | 121.60222 | 38.91222 Guangzhou | N/A | China | 113.25 | 23.11667 Nanjing | N/A | China | 118.77778 | 32.06167 Qingdao | N/A | China | 120.38042 | 36.06488 Shanghai |...
216
0
0
0
NCT01071070
1COMPLETED
2010-11-01
2009-11-01
Abbott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
154
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patient...
There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts abou...
Hyperphosphatemia End-Stage Renal Disease
Hyperphosphatemia ESRD Dialysis End Stage Renal Disease Phosphorus Renal Kidney
null
3
arm 1: 1 g/day KRX-0502 (ferric citrate) arm 2: 6 g/day KRX-0502 (ferric citrate) arm 3: 8 g/day KRX-0502 (ferric citrate)
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
intervention 1: ferric citrate
16
Westminster | Colorado | United States | -105.0372 | 39.83665 Pembroke Pines | Florida | United States | -80.22394 | 26.00315 Augusta | Georgia | United States | -81.97484 | 33.47097 Chicago | Illinois | United States | -87.65005 | 41.85003 Springfield | Massachusetts | United States | -72.58981 | 42.10148 Brooklyn | N...
151
0
0
0
NCT01074125
1COMPLETED
2010-11-01
2010-05-01
Keryx Biopharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
31
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.
null
Hypertension Ankle Edema
Pedal edema hypertension aliskiren amlodipine
null
2
arm 1: During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule o...
[ 0, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Aliskiren/amlodipine 150/5 mg/day intervention 2: Amlodipine 5 mg/day. intervention 3: Placebo to Aliskiren/amlodipine 150/10 mg/day intervention 4: Placebo to Amlodipine 5 mg/day
intervention 1: Aliskiren/amlodipine intervention 2: Amlodipine intervention 3: Placebo to Aliskiren/amlodipine intervention 4: Placebo to Amlodipine
9
Beek en Donk | N/A | Netherlands | 5.62603 | 51.54158 Bosch | N/A | Netherlands | 5.59167 | 51.27 Hoogwoud | N/A | Netherlands | 4.93889 | 52.71583 Lichtenvoorde | N/A | Netherlands | 6.56667 | 51.98667 Lieshout | N/A | Netherlands | 5.59479 | 51.52036 Poortvliet | N/A | Netherlands | 4.14306 | 51.54417 The Hague | N/A...
31
0
0
0
NCT01080768
6TERMINATED
2010-11-01
2010-02-01
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
137
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to demonstrate that treatment with OXN PR tablets is non inferior to treatment with OXY PR tablets in terms of analgesic efficacy in patients with postoperative pain after knee arthroplasty based on average pain intensity scores.
null
Post Operative Pain
Oxycodone Naloxone Postoperative pain Arthroplasty Efficacy
null
2
arm 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages) arm 2: Oxycodone PR 20mg or 10mg (twice a day) BID for 2.5 days (total 5 dosages)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg intervention 2: Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
intervention 1: Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets intervention 2: Oxycodone
1
Pori | N/A | Finland | 21.78333 | 61.48333
137
0
0
0
NCT01083485
1COMPLETED
2010-11-01
2010-03-01
Mundipharma Oy
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
118
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components comp...
null
Chronic Obstructive Pulmonary Disease
COPD
null
8
arm 1: PT003 MDI Dose 1 arm 2: PT003 MDI Dose 2 arm 3: PT005 MDI Dose 1 arm 4: PT005 MDI Dose 2 arm 5: Placebo MDI arm 6: Tiotropium Bromide inhalation powder arm 7: Formoterol fumarate inhalation powder 12 μg arm 8: PT001 MDI Dose 1
[ 0, 0, 0, 0, 2, 1, 1, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Inhaled PT003 MDI administered as two puffs BID for 7 days intervention 2: Inhaled PT005 MDI administered as two puffs BID for 7 days intervention 3: Inhaled placebo administered as two puffs BID for 7 days intervention 4: Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days...
intervention 1: PT003 MDI intervention 2: PT005 MDI intervention 3: Placebo MDI intervention 4: Tiotropium bromide 18 μg (Spiriva Handihaler®) intervention 5: Formoterol Fumarate 12 μg (Foradil® Aerolizer®) intervention 6: PT001 MDI
16
Clearwater | Florida | United States | -82.8001 | 27.96585 Charlotte | North Carolina | United States | -80.84313 | 35.22709 Medford | Oregon | United States | -122.87559 | 42.32652 Spartanburg | South Carolina | United States | -81.93205 | 34.94957 Caringbah | New South Wales | Australia | 151.12468 | -34.03534 Glebe ...
418
0
0
0
NCT01085045
1COMPLETED
2010-11-01
2010-03-01
Pearl 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
[ 2 ]
40
RANDOMIZED
SEQUENTIAL
0TREATMENT
2DOUBLE
false
2MALE
false
This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.
This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), wer...
Hypertension
Hypertension
null
5
arm 1: MK-8266 1 mg (0.7 mg in the morning \[AM\] + 0.3 mg in the evening \[PM\]), or as matching placebo BID. arm 2: MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID. arm 3: MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \[q6hr\]), or as matching placebo TID. arm 4: MK-8266 TID (Panel D), 2.4 ...
[ 0, 0, 0, 0, 0 ]
10
[ 0, 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B. intervention 2: MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C...
intervention 1: MK-8226 BID, 1 mg intervention 2: MK-8266 BID, 1.8 mg intervention 3: MK-8266 TID, 1.8 mg intervention 4: MK-8266 TID, 2.4 mg intervention 5: MK-8266 TID, 2.4 mg intervention 6: Placebo BID (Panel A) intervention 7: Placebo BID (Panel B) intervention 8: Placebo TID (Panel C) intervention 9: Placebo TID ...
0
null
40
0
0
0
NCT01096160
1COMPLETED
2010-11-01
2010-03-01
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
[ 0 ]
1
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
true
While neurocognitive impairments in attention, memory and executive functioning are commonly reported sequelae of childhood leukemia and brain tumors, studies have only recently begun to examine the treatment of attention deficits in this population. Numerous studies have examined the effectiveness of methylphenidate i...
null
ALL, Childhood Leukemia, Lymphoblastic Leukemia, Lymphoblastic, Acute Leukemia, Lymphoblastic, Acute, L1 Leukemia, Lymphoblastic, Acute, L2 Leukemia, Lymphoblastic, Acute, Philadelphia-Positive Leukemia, Lymphocytic, Acute Leukemia, Lymphocytic, Acute, L1 Leukemia, Lymphocytic, Acute, L2 Lymphoblastic Leukemia Lymphobl...
null
2
arm 1: Administered 1 capsule each day for 1 week, .3 mg/kg dose. arm 2: Administered 1 capsule each day for 1 week.
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 1 capsule each day for 1 week, .3 mg/kg dose. intervention 2: 1 capsule per day for 1 week.
intervention 1: Methylphenidate intervention 2: Placebo
1
Minneapolis | Minnesota | United States | -93.26384 | 44.97997
0
0
0
0
NCT01100658
6TERMINATED
2010-11-01
2010-05-01
University of Minnesota
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
31
RANDOMIZED
SEQUENTIAL
0TREATMENT
2DOUBLE
true
1FEMALE
null
The main purpose of this study is to assess the safety, tolerability and potential immune response to romosozumab following single subcutaneous (SC; injection under the skin) dose administration in healthy postmenopausal Japanese and non-Japanese women.
null
Osteopenia
Amgen Phase 1 Postmenopausal Japanese
null
2
arm 1: Japanese women in cohorts 1, 2, and 4 will receive a single dose of 1, 3, or 5 mg/kg romosozumab. Non-Japanese women in cohort 3 will receive a single dose of 3 mg/kg romosozumab. arm 2: Participants will receive a single dose of placebo.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Administered by subcutaneous injection intervention 2: Administered by subcutaneous injection
intervention 1: Romosozumab intervention 2: Placebo
0
null
30
0
0
0
NCT01101061
1COMPLETED
2010-11-01
2010-05-03
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
[ 2 ]
36
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
null
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
null
Hepatic Insufficiency Healthy
null
1
arm 1: 50 mg single dose
[ 0 ]
1
[ 0 ]
intervention 1: 2 tablets BI 10773 25 mg single dose
intervention 1: BI 10773
1
Timișoara | N/A | Romania | 21.22571 | 45.75372
36
0
0
0
NCT01111318
1COMPLETED
2010-11-01
2010-07-01
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 ]
38
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
This study will test the relationship between CBP (central blood pressure) and PBP (peripheral blood pressure) effects after single and multiple doses of Isosorbide mononitrate extended release (ISMN ER) or Amlodipine besylate in participants with hypertension.
null
Hypertension
null
6
arm 1: Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. arm 2: Participants rece...
[ 0, 0, 0, 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo, capsule taken orally once daily during 4 weeks of treatment intervention 2: Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks intervention 3: ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
intervention 1: Placebo intervention 2: Comparator: Amlodipine intervention 3: Comparator: ISMN ER
0
null
109
0
0
0
NCT01130168
1COMPLETED
2010-11-01
2010-05-01
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 ]
131
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
This is a 6-week study treatment to evaluate the safety and effectiveness of AZD2066 in patients with major depressive disorder.
A Phase IIa, Multi-centre, Randomized, Double-Blind, Double-Dummy, Active and Placebo Controlled, parallel Group Study to Assess the Efficacy and Safety of AZD2066 after 6 weeks of treatment in Patients with Major Depressive Disorder - D0475C00020.
Major Depressive Disorder
Depression
null
3
arm 1: None arm 2: None arm 3: Duloxetine
[ 0, 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 18 mg once daily intervention 2: None intervention 3: 60 mg once daily
intervention 1: AZD2066 intervention 2: Placebo intervention 3: Duloxetine
13
Garden Grove | California | United States | -117.94145 | 33.77391 San Diego | California | United States | -117.16472 | 32.71571 Jacksonville | Florida | United States | -81.65565 | 30.33218 Atlanta | Georgia | United States | -84.38798 | 33.749 Rockville | Maryland | United States | -77.15276 | 39.084 Boston | Massach...
131
0
0
0
NCT01145755
6TERMINATED
2010-11-01
2010-05-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
7
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
null
Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of \[14C\]volasertib in patients with advanced solid tumours.
null
Neoplasms
null
1
arm 1: BI 6727 cycles in every 21 days
[ 0 ]
1
[ 0 ]
intervention 1: PLK-1 inhibitor
intervention 1: BI 6727
1
Budapest | N/A | Hungary | 19.04045 | 47.49835
26
0
0
0
NCT01145885
1COMPLETED
2010-11-01
2010-06-01
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 ]
133
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This is a prospective, randomized, controlled and multi-center trial to assess the use of colposeptine in female subjects with bacterial vaginosis. A total of 480 subjects were planned to be enrolled in various centers in China.
null
Vaginosis, Bacterial
Vaginosis, Bacterial Colposeptine Metronidazole
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days intervention 2: Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
intervention 1: Colposeptine intervention 2: Metronidazole
5
Beijing | N/A | China | 116.39723 | 39.9075 Chengdu | N/A | China | 104.06667 | 30.66667 Shanghai | N/A | China | 121.45806 | 31.22222 Shenzhen | N/A | China | 114.0683 | 22.54554 Wuhan | N/A | China | 114.26667 | 30.58333
133
0
0
0
NCT01153958
6TERMINATED
2010-11-01
2010-07-01
Merck KGaA, Darmstadt, Germany
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
36
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on the pharmacokinetics (PK) of crizotinib when a...
The purpose of this study is to demonstrate bioequivalence of the CIC relative to IRT and CIC relative to PIC, and lack of an effect of food on the PK of crizotinib in healthy volunteers.
Healthy
bioequivalence food effect pharmacokinetics crizotinib
null
1
arm 1: All subjects will receive four treatments in one of the indicated orders: A-B-C-D, B-D-A-C, C-A-D-B, D-C-B-A
[ 0 ]
1
[ 0 ]
intervention 1: Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs. Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs. Treatment C (Test for BE, Reference for ...
intervention 1: crizotinib
1
Brussels | N/A | Belgium | 4.34878 | 50.85045
144
0
0
0
NCT01154218
1COMPLETED
2010-11-01
2010-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
80
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from additional control of blood glucose levels. The study assessed the metabolic effects of ranolazine, including its effect ...
null
Diabetes Mellitus, Type 2
Type 2 diabetes mellitus T2DM Ranolazine Ranexa HbA1c
null
2
arm 1: Participants were randomized to receive ranolazine for 12 weeks. arm 2: Participants were randomized to receive placebo to match ranolazine for 12 weeks.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily intervention 2: Placebo to match ranolazine administered orally twice daily
intervention 1: Ranolazine intervention 2: Placebo
9
Escondido | California | United States | -117.08642 | 33.11921 Los Angeles | California | United States | -118.24368 | 34.05223 Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Overland Park | Ka...
80
0
0
0
NCT01163721
1COMPLETED
2010-11-01
2010-06-01
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
[ 0 ]
46
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
false
The overall goals of this study are to (1) expand knowledge about interactions of levetiracetam with alcohol by assessing the effects of levetiracetam compared to placebo in moderate and heavy social alcohol users and (2) to test the AccuswayTM platform as a tool to measure postural control (which has been used as a ma...
The investigators propose a 42-day, double-blind, placebo-controlled crossover study in light to moderate and heavy alcohol users who are social drinkers. The specific aims are to: 1. Determine if levetiracetam alters daily alcohol consumption by comparing the mean drinks consumed per day during levetiracetam adminis...
Alcohol Abuse Drug Abuse
keppra levetiracetam alcoholism genetics subjective report
null
2
arm 1: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days. arm 2: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 m...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days. Group B: Twenty moderate to heavy social alcohol users will receive 500 mg leve...
intervention 1: Levetiracetam (Keppra) intervention 2: Placebo
1
Berkeley | California | United States | -122.27275 | 37.87159
92
0
0
0
NCT01168687
1COMPLETED
2010-11-01
2008-11-01
University of California, San Francisco
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 ]
15
NA
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
true
Sarcoidosis is a granulomatous disease for which the molecular and immunologic association with mycobacteria continues to strengthen. The investigators are interested in conducting a proof-of-concept investigation of the effects of antibiotics on sarcoidosis resolution. The investigators hypothesize that pulmonary sarc...
null
Pulmonary Sarcoidosis Lung Function
sarcoidosis mycobacteria lung pulmonary radiographic improvement
null
1
arm 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \*\*Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \*\*We will not use both, but either one or the other ba...
[ 1 ]
1
[ 0 ]
intervention 1: Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD \*\*Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. \*\*We will not use both, but either one or the...
intervention 1: levaquin; ethambutol; rifampin and azithromycin.
1
Nashville | Tennessee | United States | -86.78444 | 36.16589
15
0
0
0
NCT01169038
1COMPLETED
2010-11-01
2010-07-01
Vanderbilt 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 ]
148
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010), in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks of treatment. The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide, in reducing postprandial ...
The duration of the study for each patient is up to 7 weeks including a screening period up to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/- 2 days after last study drug administration.
Type 2 Diabetes Mellitus
null
2
arm 1: 1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) for 2 weeks, followed by 20 mcg QD for up to Week 4. arm 2: 2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
[ 0, 1 ]
5
[ 0, 1, 0, 1, 0 ]
intervention 1: Self administered by subcutaneous injections once daily 30 minutes before breakfast. intervention 2: None intervention 3: Self administered by subcutaneous injections once daily 30 minutes before breakfast. intervention 4: None intervention 5: Metformin to be continued at stable dose (1.5 gram per day) ...
intervention 1: Lixisenatide (AVE0010) intervention 2: Pen auto-injector intervention 3: Liraglutide intervention 4: Pre-filled pen injector intervention 5: Metformin
7
Berlin | N/A | Germany | 13.41053 | 52.52437 Kiel | N/A | Germany | 10.13489 | 54.32133 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 Mönchengladbach | N/A | Germany | 6.44172 | 51.18539 München | N/A | Germany | 13.31243 | 51.60698 Neuss | N/A | Germany | 6.68504 | 51.19807
148
0
0
0
NCT01175473
1COMPLETED
2010-11-01
2010-08-01
Sanofi
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 ]
28
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
To determine the pharmacokinetic profile of 80 mg telmisartan / 5 mg amlodipine (T80/A5) dose combination after single dose in healthy Chinese subjects. To determine whether a pharmacokinetic interaction exists between telmisartan and amlodipine, following single doses of 80mg telmisartan (T80), and 5 mg amlodipine (A...
null
Healthy
null
1
arm 1: all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
[ 0 ]
1
[ 0 ]
intervention 1: patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.
intervention 1: amlodipine/telmisartan/combination
1
Shanghai | N/A | China | 121.45806 | 31.22222
80
0
0
0
NCT01181011
1COMPLETED
2010-11-01
2010-08-01
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 ]
42
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
The primary objective of the current study is to investigate the relative bioavailability of BI 10773 / linagliptin fixed dose combination tablet (formulation A1, Treatment A, Test) compared to BI 10773 given in free combination with linagliptin (Treatment B, Reference), both in the fasting state. All 42 subjects enter...
null
Healthy
null
4
arm 1: medium single dose ofBI 10773/linagliptin FDC (Formulation A1) arm 2: medium single dose of mono components BI 10773/linagliptin arm 3: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal arm 4: medium single dose of BI 10773/linagliptin FDC (Formulation A3)
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: medium single dose of BI 10773/linagliptin FDC (Formulation A1) intervention 2: medium single dose of BI 10773/linagliptin FDC (Formulation A3) intervention 3: medium single dose of mono components BI 10773/linagliptin intervention 4: medium single dose of BI 10773/linagliptin FDC (Formulation A1) after...
intervention 1: BI 10773/linagliptin intervention 2: BI 10773/linagliptin intervention 3: BI 10773/linagliptin SID intervention 4: BI 10773/linagliptin FDC
1
Biberach | N/A | Germany | 8.03333 | 48.33333
125
0
0
0
NCT01189201
1COMPLETED
2010-11-01
2010-08-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
Phase IIB study to find the optimal dose rate range of propofol to maintain minimal-to-moderate sedation for diagnostic gastrointestinal endoscopy and gastrointestinal polypectomy.
null
Gastrointestinal Endoscopy Gastrointestinal Polypectomy
propofol endoscopy sedation
null
7
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None
[ 2, 1, 1, 1, 1, 1, 1 ]
7
[ 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Infusion of placebo, same infusion rates as for arm 2 intervention 2: Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute intervention 3: Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute in...
intervention 1: Placebo intervention 2: ICI35,868 (propofol) intervention 3: ICI35,868 (propofol) intervention 4: ICI35,868 (propofol) intervention 5: ICI35,868 (propofol) intervention 6: ICI35,868 (propofol) intervention 7: ICI35,868 (propofol)
2
Isesaki | Gunma | Japan | 139.2 | 36.31667 Moriya | Ibaragi | Japan | 140.0 | 35.93333
120
0
0
0
NCT01189604
1COMPLETED
2010-11-01
2010-08-01
AstraZeneca
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
41
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
To determine the bioequivalence of 2 tablets of 25 mg sustained release (SR) formulation of DVS and 1 tablet of 50 mg SR formulation of DVS under fed and fast conditions. To investigate the effect of high-fat meal on pharmacokinetics of desvenlafaxine after administration of 50 mg SR formulation of DVS.
null
Depression - Major Depressive Disorder
DVS SR healthy Bioequivalence study
null
1
arm 1: None
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Two tablets of 25 mg, single administration, under fed condition intervention 2: One tablet of 50 mg, single administration, under fed condition intervention 3: Two tablets of 25 mg, single administration, under fast condition intervention 4: One tablet of 50 mg, single administration, under fast condit...
intervention 1: desvenlafaxine succinate sustained release intervention 2: desvenlafaxine succinate sustained release intervention 3: desvenlafaxine succinate sustained release intervention 4: desvenlafaxine succinate sustained release
1
Brussels | N/A | Belgium | 4.34878 | 50.85045
160
0
0
0
NCT01190514
1COMPLETED
2010-11-01
2010-09-01
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
[ 2 ]
30
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
true
0ALL
null
The objective of this study is to demonstrate that BI 10773 does not prolong the QT(c) interval more than placebo
null
Healthy
null
3
arm 1: single oral (high and low) dose per subject arm 2: 2 single oral doses per subject arm 3: single oral dose per subject
[ 0, 2, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: single oral dose intervention 2: single oral dose intervention 3: 2 times single dose intervention 4: single oral dose
intervention 1: BI 10773 (low) intervention 2: Moxifloxacin intervention 3: BI 10773 Placebo intervention 4: BI 10773 (high)
1
Biberach | N/A | Germany | 8.03333 | 48.33333
116
0
0
0
NCT01195675
1COMPLETED
2010-11-01
2010-08-01
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 ]
2
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU, Canada and Australia. In this study, the safety and efficacy after administrations of sitaxentan sodium at a dose of 100 mg alone or in combin...
null
Hypertension, Pulmonary
sitaxentan sodium hypertension
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: sitaxentan sodium 100 mg
intervention 1: Sitaxentan
2
Nagoya | Aichi-ken | Japan | 136.90641 | 35.18147 Shinjyuku-ku | Tokyo | Japan | N/A | N/A
2
0
0
0
NCT01204853
6TERMINATED
2010-11-01
2010-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
54
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The objectives of this study are to compare the relative bioavailabilities of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) in plasma from a single dose of Epanova or Lovaza during periods of high- and low -fat consumption.
null
Severe Hypertriglyceridemia
Eicosapentaenoic Acid Docosahexaenoic Acid Hypertriglyceridemia Omega-3 acid ethyl esters Omega-3 carboxylic acids Epanova Lovaza bioavailability pharmacokinetics low-fat meal high-fat meal
null
2
arm 1: None arm 2: None
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washo...
intervention 1: Epanova (4 g) and Lovaza (4 g) intervention 2: Lovaza (4 g) and Epanova (4 g)
1
Chicago | Illinois | United States | -87.65005 | 41.85003
54
0
0
0
NCT01208961
1COMPLETED
2010-11-01
2010-09-01
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 ]
32
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
Nocturia
null
2
arm 1: SER120 Level 1 (500 ng/day) arm 2: SER120 Level 2 (750 ng/day)
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: SER120 Level 1 intervention 2: SER120 (750 ng/day)
intervention 1: SER120 Nasal Spray 500 ng/day intervention 2: SER120 nasal spray 750 ng/day
1
San Antonio | Texas | United States | -98.49363 | 29.42412
32
0
0
0
NCT01259128
1COMPLETED
2010-11-01
2010-04-01
Serenity Pharmaceuticals, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NA
SINGLE_GROUP
4SUPPORTIVE_CARE
0NONE
true
0ALL
false
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline
The purpose of this study was to determine the safety and pharmacokinetics of the standard dose of intranasal Kovacaine Mist of 0.6 mL (18 mg tetracaine HCl with 0.3 mg oxymetazoline HCl) and a proposed maximum recommended dental dose of 1.2 mL (36 mg tetracaine HCl with 0.6 mg oxymetazoline HCl). The primary objective...
Anesthesia
null
1
arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 6 sprays of 0.1 mL - total of 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl followed by 12 sprays of 0.1 mL - total of 36 mg tetracaine HCl and 0.6 mg oxymetazoline HCl
[ 0 ]
1
[ 0 ]
intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
1
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238
24
0
0
0
NCT01304316
1COMPLETED
2010-11-01
2010-09-01
St. Renatus, LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
A double blinded randomized controlled trial comparing the onset and duration of the Onset and Duration of Ultrasound Guided Supraclavicular Nerve Blocks Using a long acting local anesthestic (Ropivacaine) with a mixture of a long and short acting local anesthestic (Ropivacaine-Chloroprocaine Mixture).
Patients will be met preoperatively in the pre-anesthesia holding area as is typical for most orthopedic procedures. An attending anesthesiologist will evaluate the patient and planned surgical procedure and determine if the best anesthetic plan includes a supraclavicular brachial plexus block and will ensure that the ...
Pain
Onset Duration Upper Limb Block Ultrasound guided supraclavicular block Ropivacaine Chloroprocaine
null
2
arm 1: 20 ml's of 1% ropivacaine + 10 ml's of 3% 2-chloroprocaine + 0.1 ml of 1 mg/ml epinephrine arm 2: 30 ml syringe with either 20 ml's of 1% ropivacaine + 10 ml's of normal saline + 0.1 ml of 1mg/ml epinephrine
[ 1, 3 ]
2
[ 0, 0 ]
intervention 1: Chloroprocaine is added to Ropivacaine intervention 2: Ropivacaine diluted with normal saline instead of chloroprocaine
intervention 1: Ropivacine and Chloroprocaine mixture intervention 2: Ropivacaine only
1
Albuquerque | New Mexico | United States | -106.65114 | 35.08449
59
0
0
0
NCT01719237
1COMPLETED
2010-11-01
2009-08-01
University of New Mexico
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 ]
54
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Acute atrial fibrillation is the most common sustained, clinically significant dysrhythmia encountered in the emergency department (ED) and the most common dysrhythmia treated by emergency physicians. Atrial flutter is less common than atrial fibrillation but its management in the ED is very similar, and the majority o...
We conducted a prospective, randomized, double-blind study to compare the effectiveness of intravenous metoprolol with that of diltiazem in achieving rate control in adult ED patients with rapid atrial fibrillation or flutter. Approval of the study was obtained from our hospital's institutional review board. All enroll...
Heart Rate and Rhythm Disorders
metoprolol diltiazem heart rate
null
2
arm 1: Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg) arm 2: Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Metoprolol intervention 2: Diltiazem
1
Brooklyn | New York | United States | -73.94958 | 40.6501
54
0
0
0
NCT01914926
1COMPLETED
2010-11-01
2009-06-01
Antonios Likourezos
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 ]
194
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
false
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder (ADHD).
This is an open-label (all people know the identity of the intervention), prospective (study following participants forward in time), self-controlled, long-term post-marketing study in participants with ADHD. The study consists of 3 periods: screening period, wash-out period/run-in period (3 days), and open-label treat...
Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder Methylphenidate Hydrochloride CONCERTA
null
2
arm 1: Participants with ADHD will receive OROS -MPH starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance. arm 2: Participants did ...
[ 0, 1 ]
2
[ 0, 10 ]
intervention 1: Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolera...
intervention 1: Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH) intervention 2: No intervention
6
Beijing | N/A | China | 116.39723 | 39.9075 Changchun | N/A | China | 125.32278 | 43.88 Guangzhou | N/A | China | 113.25 | 23.11667 Hangzhou | N/A | China | 120.16142 | 30.29365 Shanghai | N/A | China | 121.45806 | 31.22222 Shenzhen | N/A | China | 114.0683 | 22.54554
149
0
0
0
NCT01933880
1COMPLETED
2010-11-01
2009-12-01
Xian-Janssen Pharmaceutical Ltd.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
302
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis who have had an inadequate response to one prior anti-TNF alpha inhibitor. MabThera-naive patients will be stratified into 3 arms, according to previous inadequate response to a)etanercept, b)infliximab or c)adalim...
null
Rheumatoid Arthritis
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 1 g was given by intravenous infusion on Days 1 and 15
intervention 1: rituximab [MabThera]
69
Bad Abbach | N/A | Germany | 12.04494 | 48.93754 Bad Aibling | N/A | Germany | 12.01055 | 47.8638 Bad Bramstedt | N/A | Germany | 9.88243 | 53.91827 Bamberg | N/A | Germany | 10.90067 | 49.89873 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 |...
302
0
0
0
NCT02079532
1COMPLETED
2010-11-01
2006-11-01
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
0
0
0
0
0
0
0
0
0
[ 2 ]
40
RANDOMIZED
CROSSOVER
0TREATMENT
1SINGLE
true
0ALL
false
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects, to demonstrate the bioequivalence (BE) between two active product ingredient (API) sources of eslicarbazepine acetate (ESL)
Phase I, two-centre, open-label, randomized, gender-balanced, single-dose, laboratory blinded, two-period, two-sequence, crossover study in 2 groups of 20 healthy male and female subjects. The study consisted in 2 periods separated by a wash-out of at least 7 days between doses. To demonstrate the bioequivalence (BE) b...
Epilepsy
null
2
arm 1: Subjects randomly received on period 1 and 2, either a single 400 mg tablet of ESL (MF - marketed formulation), or a single 400 mg tablet of ESL (TBM - o-be-marketed); arm 2: Subjects randomly received on period 1 and 2, either a single 800 mg tablet of ESL (MF - marketed formulation), or a single 800 mg dose of...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: MF - Marketed formulation intervention 2: TBM - to-be-marketed
intervention 1: BIA 2-093 intervention 2: BIA 2-093
0
null
158
0
0
0
NCT02284880
1COMPLETED
2010-11-01
2010-10-01
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 ]
41
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This study will evaluate the efficacy, safety and tolerability of long-term use of peginterferon alfa-2a in participants with CML who have previously participated in peginterferon alfa-2a study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and treating phys...
null
Myelogenous Leukemia, Chronic
null
1
arm 1: Participants will receive peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator.
[ 0 ]
1
[ 0 ]
intervention 1: Peginterferon alfa-2a in doses between 90 and 450 mcg will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator.
intervention 1: Peginterferon alfa-2a
5
Freiburg im Breisgau | N/A | Germany | 7.85222 | 47.9959 Mainz | N/A | Germany | 8.2791 | 49.98419 Mannheim | N/A | Germany | 8.46694 | 49.4891 Marburg | N/A | Germany | 8.77069 | 50.80904 Tübingen | N/A | Germany | 9.05222 | 48.52266
41
0
0
0
NCT02736721
1COMPLETED
2010-11-01
2003-09-01
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
42
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
null
false
The study assessed the safety and ability of an orally inhaled medicine \[i.e., Glycopyrrolate Inhalation Solution = GIS\] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS...
null
Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease COPD Emphysema Chronic bronchitis
null
6
arm 1: Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily arm 2: Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily arm 3: Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily arm 4: Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once dai...
[ 0, 0, 0, 0, 0, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily intervention 2: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily intervention 3: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily intervention 4: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily inter...
intervention 1: Glycopyrrolate Inhalation Solution12.5μg intervention 2: Glycopyrrolate Inhalation Solution 50μg intervention 3: Glycopyrrolate Inhalation Solution 100μg intervention 4: Glycopyrrolate Inhalation Solution 200μg intervention 5: Glycopyrrolate Inhalation Solution 400μg intervention 6: Placebo 0.5mL
0
null
225
0
0
0
NCT02948582
1COMPLETED
2010-11-01
2010-07-01
Sunovion Respiratory Development 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 ]
49
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
A major factor in the respiratory health of cystic fibrosis (CF) patients is acquisition of chronic Pseudomonas (P.) aeruginosa infections. The infection rate with P. aeruginosa increases with age and by age 18 years, 80% of patients with CF in the U.S. are infected. Liposomal amikacin for inhalation (LAI; Arikayce™) i...
Cystic fibrosis (CF) is a genetic disease resulting from mutations in a 230 kb gene on chromosome 7 known as the cystic fibrosis transmembrane conductance regulator (CFTR). Patients with CF manifest pathological changes in a variety of organs that express CFTR. The lungs are frequently affected, the sequelae being chro...
Cystic Fibrosis
Cystic Fibrosis Respiratory Infections Pulmonary Cystic Fibrosis CFTR
null
1
arm 1: Subjects in this cohort will receive 560 mg of Arikayce™
[ 0 ]
1
[ 0 ]
intervention 1: Amikacin (aminoglycoside) in a liposomal formulation.
intervention 1: Arikayce™
11
Leuven | N/A | Belgium | 4.70093 | 50.87959 Budapest | N/A | Hungary | 19.04045 | 47.49835 Kaposvár | N/A | Hungary | 17.8 | 46.36667 Skopje | N/A | North Macedonia | 21.43141 | 41.99646 Rabka-Zdrój | N/A | Poland | 19.96654 | 49.60889 Warsaw | N/A | Poland | 21.01178 | 52.22977 Belgrade | N/A | Serbia | 20.46513 | 44....
49
0
0
0
NCT03905642
1COMPLETED
2010-11-02
2009-01-08
Insmed Incorporated
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
306
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Heroin addiction is a growing problem in Russia; individuals who enter heroin addiction treatment often relapse. Therefore, effective heroin addiction treatments are necessary to prevent relapse. The purpose of this study is to compare oral naltrexone with a naltrexone implant that provides opioid blockade for two mont...
The usual treatment of heroin addiction in Russia involves detoxification and 2-4 weeks of rehabilitation with referral to outpatient follow-up. Though most patients complete inpatient treatment, few keep follow-up appointments and relapse rates are high. More effective therapies are needed, especially in view of the e...
Heroin Dependence Opioid-Related Disorders
null
3
arm 1: Oral naltrexone placebo (ONP) + Depot Naltrexone Implant (DNI) 1000 mg arm 2: Oral naltrexone (ON) 50 mg + Depot Naltrexone placebo Implant (DNIP) arm 3: Oral placebo naltrexone + placebo naltrexone implant
[ 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: naltrexone implant is 1000 mg naltrexone intervention 2: oral naltrexone 50 mg/day intervention 3: oral placebo naltrexone resembles active medication intervention 4: placebo implant resembles active medication
intervention 1: naltrexone implant intervention 2: oral naltrexone intervention 3: oral placebo naltrexone intervention 4: placebo implant
2
Philadelphia | Pennsylvania | United States | -75.16362 | 39.95238 Saint Petersburg | N/A | Russia | 30.31413 | 59.93863
306
0
0
0
NCT00218426
1COMPLETED
2010-11-04
2006-07-01
University of Pennsylvania
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 ]
24
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary purpose of this study is to determine the safety and tolerability of SRT501 (5.0 g) with or without concurrent bortezomib administration, when administered once daily in 21 day cycles, in male and female subjects with Multiple Myeloma. The purpose is also to define objective response (ORR, CR, PR, MR, SD) ...
This is an, open-label, phase II study of SRT501, alone or in combination with bortezomib, in subjects with measurable Multiple Myeloma. Sixty-one (61) evaluable subjects, who fulfill the inclusion/exclusion criteria, will be enrolled in this study. Pharmacokinetic (PK) samples will be collected from a subset of 15 sub...
Multiple Myeloma
null
1
arm 1: 5.0 g SRT501 will be administered for 20 consecutive days in a 21 day cycle for a maximum of 12 cycles. SRT501 will be administered at the same time each morning (approximately 15-30 minutes after breakfast) on all dosing days. No SRT501 administration will occur on Day 21 of each cycle. After the first two cyc...
[ 0 ]
2
[ 0, 0 ]
intervention 1: 5.0g SRT501 will be supplied in clinical kits as a powder which will be reconstituted with vehicle and water into a liquid suspension. SRT501 will be administered orally as a liquid suspension for 20 consecutive days in each 21 day cycle. intervention 2: Bortezomib (1.3 mg/m2) will be given as an intrav...
intervention 1: 5.0g SRT501 intervention 2: Bortezomib
5
Vejle | N/A | Denmark | 9.5357 | 55.70927 Sutton | Surrey | United Kingdom | -0.2 | 51.35 Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 Leeds | N/A | United Kingdom | -1.54785 | 53.79648 London | N/A | United Kingdom | -0.12574 | 51.50853
24
0
0
0
NCT00920556
6TERMINATED
2010-11-04
2009-03-30
Sirtris, a GSK Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
1,147
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This study will examine whether the incidence of hypoglycemia in patients fasting for Ramadan is lower when treated with sitagliptin as compared to sulfonylurea treatment.
This study and NCT01340768 (MK-0431-262) have the same design but are conducted under separate protocols, in different countries, according to local guidelines.
Type 2 Diabetes Mellitus (T2DM)
null
2
arm 1: Sitagliptin 100 mg administered orally daily as monotherapy or in combination with metformin over the Ramadan period. arm 2: Sulfonylurea administered orally daily as monotherapy or in combination with metformin over the Ramadan period.
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period. intervention 2: Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription intervention 3: Participants could continue pre-study metformin as ...
intervention 1: Sitagliptin phosphate intervention 2: Comparator: Sulfonylurea intervention 3: Metformin
0
null
1,021
0
0
0
NCT01131182
1COMPLETED
2010-11-04
2010-06-13
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 ]
35
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
2MALE
false
This Phase II single dose study was designed to characterize the safety, tolerability, and efficacy of intravenous (i.v.) panobinostat as a single-agent treatment in participants with hormone refractory prostate cancer.
null
Prostate Cancer
Prostate Cancer Adenocarcinoma Prostate-Specific Antigen metastatic male HRPC DACi
null
1
arm 1: Participants with metastatic hormone refractory prostate cancer received 20 milligrams per meter square (mg/m\^2) of panobinostat intravenously (i.v.) on Days 1 and 8 of a 21-day cycle. Treatment continued until disease progression as per investigator, intolerable toxicity, start of new cancer therapy, death, or...
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: Panobinostat
5
Baltimore | Maryland | United States | -76.61219 | 39.29038 Baltimore | Maryland | United States | -76.61219 | 39.29038 St Louis | Missouri | United States | -90.19789 | 38.62727 New York | New York | United States | -74.00597 | 40.71427 Madison | Wisconsin | United States | -89.40123 | 43.07305
35
0
0
0
NCT00667862
1COMPLETED
2010-11-05
2008-03-18
Novartis Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
47
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
To determine the pharmacokinetics of methadone in children and adults with SCD who are experiencing a painful episode.
null
Sickle Cell Disease
null
4
arm 1: Methadone comparison to standard of care for pain management arm 2: Morphine standard of Care pain management arm 3: Methadone comparison to standard of care for pain management arm 4: Morphine standard of Care pain management
[ 1, 1, 1, 1 ]
2
[ 0, 0 ]
intervention 1: Standard of care for pain management of acute episode of pain intervention 2: Compare to standard of care for pain management of acute episode of pain
intervention 1: Morphine intervention 2: Methadone
1
St Louis | Missouri | United States | -90.19789 | 38.62727
47
0
0
0
NCT00761085
1COMPLETED
2010-11-07
2008-01-01
Washington University School of Medicine
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 ]
629
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Africa, Europe and the United States of America (USA). The aim of the trial is to compare NN1250 (insulin degludec, soluble insulin basal analogue (SIBA)) plus insulin aspart with insulin glargine (IGlar) plus insulin aspart in patients with type 1 diabetes. The main period is registered in...
null
Diabetes Diabetes Mellitus, Type 1
null
2
arm 1: None arm 2: None
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Injected subcutaneously once daily. Dose was individually adjusted. intervention 2: Injected subcutaneously once daily. Dose individually adjusted. intervention 3: Injected subcutaneously as mealtime insulin. Dose was individually adjusted.
intervention 1: insulin degludec intervention 2: insulin glargine intervention 3: insulin aspart
91
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Peoria | Arizona | United States | -112.23738 | 33.5806 Concord | California | United States | -122.03107 | 37.97798 Fresno | California | United States | -119.77237 | 36.74773 Greenbrae | California |...
626
3
0.004792
1
NCT00982228
1COMPLETED
2010-11-08
2009-09-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
1
0
0
0
0
0
0
0
0
0
2
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.001631
[ 4 ]
1,106
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
Determination the efficacy of daily oral treatment with laquinimod 0.6 mg capsules as compared to placebo in subjects with Relapsing Remitting Multiple Sclerosis (RRMS).
null
Multiple Sclerosis
Relapsing Remitting
null
2
arm 1: Laquinimod 0.6 mg, oral arm 2: Matching placebo
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: Laquinimod 0.6 mg capsule, oral, once daily intervention 2: oral, once daily, capsule
intervention 1: Laquinimod intervention 2: Placebo
144
Phoenix | Arizona | United States | -112.07404 | 33.44838 Centennial | Colorado | United States | -104.87692 | 39.57916 Fort Collins | Colorado | United States | -105.08442 | 40.58526 New Haven | Connecticut | United States | -72.92816 | 41.30815 Northbrook | Illinois | United States | -87.82895 | 42.12753 Fort Wayne |...
1,106
0
0
0
NCT00509145
1COMPLETED
2010-11-08
2007-11-13
Teva Branded Pharmaceutical Products R&D, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
-0
[ 4 ]
742
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply ...
Acne Vulgaris
Acne
null
2
arm 1: Tazarotene foam, 0.1% arm 2: Vehicle Foam
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Tazarotene foam once a day application to the face intervention 2: Vehicle Foam once a day application to the face
intervention 1: Tazarotene Foam intervention 2: Vehicle Foam
18
Santa Monica | California | United States | -118.49138 | 34.01949 Miami | Florida | United States | -80.19366 | 25.77427 Alpharetta | Georgia | United States | -84.29409 | 34.07538 Snellville | Georgia | United States | -84.01991 | 33.85733 Evansville | Indiana | United States | -87.55585 | 37.97476 Louisville | Kentuc...
742
0
0
0
NCT01017120
1COMPLETED
2010-11-09
2009-10-01
Stiefel, a GSK Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
313
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
This study will examine the safety and efficacy of the addition of sitagliptin (MK-0431) compared to placebo in patients with type 2 diabetes mellitus with inadequate glycemic control who are taking pioglitazone and metformin.
null
Type 2 Diabetes Mellitus
null
2
arm 1: Sitagliptin 100 mg tablet orally once daily for 26 weeks. arm 2: Placebo to sitagliptin orally once daily for 26 weeks.
[ 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Sitagliptin 100 mg tablet orally once daily for 26 weeks. intervention 2: Placebo to sitagliptin 100 mg tablet orally once daily for 26 weeks. intervention 3: Participants taking 30 mg or more pioglitazone oral tablet(s) daily at screening in combination with metformin will enter a 4-week dose-stable pe...
intervention 1: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Pioglitazone intervention 4: Metformin intervention 5: Glipizide
0
null
313
0
0
0
NCT00885352
1COMPLETED
2010-11-10
2009-04-15
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The primary objective of this clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax (P. vivax) malaria
This is a multi-centre, randomised, double-blind, double-dummy, parallel group, comparative trial. It is a Phase III study designed to meet the regulatory requirements for registration of pyronaridine artesunate (PA) in Korea. Chloroquine will be used as a comparator, which is recognized as an effective and well-tolera...
Malaria
Artemisinin-based combination therapy (ACT) Pyramax Pyronaridine artesunate Chloroquine Children Adults Plasmodium vivax Republic of Korea
null
2
arm 1: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments h...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. intervention 2: Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
intervention 1: Pyronaridine - artesunate intervention 2: Chloroquine
2
Goyang-si | N/A | South Korea | 126.835 | 37.65639 Seoul | N/A | South Korea | 126.9784 | 37.566
30
0
0
0
NCT04368910
6TERMINATED
2010-11-15
2007-09-06
Medicines for Malaria Venture
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
682
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.
null
Alzheimer's Disease
Alzheimer's disease cognition SB-742457
null
3
arm 1: SB-742457 - 15mg added to existing donepezil treatment arm 2: Placebo added to existing donepezil arm 3: SB-742457 - 35mg added to existing donepezil
[ 0, 2, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: SB-742457 - 15mg added to existing donepezil treatment intervention 2: SB-742457 - 35mg added to existing donepezil intervention 3: Placebo added to existing donepezil intervention 4: existing donepezil treatment
intervention 1: SB-742457 15mg intervention 2: SB-742457 35mg intervention 3: Placebo intervention 4: donepezil 5-10mg
102
Litchfield Park | Arizona | United States | -112.35794 | 33.49337 Fresno | California | United States | -119.77237 | 36.74773 Rancho Mirage | California | United States | -116.41279 | 33.73974 San Francisco | California | United States | -122.41942 | 37.77493 Hallandale | Florida | United States | -80.14838 | 25.9812 H...
682
0
0
0
NCT00710684
1COMPLETED
2010-11-16
2008-07-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
50
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
1FEMALE
false
The purpose of this study is to see if consistent treatment with Botox will lead to longer lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this study a different dosing schedule of Botox inje...
null
Glabellar Furrows
Glabellar lines of moderate severity at maximum frown
null
1
arm 1: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
[ 0 ]
1
[ 0 ]
intervention 1: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
intervention 1: Botox
0
null
50
0
0
0
NCT00856999
1COMPLETED
2010-11-17
2005-02-08
Oregon Health and Science 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 ]
15
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
1FEMALE
true
RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor grow...
PRIMARY OBJECTIVES: I. To assess the feasibility of administering two sequential chemotherapy doublets with Avastin in the adjuvant setting. II. To assess the safety of Avastin in the adjuvant setting particularly regarding cardiac function, wound healing and toxicity of radiation. SECONDARY OBJECTIVES: I. To deter...
HER2-negative Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
null
1
arm 1: Doxorubicin 60 mg /M2 followed by cyclophosphamide 600 mg/M2 (AC) will be given every 2 weeks for cycles 1-4. Paclitaxel 175 mg/M2 followed by gemcitabine 1500 mg/M2 (TG) will be given every 2 weeks for cycles 5-8. Beginning cycle 5, B1= Avastin 10 mg/kg will be given as a single IV dose following each TG trea...
[ 0 ]
7
[ 0, 0, 2, 0, 0, 10, 2 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Correlative studies intervention 7: Given subcutaneously
intervention 1: doxorubicin hydrochloride intervention 2: cyclophosphamide intervention 3: bevacizumab intervention 4: paclitaxel intervention 5: gemcitabine hydrochloride intervention 6: laboratory biomarker analysis intervention 7: pegfilgrastim
1
Omaha | Nebraska | United States | -95.94043 | 41.25626
15
0
0
0
NCT00679029
6TERMINATED
2010-11-18
2008-05-02
University of Nebraska
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 ]
30
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
true
The purpose of this study is to evaluate the percentage of participants in each sotatercept dose regimen who achieve a hematopoietic response during the treatment period including up to 2 months after the last dose of sotatercept treatment of chemotherapy-induced anemia (CIA) in participants with metastatic breast canc...
null
Chemotherapy Induced Anemia
anemia metastatic breast cancer
Prot_000.pdf: Official Protocol Title: NCT number: NCT00931606 Document Date: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study of ACE-011 for the Treatment of Chemotherapy Induced Anemia in Patients with Metastatic Breast Cancer 13-Mar-2009 CLINICAL STUDY PROTOCOL A Phase 2, Double-Blind, Randomized...
4
arm 1: Participants will receive sotatercept 0.1 mg/kg subcutaneously every 28 days up to 4 doses. arm 2: Participants will receive sotatercept 0.3 mg/kg subcutaneously every 28 days up to 4 doses. arm 3: Participants will receive sotatercept 0.5 mg/kg subcutaneously every 28 days up to 4 doses. arm 4: Participants wil...
[ 0, 0, 0, 2 ]
2
[ 2, 0 ]
intervention 1: up to 4 subcutaneous doses of sotatercept given once every 28 days intervention 2: up to 4 subcutaneous doses of placebo given once every 28 days
intervention 1: Sotatercept intervention 2: Placebo
35
Sedona | Arizona | United States | -111.76099 | 34.86974 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Beverly Hills | California | United States | -118.40036 | 34.07362 Corona | California | United States | -117.56644 | 33.87529 Fountain Valley | California | United States | -117.95367 | 33.70918 Monteb...
60
0
0
0
NCT00931606
6TERMINATED
2010-11-18
2009-06-01
Merck Sharp & Dohme LLC
4INDUSTRY
true
true
false
https://cdn.clinicaltrials.gov/large-docs/06/NCT00931606/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/06/NCT00931606/SAP_001.pdf
0
0
0
0
0
0
0
0
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 ]
607
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to investigate the analgesic efficacy and safety of tanezumab added on to diclofenac SR in patients with osteoarthritis of the knee or hip currently experiencing partial benefit from, and are tolerating, diclofenac 150 mg/day therapy.
This study was terminated on 16 Nov 2010 following a US FDA clinical hold for tanezumab osteoarthritis clinical studies which halted dosing and enrollment of patients on 23 June 2010 for potential safety issues.
Osteoarthritis
Arthritis monoclonal antibody nerve growth factor (NGF) anti-NGF tanezumab PF-04383119 RN-624 OA
null
4
arm 1: IV tanezumab 10 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 2: IV tanezumab 5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through Week 32) arm 3: IV tanezumab 2.5 mg every 8 weeks (through Week 16) and oral diclofenac SR 75 mg BID (through We...
[ 0, 0, 0, 2 ]
8
[ 2, 0, 2, 0, 2, 0, 0, 10 ]
intervention 1: IV tanezumab 10 mg every 8 weeks (through Week 16) intervention 2: Oral diclofenac SR 75 mg BID for 32 weeks intervention 3: IV tanezumab 5 mg every 8 weeks (through Week 16) intervention 4: Oral diclofenac SR 75 mg BID for 32 weeks intervention 5: IV tanezumab 2.5 mg every 8 weeks (through Week 16) int...
intervention 1: tanezumab intervention 2: diclofenac intervention 3: tanezumab intervention 4: diclofenac intervention 5: tanezumab intervention 6: diclofenac intervention 7: diclofenac intervention 8: IV placebo
77
Graz | N/A | Austria | 15.45 | 47.06667 Senftenberg | N/A | Austria | 15.54452 | 48.45222 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Vienna | N/A | Austria | 16.37208 | 48.20849 Nantes | N/A | France | -1.55336 | 47.21725 Paris | N/A | France | 2.3488 | 48.85341 Berlin | N...
604
0
0
0
NCT00864097
6TERMINATED
2010-11-24
2009-08-11
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of this study was to assess the efficacy of 3 dose levels of lusutrombopag (0.5 mg, 0.75 mg, and 1.0 mg) and placebo on platelet count.
null
Immune Thrombocytopenia (ITP)
Blood Platelet Disorders Immune Thrombocytopenia (ITP) Low Platelet Count Thrombocytopaenia S-888711 Splenectomy Thrombopoiesis Hematologic Disease Auto-immune thrombocytopenic Purpura Relapsed Persistent or Chronic ITP Idiopathic Thrombocytopenic Purpura Thrombotic Thrombocytopenic Purpura (TTP)
null
4
arm 1: Participants received placebo tablets orally once a day for 42 days. arm 2: Participants received 0.5 mg lusutrombopag orally once a day for 42 days. arm 3: Participants received 0.75 mg lusutrombopag orally once a day for 42 days. arm 4: Participants received 1.0 mg lusutrombopag orally once a day for 42 days.
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Tablet intervention 2: Tablet
intervention 1: Placebo intervention 2: Lusutrombopag
19
Anaheim | California | United States | -117.9145 | 33.83529 Los Angeles | California | United States | -118.24368 | 34.05223 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Boynton Beach | Florida | United States | -80.06643 | 26.52535 Jacksonville | Florida | United States | -81.65565 | 3...
20
0
0
0
NCT01054443
6TERMINATED
2010-11-24
2010-03-18
Shionogi
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 ]
161
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inv...
null
ADHD Specifically With Executive Function Impairment
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 10 ]
intervention 1: 1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks) intervention 2: 1 capsule per day, daily throughout the double-blind treatment period (10 weeks)
intervention 1: SPD489 intervention 2: Placebo
39
Little Rock | Arkansas | United States | -92.28959 | 34.74648 Rolling Hills Estates | California | United States | -118.35813 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Bradenton | Florida | United States | -82.57482 | 27.49893 Fort Myers | Florida | United States | -81.84059 | 26.62168 J...
159
0
0
0
NCT01101022
1COMPLETED
2010-11-29
2010-05-19
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 ]
191
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in patients with chronic renal anemia not on dialysis.Patients will receive sc Mircera at a starting dose of 100, 120, 200 or 360 micrograms every 4 wee...
null
Anemia
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: sc every month (starting dose of 100, 120, 150 or 200 micrograms based on previous ESA therapy)
intervention 1: methoxy polyethylene glycol-epoetin beta [Mircera]
10
Busan | N/A | South Korea | 129.03004 | 35.10168 Daegu | N/A | South Korea | 128.59111 | 35.87028 Daejeon | N/A | South Korea | 127.38493 | 36.34913 Gwangju | N/A | South Korea | 126.91556 | 35.15472 Kyonggi-do | N/A | South Korea | N/A | N/A Seoul | N/A | South Korea | 126.9784 | 37.566 Seoul | N/A | South Korea | 126...
191
0
0
0
NCT00922116
1COMPLETED
2010-11-30
2009-04-30
Hoffmann-La Roche
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
931
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot. Key objectives of the study are to: * Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, * Evaluate the safet...
null
Schizophrenic Disorders Schizoaffective Disorder
null
1
arm 1: Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
[ 0 ]
1
[ 0 ]
intervention 1: 45-405 milligram (mg), intramuscular injection, on a 2-, 3-, or 4-week interval.
intervention 1: Intramuscular olanzapine depot
92
Orange | California | United States | -117.85311 | 33.78779 Pasadena | California | United States | -118.14452 | 34.14778 San Diego | California | United States | -117.16472 | 32.71571 Santa Ana | California | United States | -117.86783 | 33.74557 Washington D.C. | District of Columbia | United States | -77.03637 | 38....
931
3
0.003222
1
NCT00088465
1COMPLETED
2010-12-01
2004-08-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0.001096
[ 4 ]
445
NON_RANDOMIZED
SINGLE_GROUP
2DIAGNOSTIC
0NONE
false
0ALL
false
Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
The purpose of this clinical research study is to determine how well CARDIOLITE® rest and stress myocardial (heart) imaging can define the pediatric Kawasaki disease (KD) population into high and low risk categories of developing cardiac (heart) events (complications) from 1 year through 3 years after image completion....
Kawasaki Disease
null
2
arm 1: Children 4-11 years of age, intervention Sestamibi arm 2: Adolescents 12-16 years of age, intervention Sestamibi
[ 5, 5 ]
1
[ 0 ]
intervention 1: Sestamibi
intervention 1: Sestamibi
50
Anchorage | Alaska | United States | -149.90028 | 61.21806 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Los Angeles | California | United States | -118.24368 | 34.05223 Orange | California | United States | -117.85311 | 33.78779 San Diego | California | United States | -117.16472 | 32.71571 Denver | Co...
445
1
0.002247
1
NCT00162032
1COMPLETED
2010-12-01
2005-08-01
Lantheus Medical Imaging
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000397
[ 3 ]
121
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study will be to determine the progression free survival of patients with stage IIIb/IV non-small cell lung cancer (NSCLC) treated with dual agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with two different regimens of paclitaxel and carboplatin ch...
null
Non-Small Cell Lung Cancer
Non-Small Cell Lung Cancer Malignant pleural effusions
null
2
arm 1: Cycles 1-6: * Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week * Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle * Paclitaxel 200 mg/m² on day 1 of every 3 week cycle * Carboplatin area under curve (AUC=6 min\*mg/mL) on day 1 of every 3 week cycle Patients who demonstrate...
[ 1, 1 ]
4
[ 2, 2, 0, 0 ]
intervention 1: Administered intravenously intervention 2: Administered intravenously intervention 3: Administered intravenously intervention 4: Administered intravenously
intervention 1: Cetuximab intervention 2: Bevacizumab intervention 3: Paclitaxel intervention 4: Carboplatin
43
Decatur | Alabama | United States | -86.98334 | 34.60593 Huntsville | Alabama | United States | -86.58594 | 34.7304 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Fountain Valley | California | United States | -117.95367 | 33.70918 Grass Valley | California | United States | -121.06106 | 39.21906 Greenbra...
116
3
0.025862
1
NCT00343291
1COMPLETED
2010-12-01
2006-12-01
Eli Lilly and Company
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
3
0
0
0
0
0
0
0
0.008834
[ 5 ]
190
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to investigate the safety and efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
This is an open-label, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER). The total study duration will be approximately of 48 weeks per par...
Schizophrenia
Schizophrenia Paliperidone Antipsychotics Agents
null
1
arm 1: Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
[ 0 ]
1
[ 0 ]
intervention 1: Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day.
intervention 1: Paliperidone
8
Busan | N/A | South Korea | 129.03004 | 35.10168 Chunjoo | N/A | South Korea | N/A | N/A Daegu | N/A | South Korea | 128.59111 | 35.87028 Goyang-si | N/A | South Korea | 126.835 | 37.65639 Ilsan | N/A | South Korea | 129.43333 | 35.5 Kyounggi | N/A | South Korea | N/A | N/A Kyunggi-Do | N/A | South Korea | N/A | N/A Se...
190
1
0.005263
1
NCT00761579
1COMPLETED
2010-12-01
2008-04-01
Janssen Korea, Ltd., Korea
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
0.00093
[ 4 ]
906
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in patients with COPD.
null
Pulmonary Disease, Chronic Obstructive
null
4
arm 1: Low dose inhaled orally once daily from the Respimat inhaler arm 2: High dose inhaled orally once daily from the Respimat inhaler arm 3: 12mcg inhaled twice daily from the Aerolizer inhaler arm 4: Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler and/or Formoterol placebo inhaled twice da...
[ 0, 0, 1, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Comparison of low and high doses on efficacy and safety in COPD patients intervention 2: Comparison of low and high doses on efficacy and safety in COPD patients intervention 3: Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients intervention 4: Placebo for comparison wit...
intervention 1: Olodaterol (BI 1744) intervention 2: Olodaterol (BI 1744) intervention 3: Formoterol intervention 4: Placebo intervention 5: Placebo
93
Capital Federal | N/A | Argentina | N/A | N/A Capital Federal | N/A | Argentina | N/A | N/A Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Monte Grande | N/A | Argentina | -58.46592 | -34.8194 Juiz de Fora | N/A | Brazil | -43.35028 | -21.76417 Rio de Janeiro | N/A | Brazil | -43.18223 | -22.90642 Rio de Janeir...
904
1
0.001106
1
NCT00793624
1COMPLETED
2010-12-01
2009-02-01
Boehringer Ingelheim
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0.000195
[ 3 ]
151
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in ...
Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.
Acute Coronary Syndrome
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 2 ]
3
[ 0, 0, 10 ]
intervention 1: Apixaban 2.5 mg tablet BID for 24 weeks intervention 2: Apixaban 5.0 mg tablet BID for 24 weeks intervention 3: Placebo tablet for 24 weeks
intervention 1: Apixaban intervention 2: Apixaban intervention 3: Placebo
18
Kasuga | Fukuoka | Japan | 130.4611 | 33.52594 Kitakyushu | Fukuoka | Japan | 130.85034 | 33.85181 Gifu | Gifu | Japan | 136.76039 | 35.42291 Hiroshima | Hiroshima | Japan | 132.45 | 34.4 Kure | Hiroshima | Japan | 132.56658 | 34.23222 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Kumamoto | Kumamoto | Japan | 130.691...
149
1
0.006711
1
NCT00852397
6TERMINATED
2010-12-01
2009-04-01
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
1
0
0
0
0
0
0
0
0.001186
[ 4 ]
248
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
null
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in ...
null
Gout
Intercritical Gout Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout
null
3
arm 1: Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15. arm 2: Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept...
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Placebo loading dose followed by placebo subcutaneous (SC) injection (2 mL) once a week for 16 weeks. intervention 2: Rilonacept 160 mg SC loading dose followed by Rilonacept 80 mg/2 mL SC injections once a week for 16 weeks. intervention 3: Rilonacept 320 mg SC loading dose followed by Rilonacept 160 m...
intervention 1: Placebo intervention 2: Rilonacept intervention 3: Rilonacept
61
Berlin | N/A | Germany | 13.41053 | 52.52437 Essen | N/A | Germany | 7.01228 | 51.45657 Goch | N/A | Germany | 6.15895 | 51.67873 Hamburg | N/A | Germany | 9.99302 | 53.55073 Kassel | N/A | Germany | 9.5 | 51.31667 Künzing | N/A | Germany | 13.08333 | 48.66667 Lollar | N/A | Germany | 8.70495 | 50.64652 Magdeburg | N/A...
248
12
0.048387
1
NCT00958438
1COMPLETED
2010-12-01
2009-07-01
Regeneron Pharmaceuticals
4INDUSTRY
false
false
false
null
0
12
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.027893
[ 4 ]
456
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
This trial is conducted in Asia, Europe, Japan and South America. The aim of the trial is to compare the efficacy, safety and tolerability of NN1250 (insulin degludec (\[Deg\]) with insulin detemir (IDet), both combined with insulin aspart. The main period is registered internally at Novo Nordisk as NN1250-3585 while ...
null
Diabetes Diabetes Mellitus, Type 1
null
2
arm 1: None arm 2: None
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Injected s.c. (under the skin) once daily. Dose was individually adjusted. intervention 2: Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted. intervention 3: Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
intervention 1: insulin degludec intervention 2: insulin detemir intervention 3: insulin aspart
69
Caba | N/A | Argentina | N/A | N/A Ciudad Autónoma de Bs As | N/A | Argentina | N/A | N/A Mar del Plata | N/A | Argentina | -57.5562 | -38.00042 Rosario | N/A | Argentina | -60.63932 | -32.94682 Porto Alegre | Rio Grande do Sul | Brazil | -51.23019 | -30.03283 São Paulo | São Paulo | Brazil | -46.63611 | -23.5475 Maríl...
453
1
0.002208
1
NCT01074268
1COMPLETED
2010-12-01
2010-02-01
Novo Nordisk A/S
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
1
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0.00039
[ 2, 3 ]
136
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
Phase I/II trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma. Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
OBJECTIVES: Phase 1 I. Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma. II. Determine the safety profile of this drug in these patients. III. Determine the pharmacokinetics of this drug in these patients. Phase 2 I. Determine the 6-...
Adult Anaplastic Astrocytoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Adult Grade I Meningioma Adult Grade II Meningioma Adult Grade III Meningioma Recurrent Adult Brain Tumor
null
2
arm 1: Phase I: Patients concurrently receiving EIAEDs receive oral erlotinib once daily. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is determined. The MTD is the dose ...
[ 0, 0 ]
3
[ 0, 10, 10 ]
intervention 1: given orally intervention 2: correlative studies intervention 3: correlative studies
intervention 1: erlotinib hydrochloride intervention 2: laboratory biomarker analysis intervention 3: pharmacological study
7
Los Angeles | California | United States | -118.24368 | 34.05223 San Francisco | California | United States | -122.41942 | 37.77493 Bethesda | Maryland | United States | -77.10026 | 38.98067 New York | New York | United States | -74.00597 | 40.71427 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Dalla...
131
0
0
0
NCT00045110
1COMPLETED
2010-12-01
2002-08-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
46
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as cisplatin, etoposide, and docetaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining cisplatin and etoposide with radiation therapy may shrink the tumor so it can b...
OBJECTIVES: * Determine the feasibility of administering induction chemoradiotherapy comprising cisplatin and etoposide followed by surgical resection and adjuvant docetaxel in patients with non-small cell lung cancer involving the superior sulcus (Pancoast tumors). * Determine overall survival of patients treated wit...
Lung Cancer
stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer
null
1
arm 1: None
[ 0 ]
5
[ 0, 0, 0, 3, 4 ]
intervention 1: During induction:50 mg/m2,IV on Days 1, 8, 29 \& 36. In any appropriate vehicle over 60 minutes intervention 2: During consolidation: 75 mg/m2 IV on Day 1, every 21 days for 3 cycles over 60 minutes intervention 3: During induction: 50 mg/m2, IV on Days 1 - 5 Days 29 - 33. In 250 ml of NS over 60 minute...
intervention 1: cisplatin intervention 2: docetaxel intervention 3: etoposide intervention 4: conventional surgery intervention 5: radiation therapy
154
Mobile | Alabama | United States | -88.04305 | 30.69436 Fort Collins | Colorado | United States | -105.08442 | 40.58526 Jacksonville | Florida | United States | -81.65565 | 30.33218 Aurora | Illinois | United States | -88.32007 | 41.76058 Joliet | Illinois | United States | -88.0834 | 41.52519 Maywood | Illinois | Unit...
95
0
0
0
NCT00062439
1COMPLETED
2010-12-01
2003-07-01
SWOG Cancer Research Network
5NETWORK
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
29
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
RATIONALE: Drugs used in chemotherapy, such as cisplatin and fluorouracil, use different ways to stop tumor cells from dividing so they stop growing or die. Biological therapies such as interferon alfa may interfere with the growth of the tumor cells and slow the growth of cancer. Radiation therapy uses high-energy x-r...
OBJECTIVES: Primary * Determine the overall survival of patients with previously resected pancreatic adenocarcinoma treated with postoperative cisplatin, interferon alfa, fluorouracil, and concurrent radiotherapy. * Determine the toxic effects of this regimen in these patients. Secondary * Determine the disease-spe...
Pancreatic Cancer
stage I pancreatic cancer stage II pancreatic cancer stage III pancreatic cancer adenocarcinoma of the pancreas
null
1
arm 1: Postoperative Cisplatin 30 mg/m\^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radia...
[ 0 ]
4
[ 2, 0, 0, 4 ]
intervention 1: 3 million units subcutaneously every other day (Monday, Wednesday and Friday) during Days 1-19 and 29-45, for 6 1/2 weeks totaling 17 doses. intervention 2: 30 mg/m\^2 IV over 60 minutes on days 1, 8, 15, 29, 36, 43 - weekly for total 6 doses, during 5 1/2 weeks radiation therapy. intervention 3: 175 mg...
intervention 1: Recombinant Interferon Alfa intervention 2: Cisplatin intervention 3: Fluorouracil intervention 4: Radiation Therapy
1
Houston | Texas | United States | -95.36327 | 29.76328
28
0
0
0
NCT00068575
1COMPLETED
2010-12-01
2002-05-01
M.D. Anderson Cancer Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
79
NON_RANDOMIZED
null
0TREATMENT
0NONE
false
0ALL
false
To determine the Maximum Tolerated Dose (MTD), the tolerability, and the initial safety profile of CMC-544 in subjects with B-cell Non-Hodgkin's Lymphoma (NHL).
null
Lymphoma, B-Cell
B-Cell Non-Hodgkin's Lymphoma
null
1
arm 1: Inotuzumab ozogamicin, iv, dose escalation and expanded cohort at 1.8mg/m2
[ 0 ]
1
[ 0 ]
intervention 1: CMC-544, IV, dose escalation trial
intervention 1: Inotuzumab ozogamicin [CMC-544]
22
Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Chicago | Illinois | United States | -87.65005 | 41.85003 Chicago | Illinois | U...
79
0
0
0
NCT00073749
1COMPLETED
2010-12-01
2003-08-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
54
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining gemcitabine with docetaxel may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with docetaxel in t...
OBJECTIVES: Primary * Determine the objective response rate in patients with recurrent osteosarcoma or Ewing's sarcoma or unresectable or locally recurrent chondrosarcoma treated with sequential gemcitabine and docetaxel. Secondary * Determine the time to progression in patients treated with this regimen. * Assess ...
Sarcoma
recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor chondrosarcoma recurrent osteosarcoma
null
0
null
null
7
[ 2, 2, 0, 0, 6, 10, 10 ]
intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: docetaxel intervention 4: gemcitabine hydrochloride intervention 5: microarray analysis intervention 6: laboratory biomarker analysis intervention 7: pharmacokinetic study
intervention 1: filgrastim intervention 2: pegfilgrastim intervention 3: docetaxel intervention 4: gemcitabine hydrochloride intervention 5: microarray analysis intervention 6: laboratory biomarker analysis intervention 7: pharmacokinetic study
0
null
53
0
0
0
NCT00073983
1COMPLETED
2010-12-01
2006-10-01
Sarcoma Alliance for Research through Collaboration
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 ]
17
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
RATIONALE: Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, etoposide phosphate, and cytarabine, use different ways to stop cance...
OBJECTIVES: Primary * Determine the efficacy of rituximab, carboplatin, cyclophosphamide, etoposide or etoposide phosphate and cytarabine administered in conjunction with osmotic blood-brain barrier disruption and high-dose sodium thiosulfate, in terms of complete response rate, in patients with refractory or recurre...
Brain and Central Nervous System Tumors Drug/Agent Toxicity by Tissue/Organ Lymphoma Thrombocytopenia
drug/agent toxicity by tissue/organ thrombocytopenia intraocular lymphoma primary central nervous system non-Hodgkin lymphoma primary central nervous system Hodgkin lymphoma
null
1
arm 1: None
[ 0 ]
9
[ 0, 0, 0, 0, 0, 0, 0, 0, 0 ]
intervention 1: Total dose: 375mg/m2 infused IV; Every 4 weeks for up to one year. intervention 2: Dose 330mg/m2 x 2 days infused IV; Every 4 weeks for up to 1 year intervention 3: Dose 200mg/m2 x 2 days infused IV; Every 4 weeks for up to one year. Etoposide phosphate may be given instead. intervention 4: Dose 200mg/m...
intervention 1: Rituxan intervention 2: Cyclophosphamide intervention 3: Etoposide intervention 4: Etoposide phosphate intervention 5: Carboplatin intervention 6: Sodium thiosulfate intervention 7: Neupogen intervention 8: Neulasta intervention 9: Cytarabine
2
Cincinnati | Ohio | United States | -84.51439 | 39.12711 Portland | Oregon | United States | -122.67621 | 45.52345
17
0
0
0
NCT00074165
6TERMINATED
2010-12-01
2003-01-01
OHSU Knight Cancer 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
[ 3 ]
11
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases...
Autoinflammatory diseases are illnesses characterized by episodes of inflammation that, unlike autoimmune disorders, lack the production of high titer autoantibodies or antigen-specific T cells. There is growing genetic and clinical evidence that Interleukin-1 (IL-1) plays a pathogenic role in several of these diseases...
Inflammation Familial Mediterranean Fever Still's Disease, Adult-Onset
Muckle Wells Syndrome NOMID Adult Stills Disease Familial Mediterranean Treatment Trial/Fever Autoinflammatory Disease
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: None
intervention 1: IL-1 Trap
1
Bethesda | Maryland | United States | -77.10026 | 38.98067
11
0
0
0
NCT00094900
1COMPLETED
2010-12-01
2004-10-01
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
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
PARALLEL
4SUPPORTIVE_CARE
2DOUBLE
false
0ALL
true
To evaluate whether palifermin (rHuKGF) administered as a single dose is non-inferior to 3 consecutive doses of palifermin in reducing the incidence of severe oral mucositis (World Health Organization \[WHO\] grade 3 and 4).
null
Cancer Lymphoma Leukemia
Cancer Oncology
null
4
arm 1: Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy wit...
[ 1, 0, 0, 0 ]
5
[ 0, 4, 0, 0, 0 ]
intervention 1: Administered as one daily intravenous bolus. intervention 2: To be delivered before the administration of chemotherapy in 6, 8, or 10 fractions over 3 or 4 days. intervention 3: Cyclophosphamide is administered at a total dose of 100 mg/kg given in 1 dose on Day -2 intervention 4: Etoposide may be admin...
intervention 1: palifermin intervention 2: Total Body Irradiation intervention 3: Cyclophosphamide intervention 4: Etoposide intervention 5: Placebo
0
null
46
0
0
0
NCT00109031
1COMPLETED
2010-12-01
2005-01-01
Swedish Orphan Biovitrum
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 ]
42
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES: I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib. SECONDARY OBJECTIVES: I. Determine the progression-free and overall survival of patients treated with this drug. II. ...
Adenocarcinoma of the Lung Bronchoalveolar Cell Lung Cancer Non-small Cell Lung Cancer Recurrent Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
null
1
arm 1: Patients receive bortezomib IV over 3-5 seconds on days 1 and 8.
[ 0 ]
1
[ 0 ]
intervention 1: Given IV
intervention 1: bortezomib
1
Duarte | California | United States | -117.97729 | 34.13945
42
0
0
0
NCT00118144
1COMPLETED
2010-12-01
2005-06-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
73
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
null
This phase II trial is studying how well giving combination chemotherapy together with rituximab and bevacizumab works in treating older patients with stage II, stage III, or stage IV diffuse large B-cell lymphoma. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing t...
PRIMARY OBJECTIVES: I. To estimate the 1-year progression-free survival rate in patients with advanced stage diffuse large B-cell NHL treated with CHOP - rituximab - bevacizumab. II. To estimate the response rate (complete, complete unconfirmed, and partial) and 2-year progression-free survival of this regimen in pat...
Contiguous Stage II Adult Diffuse Large Cell Lymphoma Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma Stage III Adult Diffuse Large Cell Lymphoma Stage IV Adult Diffuse Large Cell Lymphoma
null
1
arm 1: Patients receive rituximab IV, bevacizumab IV over 30-90 minutes, cyclophosphamide IV over 15 minutes, doxorubicin IV, and vincristine IV on day 1. Patients also receive oral prednisone on days 1-5. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
[ 0 ]
7
[ 2, 2, 0, 0, 0, 0, 10 ]
intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV intervention 5: Given IV intervention 6: Given PO intervention 7: Correlative studies
intervention 1: rituximab intervention 2: bevacizumab intervention 3: cyclophosphamide intervention 4: doxorubicin hydrochloride intervention 5: vincristine sulfate intervention 6: prednisone intervention 7: laboratory biomarker analysis
1
Portland | Oregon | United States | -122.67621 | 45.52345
63
0
0
0
NCT00121199
1COMPLETED
2010-12-01
2005-06-01
National Cancer Institute (NCI)
0NIH
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
134
RANDOMIZED
PARALLEL
1PREVENTION
0NONE
false
0ALL
true
The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).
BACKGROUND: Stroke occurs in 10% of children with SCA and has a very high risk of recurrence without therapy. Affected children receive chronic erythrocyte transfusions to prevent a secondary stroke, which are effective but have limited long-term utility due to transmission of infectious agents, erythrocyte alloantibo...
Hemochromatosis Cerebrovascular Accident Anemia, Sickle Cell Hematologic Diseases
Blood Diseases
null
2
arm 1: Hydroxyurea and phlebotomy arm 2: Transfusion and chelation
[ 1, 1 ]
4
[ 3, 3, 0, 3 ]
intervention 1: Red Blood Cell Transfusions intervention 2: Iron Chelation Therapy intervention 3: Hydroxyurea intervention 4: Phlebotomy
intervention 1: Red Cell Transfusions intervention 2: Iron Chelation intervention 3: Hydroxyurea intervention 4: Phlebotomy
28
Birmingham | Alabama | United States | -86.80249 | 33.52066 Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida | United States | -80.19366 | 25.77427 Orlando | Florida | United States | -81.37924 | 28.53834 Atlanta ...
133
0
0
0
NCT00122980
6TERMINATED
2010-12-01
2006-10-01
St. Jude Children's Research 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
[ 3 ]
65
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine if the investigators can predict the sensitivity or resistance of colon cancer to the two available first line chemotherapy agents.
Colorectal cancer is the third largest cause of cancer mortality in the United States. The treatment of metastatic colorectal cancer is undergoing rapid improvement. Currently, there are two major chemotherapy regimens, which can both be combined with anti-angiogenesis treatment. These regimens are 5-Fluorouracil (5-FU...
Adenocarcinoma Colon Cancer
colon adenocarcinoma adenocarcinoma-colon adenocarcinoma-rectum
null
2
arm 1: Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression arm 2: Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously a...
[ 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: XELOX: Oxaliplatin 130 mg/m\^2 intravenously (IV); Capecitabine 825 mg/m\^2 by mouth (po) intervention 2: XELIRI: Irinotecan 240 mg/m\^2 IV; Capecitabine 825 mg/m\^2 by mouth (po) intervention 3: 7.5 mg/kg intravenously (IV)
intervention 1: XELOX intervention 2: XELIRI intervention 3: Bevacizumab
12
Deerfield Beach | Florida | United States | -80.09977 | 26.31841 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Fort Myers | Florida | United States | -81.84059 | 26.62168 Lakeland | Florida | United States | -81.9498 | 28.03947 Port Charlotte | Florida | United States | -82.09064 | 26.97617 Stuart | ...
65
0
0
0
NCT00127036
6TERMINATED
2010-12-01
2003-10-01
H. Lee Moffitt Cancer Center and 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 ]
47
RANDOMIZED
FACTORIAL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The purpose of this study is to determine whether methylphenidate is an effective treatment for depression and to document the safety and tolerability of methylphenidate in combination with an Selective Serotonin Reuptake Inhibitor (SSRI) in SSRI treated, terminally ill, hospice and palliative care cancer patients. The...
Background: Major depressive disorder can be diagnosed in between 5% and 26% of terminally ill patients. This disorder causes suffering, and is associated with suicidality, increased pain, and increased caregiver burden and caregiver depression. Treatment of depression in cancer patients in hospice and palliative care ...
Depression Palliative Care Cancer Mental Disorder
Depression Hospice Care Antidepressive Agents Methylphenidate Central Nervous System Stimulant Pain Caregiver Burden Cancer
null
2
arm 1: During the 18-day blind treatment period, subjects will be prescribed methylphenidate 5-10 mg twice per day and selective serotonin reuptake inhibitor (SSRI). Subjects already receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not receiving a SSRI will be pre...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Subjects will take methylphenidate 5 mg twice daily (bid) for 3 days, then 10 mg bid for the remainder of the study. Should a subject have a 50% decrease in their depressive symptoms as measured by the Montgomery Asberg Depression Rating Scale (MADRS) at the initial dose of methylphenidate, they will be...
intervention 1: Methylphenidate intervention 2: Placebo intervention 3: Selective Serotonin Uptake Inhibitor (SSRI)
1
Portland | Oregon | United States | -122.67621 | 45.52345
32
0
0
0
NCT00129467
1COMPLETED
2010-12-01
2005-02-01
US Department of Veterans Affairs
1FED
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
123
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
The purpose of this study is to determine if Venlafaxine Extended Release (Ven-XR) is effective in treating individuals with marijuana addiction and depression.
Given that depression and marijuana addiction often occur together, medications to treat individuals diagnosed with both conditions may be effective. The purpose of this study is to determine the effectiveness of Ven-XR in treating individuals diagnosed with depression and marijuana addiction. During this twelve-week,...
Depression Marijuana Abuse
cannabis dependence depression treatment venlafaxine
null
2
arm 1: Venlafaxine arm 2: Placebo
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 375mg/day intervention 2: Placebo
intervention 1: Venlafaxine intervention 2: Placebo
1
New York | New York | United States | -74.00597 | 40.71427
103
0
0
0
NCT00131456
1COMPLETED
2010-12-01
2004-03-01
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