FEATURE_phases
list
FEATURE_enrollmentCount
int64
FEATURE_allocation
string
FEATURE_interventionModel
string
FEATURE_primaryPurpose
class label
FEATURE_masking
class label
FEATURE_healthyVolunteers
bool
FEATURE_sex
class label
FEATURE_oversightHasDmc
bool
FEATURE_briefSummary
string
FEATURE_detailedDescription
string
FEATURE_conditions
string
FEATURE_conditionsKeywords
string
FEATURE_protocolPdfText
string
FEATURE_numArms
int64
FEATURE_armDescriptions
string
FEATURE_armGroupTypes
list
FEATURE_numInterventions
int64
FEATURE_interventionTypes
list
FEATURE_interventionDescriptions
string
FEATURE_interventionNames
string
FEATURE_numLocations
int64
FEATURE_locationDetails
string
LABEL_ct_level_ade_population
int64
LABEL_sum_dosing_errors
int64
LABEL_dosing_error_rate
float32
LABEL_wilson_label
int64
METADATA_nctId
string
METADATA_overallStatus
class label
METADATA_completionDate
date32
METADATA_startDate
date32
METADATA_leadSponsorName
string
METADATA_leadSponsorClass
class label
METADATA_hasProtocol
bool
METADATA_hasSap
bool
METADATA_hasIcf
bool
METADATA_protocolPdfLinks
string
METADATA_count_Accidental drug intake by child
int64
METADATA_count_Accidental overdose
int64
METADATA_count_Accidental overdose (therapeutic agent)
int64
METADATA_count_Accidental underdose
int64
METADATA_count_Deliberate overdose
int64
METADATA_count_Dose calculation error
int64
METADATA_count_Drug administration error
int64
METADATA_count_Drug overdose
int64
METADATA_count_Drug overdose accidental
int64
METADATA_count_Extra dose administered
int64
METADATA_count_Incorrect dosage administered
int64
METADATA_count_Incorrect dose administered
int64
METADATA_count_Incorrect drug administration duration
int64
METADATA_count_Incorrect drug administration rate
int64
METADATA_count_Incorrect product administration duration
int64
METADATA_count_Intentional overdose
int64
METADATA_count_Medication error
int64
METADATA_count_Medication monitoring error
int64
METADATA_count_Multiple drug overdose
int64
METADATA_count_Multiple drug overdose accidental
int64
METADATA_count_Multiple drug overdose intentional
int64
METADATA_count_Multiple use of single-use product
int64
METADATA_count_Non-accidental overdose
int64
METADATA_count_Overdose
int64
METADATA_count_Overdose NOS
int64
METADATA_count_Overmedication
int64
METADATA_count_Prescribed overdose
int64
METADATA_count_Treatment noncompliance
int64
METADATA_count_Underdose
int64
METADATA_count_Unintentional medical device removal
int64
METADATA_count_Unintentional medical device removal by patient
int64
METADATA_wilson_lower_bound
float32
[ 4 ]
18
NA
SINGLE_GROUP
1PREVENTION
0NONE
true
1FEMALE
false
The purpose of this research is to establish if a once a year dose of Zoledronic Acid is sufficient to suppress and maintain urine and serum bone density markers (NTx) and serum CTx within normal range at 12 months post-dosing in postmenopausal early breast cancer patients receiving additional treatment with non-steroi...
Bone metastases are frequently one of the first signs of disseminated disease in cancer patients. Skeletal complications due to metastatic disease include (severe) bone pain, spinal cord compromise, pathological fractures, and hypercalcemia. Zoledronic acid is a member of a class of compounds known as bisphosphonates....
Breast Cancer
Breast cancer aromatase inhibitors
null
1
arm 1: Zometa (Zoledronic Acid) 5 mg IV X 1 dose
[ 0 ]
1
[ 0 ]
intervention 1: Zometa (Zoledronic Acid) 5 mg IV over 15 minutes in a one time dose
intervention 1: Zometa
1
Hershey | Pennsylvania | United States | -76.65025 | 40.28592
17
0
0
0
NCT00712985
1COMPLETED
2011-03-01
2005-09-01
Milton S. Hershey Medical Center
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
55
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This is a phase 2, two-arm, non-randomized, open-label, multicenter study evaluating the safety and efficacy of 2 VELCADE-containing regimens. Patients will be treated with either a combination of VELCADE, rituximab, cyclophosphamide, doxorubicin, and prednisone (VELCADE-R-CAP) or a combination of VELCADE, rituximab, c...
null
Relapsed Follicular Lymphoma
null
2
arm 1: VELCADE will be administered as a 3- to 5-second intravenous bolus injection, rituximab 375 mg/m2 Intravenous on Day 1, cyclophosphamide 750 mg/m2 intravenous on Day 1, doxorubicin 50 mg/m2 intravenous on Day 1, VELCADE 1.6 mg/m2 intravenous on Days 1 and 8, prednisone 100 mg orally on Days 1 to 5 of a 21-day (3...
[ 0, 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None
intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: doxorubicin intervention 4: VELCADE intervention 5: prednisone
43
Muscle Shoals | Alabama | United States | -87.66753 | 34.74481 Burbank | California | United States | -118.30897 | 34.18084 Fountain Valley | California | United States | -117.95367 | 33.70918 Loma Linda | California | United States | -117.26115 | 34.04835 Rancho Mirage | California | United States | -116.41279 | 33.73...
55
0
0
0
NCT00715208
1COMPLETED
2011-03-01
2008-09-01
Millennium 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
[ 4 ]
1,648
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis.
The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be ...
Rheumatoid Arthritis
Certolizumab pegol Cimzia Rheumatoid Arthritis Joint Disease Chronic Arthritis
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 400 mg CZP given as two 200 mg subcutaneous (sc) injections at Weeks 0, 2, and 4, followed by 200 mg CZP given as 1 sc injection on Weeks 6, 8, and 10. At Week 12 subjects enter the open label phase and receive 200 mg of CZP every other week for a minimum 16 additional weeks until CZP is commercially av...
intervention 1: Certolizumab pegol (CZP) intervention 2: Placebo
181
Birmingham | Alabama | United States | -86.80249 | 33.52066 Montgomery | Alabama | United States | -86.29997 | 32.36681 Phoenix | Arizona | United States | -112.07404 | 33.44838 Tucson | Arizona | United States | -110.92648 | 32.22174 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Little Rock | Arkansas |...
2,009
0
0
0
NCT00717236
1COMPLETED
2011-03-01
2008-07-01
UCB Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
3
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
1FEMALE
true
This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia. Special placental cells call...
Preeclampsia
preeclampsia progesterone aspirin prevent soluble fms-like tyrosine kinase (sFlt-1) Placental Growth Factor (PlGF) risk
null
2
arm 1: Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day arm 2: Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
[ 2, 1 ]
3
[ 0, 0, 0 ]
intervention 1: Aspirin 81 mg once a day intervention 2: Placebo 1 tab Daily intervention 3: Oral Progesterone 200 mg Twice Daily
intervention 1: Aspirin intervention 2: Placebo Oral Tablet intervention 3: Progesterone
1
Royal Oak | Michigan | United States | -83.14465 | 42.48948
3
0
0
0
NCT00719537
6TERMINATED
2011-03-01
2008-07-01
John Uckele
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3, 4 ]
84
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
Lumbosacral radiculopathy is one of the leading of cause of disability in the U.S. and worldwide. Among recent reviews evaluating epidural steroid injections, some 1 but not all 2 concluded them to be effective in the long-term. In our own double-blind, placebo-controlled study evaluating epidural etanercept, the resul...
This is a 3-arm multi-center, randomized, double-blind, placebo-controlled study comparing two treatments with transforaminal epidural saline. Each group will receive a 2nd procedure identical to the first 2 weeks after the initial procedure. Seventy-eight study participants will be randomized via a computerized rando...
Lumbosacral Radiculopathy
radiculopathy sciatica low back pain
null
3
arm 1: Epidural etanercept 4 mg, two doses 2 weeks apart arm 2: Epidural methylprednisolone 60 mg, two doses 2 weeks apart arm 3: Epidural saline, two doses 2 weeks apart
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Two transforaminal epidural injections of 4 mg, two weeks apart intervention 2: Two transforaminal epidural steroid injections with 60 mg, two weeks apart intervention 3: Two transforaminal epidural saline injections, two weeks apart
intervention 1: etanercept intervention 2: methylprednisolone intervention 3: normal saline
2
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511 Fort Bragg | North Carolina | United States | -79.00603 | 35.139
84
0
0
0
NCT00733096
1COMPLETED
2011-03-01
2008-08-01
Johns Hopkins University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
24
NA
SINGLE_GROUP
null
0NONE
false
0ALL
false
The purpose of this research study is to learn about the effects of a medication called Vyvanse on the heart (cardiovascular system). The U.S. Food and Drug Administration (FDA) has approved Vyvanse for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). People who have ADHD have trouble paying attention,...
null
Attention Deficit Hyperactivity Disorder (ADHD)
cardiovascular testing home blood pressure monitoring office home blood pressure monitoring cardiopulmonary exercise testing transthoracic echocardiography Lisdexamfetamine Vyvanse normotensive and hypertensive adults with ADHD ADHD medication.
null
1
arm 1: Adults who meet DSM-IV-TR criteria for ADHD. Group 1 is normotensive adults; Group 1 does not have high blood pressure. Group 2 is primary hypertensive adults; Group 2 does have high blood pressure and is being treated with stable doses of hypertensive medications achieving a blood pressure of \<135/85.
[ 0 ]
1
[ 0 ]
intervention 1: Lisdexamfetamine daily until the completion of participation in the clinical trial (up to Week 11 or final study visit). Subjects will start on 30 mg of LDX per day for the first week of treatment. The dose will be increased weekly in 20 mg increments, up to a 70 mg daily (maximum). If significant adver...
intervention 1: Lisdexamfetamine
1
Cambridge | Massachusetts | United States | -71.10561 | 42.3751
22
0
0
0
NCT00753012
1COMPLETED
2011-03-01
2008-04-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
56
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
This research project will determine the safety and tolerability of ginseng in subjects with MS and will gather preliminary data on the efficacy of ginseng vs placebo for the treatment of MS fatigue.
Fatigue is a major cause of disability in MS and is associated with a reduced quality of life. Treatment options for MS fatigue include central nervous system stimulants and amantadine. These medications are of limited efficacy, are often poorly tolerated, and can be expensive. Ginseng may represent a novel approach to...
Multiple Sclerosis
Multiple sclerosis fatigue ginseng
null
2
arm 1: Period 1 with Ginseng therapy intervention; Washout Period with no drug; Period 2 with placebo arm 2: Period 1 with placebo; Washout period with no drug; Period 2 with ginseng therapy intervention
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Ginseng HT-1001 was dosed at 100 mg orally per day initially, increased after one week to 200 mg per day, then further increased the next week to 400 mg per day as tolerated. Subjects were then maintained on 400 mg per day or the maximum tolerated dose for the remainder of the 6 week treatment period. i...
intervention 1: American ginseng extract HT-1001 intervention 2: placebo
1
Portland | Oregon | United States | -122.67621 | 45.52345
112
0
0
0
NCT00754832
1COMPLETED
2011-03-01
2005-09-01
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
[ 2 ]
27
RANDOMIZED
CROSSOVER
9OTHER
4QUADRUPLE
false
1FEMALE
false
The purpose of this study is to explore how pregabalin works in patients with fibromyalgia by evaluating brain imaging signals. To find out whether fMRI (functional magnetic resonance imaging) is an efficient way to show whether new pain medications are effective in treating fibromyalgia.
Methodology study
Fibromyalgia
Fibromyalgia; fMRI; pain; pregabalin; Lyrica; imaging
null
2
arm 1: None arm 2: None
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo and pregabalin will be given orally twice daily in capsules at different times during the course of the study. The highest dose of pregabalin to be used in the study is 450 mg/day. intervention 2: Placebo and pregabalin will be given orally twice daily in capsules at different times during the c...
intervention 1: Pregabalin, then placebo intervention 2: Placebo, then pregabalin
2
Ann Arbor | Michigan | United States | -83.74088 | 42.27756 Ann Arbor | Michigan | United States | -83.74088 | 42.27756
49
0
0
0
NCT00760474
1COMPLETED
2011-03-01
2009-01-01
Pfizer's Upjohn has merged with Mylan to form Viatris 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 ]
60
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators hypothesize there will be secondary improvemen...
OBJECTIVE: To evaluate if Sensoril® treatment of persons with bipolar illness will improve their cognitive performance and if it will improve residual mood/anxiety symptoms and impaired metabolic indices. RESEARCH PLAN: We will conduct a randomized, placebo controlled, add on treatment trial of Sensoril® (added to o...
Bipolar I Disorder Bipolar II Disorder Bipolar Disorder NOS
Sensoril Bipolar Illness Cognitive enhancement
null
2
arm 1: Sensoril (Ashwagandha) will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week. arm 2: Placebo will be administered using random assignment at a dose of 250 mg/day, increasing to a dose of 500 mg/day by the second week.
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: None intervention 2: None
intervention 1: Sensoril intervention 2: Placebo
2
Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062 Pittsburgh | Pennsylvania | United States | -79.99589 | 40.44062
60
0
0
0
NCT00761761
1COMPLETED
2011-03-01
2008-10-01
University of Pittsburgh
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 1 ]
14
RANDOMIZED
CROSSOVER
2DIAGNOSTIC
1SINGLE
false
0ALL
false
The goal of this research is to determine the utility of Regadenoson (Lexiscan)for use as an imaging agent with cardiac MR. If found useful, it will help us establish a protocol for regadenoson stress MR perfusion (Regadenoson stress test with cardiac MR).The investigators will compare regadenoson with dobutamine so ea...
null
Coronary Artery Disease Asthma Chronic Obstructive Pulmonary Disease (COPD) Angina
Coronary Artery Disease Coronary Vessels Myocardial Ischemia Coronary Disease Ischemic heart disease asthma copd
null
2
arm 1: Arm A will get Dobutamine Stress test with cardiac MR (CMR). Both arms will then cross over to the other arm to get the second test. So each participant will undergo two types of testing. arm 2: Arm B will get Regadenoson stress test with CMR. Both arms will then cross over to the other arm to get the second tes...
[ 1, 1 ]
2
[ 0, 0 ]
intervention 1: Each participant will receive regadenoson 0.4mg (5ml) one time bolus dose at one visit. intervention 2: Each participant will receive dobutamine infusion (as per protocol to achieve a target heart rate of 85% of predicted for age) at another visit.
intervention 1: Regadenoson intervention 2: Dobutamine
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
12
0
0
0
NCT00763035
6TERMINATED
2011-03-01
2009-01-01
Wake Forest University Health Sciences
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to determine the effectiveness of a particular combination of drugs used to treat cancer.
null
Myelodysplastic Syndrome Acute Myeloid Leukemia
Therapy-related myelodysplastic syndrome/ Therapy -related Acute myeloid leukemia Myelodysplastic syndrome Acute myeloid leukemia
null
1
arm 1: Ara-C Mitoxantrone Etoposide Stem cell mobilization Autologous transplant
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Induction: 3000mg/m2 IV infusion for day 1 and day 5 Mobilization: within 2 weeks of end of induction therapy - 2000mg/m2 as 2 hour IV infusion once every 12 hours for 3 days (6 doses total) intervention 2: Induction: 30mg/m2 after the end of HiDAC day 1 and day 5 intervention 3: Mobilization: 30mg/kg ...
intervention 1: Ara-C intervention 2: Mitoxantrone intervention 3: Etoposide
1
Chicago | Illinois | United States | -87.65005 | 41.85003
32
0
0
0
NCT00774046
1COMPLETED
2011-03-01
2002-12-01
University of Chicago
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 ]
371
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes
null
Type 2 Diabetes Mellitus
null
3
arm 1: Normal Weight by Body Weight Index arm 2: Overweight by Body Weight Index arm 3: Obese by Body Weight Index
[ 0, 0, 0 ]
1
[ 0 ]
intervention 1: Tablets, Oral, 500mg tid, 1500 mg/day, 16 weeks
intervention 1: Metformin XR
14
Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beijing Municipality | China | 116.39723 | 39.9075 Beijing | Beiji...
371
0
0
0
NCT00778622
1COMPLETED
2011-03-01
2009-11-01
Bristol-Myers Squibb
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
8
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This research study is being performed at approximately 3 sites associated with Accelerated Community Oncology Research Network, Inc. (ACORN). Approximately 45 subjects will take part in this study. In this study, everyone will receive the same dose of mFOLFOX6 and Avastin. There will be five groups of subjects. Each ...
This is an investigator-initiated, multicenter, network, Phase 1, open-label, dose-ranging study. The maximum sample size will be 45 patients (up to 30 patients for determining MTD at Phase I, and an additional 15 patients to provide for estimate of progression free survival). All eligible patients will receive the mFO...
Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
null
1
arm 1: All eligible patients will receive the mFOLFOX6 regimen at full dose followed by IV bevacizumab 5mg/kg on Day 1 of each treatment cycle. Sorafenib will be administered daily throughout treatment beginning on day 1
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: Sorafenib will be administered daily starting day 1 at 200mg QOD at Dose Level 1; 200mg/day at Dose Level 2; 200mg BID (5 days on/ 2 days off) at Dose Level 3; 200mg BID at Dose Level 4; and 400mg BID at Dose Level 5. intervention 2: Bevacizumab will be administered as 5mg/kg IV on Day 1 of each treatme...
intervention 1: sorafenib intervention 2: bevacizumab intervention 3: mFOLFOX6 regimen
3
Macon | Georgia | United States | -83.6324 | 32.84069 Billings | Montana | United States | -108.50069 | 45.78329 Memphis | Tennessee | United States | -90.04898 | 35.14953
8
0
0
0
NCT00779311
6TERMINATED
2011-03-01
2008-10-01
Accelerated Community Oncology Research Network
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 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study combines nelfinavir (NFV) with radiation therapy and chemotherapy as a treatment for non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment.
This is a phase 2 trial of the HIV protease inhibitor (HPI) Nelfinavir (NFV) in combination with radiotherapy and chemotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) who are considered candidates for pre-operative treatment. This study is to be conducted according to US and international s...
Carcinoma, Non-Small-Cell Lung
NSCLC chemotherapy radiation therapy nelfinavir NFV
null
1
arm 1: None
[ 0 ]
1
[ 0 ]
intervention 1: 1250 mg twice daily starting for approximately 6.5 weeks.
intervention 1: Nelfinavir
1
Iowa City | Iowa | United States | -91.53017 | 41.66113
1
0
0
0
NCT00791336
6TERMINATED
2011-03-01
2008-08-01
University of Iowa
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 ]
183
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
This protocol is for subjects with pulmonary arterial hypertension and is the first of 3 studies forming the Sitaxsentan efficacy and safety trial with Randomized Prospective Assessment of Adding Sildenafil (SR-PAAS) program.
null
Pulmonary Arterial Hypertension Pulmonary Hypertension
Sitaxsentan endothelin receptor antagonist
null
2
arm 1: Monotherapy arm 2: Monotherapy
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily intervention 2: Sitaxsentan Placebo = 1 tablet administered orally, once daily
intervention 1: Sitaxsentan intervention 2: Placebo
85
Fountain Valley | California | United States | -117.95367 | 33.70918 Mather | California | United States | -119.85573 | 37.88215 Sacramento | California | United States | -121.4944 | 38.58157 Englewood | Colorado | United States | -104.98776 | 39.64777 Littleton | Colorado | United States | -105.01665 | 39.61332 Gaines...
182
0
0
0
NCT00795639
6TERMINATED
2011-03-01
2008-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
131
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
As monotherapy for pulmonary arterial hypertension (PAH) begins to fail additional therapies are introduced. Although co-administration of sitaxsentan and sildenafil is well tolerated the controlled safety/efficacy database of the combination is limited.
null
Pulmonary Arterial Hypertension Pulmonary Hypertension
endothelin receptor antagonist (ETRA) Sitaxsentan
null
2
arm 1: Monotherapy arm arm 2: Combination treatment
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Sitaxsentan = 100 mg tablet administered orally, once daily Sildenafil placebo = 1 tablet administered orally, three times a day intervention 2: Sitaxsentan = 100 mg tablet administered orally, once daily plus Sildenafil = 20 mg tablet administered orally, three times a day
intervention 1: Sitaxsentan intervention 2: Sitaxsentan and Sildenafil
48
Fountain Valley | California | United States | -117.95367 | 33.70918 Gainesville | Florida | United States | -82.32483 | 29.65163 Weston | Florida | United States | -80.39977 | 26.10037 Boston | Massachusetts | United States | -71.05977 | 42.35843 Omaha | Nebraska | United States | -95.94043 | 41.25626 Chapel Hill | No...
130
0
0
0
NCT00796666
6TERMINATED
2011-03-01
2009-05-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
5
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to assess the 2-month progression-free survival in patients with advanced or metastatic, non-squamous cell lung cancer treated with weekly low dose docetaxel in combination with a biologic dose of sorafenib.
The median survival of untreated advanced stage NSCLC is 5-6 months (2,3). Patients with poor performance status due to malignancy or co-morbidities have a poorer survival. This group of patients is underrepresented in clinical trials and may not receive chemotherapy due to fear of increased toxicities with systemic ch...
Non Squamous Cell Lung Cancer Non Small Cell Lung Cancer
Docetaxel Sorafenib
null
1
arm 1: Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy. Subjects will be treated with metronomic chemotherapy with low do...
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluat...
intervention 1: Docetaxel + Sorafenib
1
Birmingham | Alabama | United States | -86.80249 | 33.52066
5
0
0
0
NCT00801801
6TERMINATED
2011-03-01
2008-01-01
Francisco Robert,MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
3
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
Pilot study, Open-label, Phase II study of Everolimus. Objective: To determine if Everolimus can diminish large gastrointestinal polyps in patients with Peutz-Jeghers Syndrome. Methodology: Polyp size and number will be compared to baseline by FDG-PET and CT and 12 months after treatment with Everolimus. Since this...
Peutz-Jeghers Syndrome is a hereditary polyposis condition in which hamartomatous tumors develop in many tissues of the body. These tumors are benign but frequently cause gastrointestinal obstruction and bleeding beginning in the 2nd-3rd decades of life necessitating surgical intervention. Unfortunately, a recent study...
Peutz-Jeghers Syndrome
Cancer Polyps
null
1
arm 1: All participants enrolled.
[ 0 ]
1
[ 0 ]
intervention 1: Everolimus is a novel derivative of rapamycin. Everolimus has been in clinical development since 1996 as an immunosuppressant in solid organ transplantation. Since 2003, RAD001 is approved in Europe (trade name: Certican) via the Mutual Recognition Procedure (MRP) for the prevention of organ rejection i...
intervention 1: Everolimus
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
3
0
0
0
NCT00811590
6TERMINATED
2011-03-01
2008-11-01
University of Utah
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 ]
4
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to evaluate the safety and efficacy of Irinotecan Bead in combination with intravenous chemotherapy versus intravenous chemotherapy alone in the treatment of unresectable liver metastases in patients with colorectal cancer. The results of this study are intended to be used in supp...
There are many treatments for metastatic colorectal cancer to the liver, and both the application and outcomes are highly dependant on the patients disposition. Whilst resection results in the best long term survival, it is often not a viable treatment option. Irinotecan Bead is an embolization device intended to trea...
Unresectable Metastatic Colo-rectal Cancer
Cancer Carcinoma Colon Cancer Colorectal Cancer Gastric Cancer Gastrointestinal Cancer Metastases Metastatic Cancer Metastatic Colorectal Cancer Oncology Rectal Cancer
null
2
arm 1: Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm) arm 2: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
[ 0, 1 ]
2
[ 3, 0 ]
intervention 1: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule intervention 2: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks
intervention 1: Chemoembolization with irinotecan Bead intervention 2: Irinotecan
3
Aurora | Colorado | United States | -104.83192 | 39.72943 Chicago | Illinois | United States | -87.65005 | 41.85003 Burlington | Massachusetts | United States | -71.19561 | 42.50482
4
0
0
0
NCT00816777
6TERMINATED
2011-03-01
2008-12-01
Generic Devices Consulting, Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
39
RANDOMIZED
PARALLEL
6HEALTH_SERVICES_RESEARCH
1SINGLE
false
0ALL
false
The purpose of this research study is to find out if a test can predict whether someone with depression will get better with treatment. We also want to find out whether there are changes in the brains of depressed patients having different types of treatment (drug therapy vs. talk therapy). We hope that a test called Q...
To our knowledge, QEEG has not been studied in the prediction of response to CBT, an important and widely used non-pharmacologic approach to treating depression. Establishing QEEG technology as a predictor of response to CBT could help to guide treatment selection for individual patients. It is probable that certain pa...
Major Depressive Disorder
Major Depressive Disorder (MDD) Cognitive Behavioral Therapy (CBT) Escitalopram Quantitative EEG (QEEG)
Prot_000.pdf: Version Date: 11/30/09 1 QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression Principal Investigator: Amy Farabaugh, PhD I. Background and significance A. Treatment of MDD: Over two-thirds of patients with MDD treated with first-line medications, such ...
2
arm 1: CBT is a manualized therapeutic treatment for depression based on principles of cognitive restructuring and behavioral changes. arm 2: Escitalopram or Lexapro is a Selective Serotonin Reuptake Inhibitor (SSRI) used to treat depression
[ 1, 1 ]
2
[ 5, 0 ]
intervention 1: The CBT group will receive weekly 50-minute individual sessions over the course of 12 weeks conducted by experienced therapists who are trained in manual based CBT. intervention 2: The medication group will receive open label treatment of escitalopram, 10-20 mg/day, flexible dose, for 12 weeks, and will...
intervention 1: Cognitive Behavioral Therapy (CBT) intervention 2: Escitalopram
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
39
0
0
0
NCT00824044
1COMPLETED
2011-03-01
2008-07-01
Massachusetts General Hospital
7OTHER
true
true
false
https://cdn.clinicaltrials.gov/large-docs/44/NCT00824044/Prot_000.pdf https://cdn.clinicaltrials.gov/large-docs/44/NCT00824044/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 ]
717
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate...
null
Rheumatoid Arthritis
oral DMARD JAK inhibitor clinical trial
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 2, 2, 1 ]
5
[ 0, 0, 10, 10, 2 ]
intervention 1: tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months intervention 2: tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months intervention 3: placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months intervent...
intervention 1: CP 690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: Placebo intervention 5: Biologic TNFi
125
Gilbert | Arizona | United States | -111.78903 | 33.35283 Glendale | Arizona | United States | -112.18599 | 33.53865 Mesa | Arizona | United States | -111.82264 | 33.42227 Paradise Valley | Arizona | United States | -111.94265 | 33.53115 Phoenix | Arizona | United States | -112.07404 | 33.44838 Jonesboro | Arkansas | U...
2,151
0
0
0
NCT00853385
1COMPLETED
2011-03-01
2009-05-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
808
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to determine the efficacy of switching to a combination tablet ezetimibe/simvastatin (10mg/20mg) versus rosuvastatin (10 mg) versus doubling the statin dose in those patients who have cardiovascular disease and diabetes mellitus not adequately controlled on simvastatin 20 mg or atorvastatin...
null
Cardiovascular Disorder Diabetes Mellitus
cardiovascular disorder
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks. intervention 2: simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks. intervention 3: rosuvastatin 10 mg tablets, taken once daily for six weeks. intervention 4: All patients will take atorvastatin 10 mg t...
intervention 1: ezetimibe (+) simvastatin intervention 2: simvastatin 40 mg or atorvastatin 20 mg intervention 3: Rosuvastatin intervention 4: atorvastatin 10 mg or simvastatin 20 mg
0
null
806
0
0
0
NCT00862251
1COMPLETED
2011-03-01
2009-04-01
Organon and Co
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
107
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The main purpose of this study is to determine whether the combination of pazopanib and pemetrexed is safe and effective in the treatment of advanced non-small cell lung cancer (NSCLC).
null
Lung Cancer, Non-Small Cell
GW786034 pazopanib pemetrexed cisplatin non-small cell lung cancer NSCLC
null
2
arm 1: Investigational treatment (pazopanib and pemetrexed) arm 2: Standard treatment (pemetrexed and cisplatin)
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: oral pazopanib 600 mg once daily and pemetrexed intravenous (IV) 500mg/m\^2 once every 3 weeks, then pazopanib 800 mg once daily intervention 2: pemetrexed IV 500 mg/m\^2 and cisplatin IV 75 mg/m\^2 once every 3 weeks
intervention 1: pazopanib and pemetrexed intervention 2: pemetrexed and cisplatin
2
Herlev | N/A | Denmark | 12.43998 | 55.72366 Sutton | Surrey | United Kingdom | -0.2 | 51.35
103
0
0
0
NCT00871403
1COMPLETED
2011-03-01
2009-07-01
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 ]
8
NA
SINGLE_GROUP
null
0NONE
false
0ALL
false
Critically ill patients in the intensive care unit often receive continuous hemodialysis to treat their kidney failure. Ertapenem is an antibiotic often used in these patients. Continuous dialysis may remove ertapenem, putting patients at risk for inappropriate treatment of their infection. This study will determine ho...
Subjects receiving CVVHD will receive a one gram dose of ertapenem. Serial blood samples over 24 hours will be taken to assess the ertapenem blood concentrations over time. Spent dialysate and urine samples (if any) will also be measured for ertapenem content to determine how much drug is removed by CVVHD and kidneys. ...
Acute Kidney Failure
ertapenem continuous hemodialysis pharmacokinetics
null
1
arm 1: subjects will receive ertapenem while receiving CVVHD
[ 0 ]
1
[ 0 ]
intervention 1: One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood s...
intervention 1: ertapenem
1
Ann Arbor | Michigan | United States | -83.74088 | 42.27756
8
0
0
0
NCT00877370
1COMPLETED
2011-03-01
2009-02-01
University of Michigan
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 ]
421
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.
null
Acute Bipolar Depression
Acute bipolar depression Lithium carbonate quetiapine fumarate MADRS
null
2
arm 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. arm 2: Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. intervention 2: Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within t...
intervention 1: Quetiapine fumarate XR intervention 2: Lithium carbonate
24
La Plata | Buenos Aires | Argentina | -57.95442 | -34.92126 Godoy Cruz | Mendoza Province | Argentina | -68.84428 | -32.92533 Mendoza | Mendoza Province | Argentina | -68.84582 | -32.88946 Caba | N/A | Argentina | N/A | N/A Aparecida de Goiânia | Goiás | Brazil | -49.24389 | -16.82333 Rio de Janeiro | Rio de Janeiro | ...
421
0
0
0
NCT00883493
1COMPLETED
2011-03-01
2009-04-01
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 ]
182
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
false
This was a Phase 3b clinical study in prostate cancer patients which aimed to compare the current standard therapy of a gonadotrophin releasing hormone (GnRH) agonist, goserelin (3.6 mg; plus anti-androgen flare protection, bicalutamide), to a novel GnRH antagonist, degarelix (240 mg starting dose/80 mg maintenance dos...
null
Prostate Cancer
null
2
arm 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 an...
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on D...
intervention 1: Degarelix intervention 2: Goserelin intervention 3: Bicalutamide
46
Bruges | N/A | Belgium | 3.22424 | 51.20892 Brussels | N/A | Belgium | 4.34878 | 50.85045 Leuven | N/A | Belgium | 4.70093 | 50.87959 Turnhout | N/A | Belgium | 4.94471 | 51.32254 Aalborg | N/A | Denmark | 9.9187 | 57.048 Aarhus | N/A | Denmark | 10.21076 | 56.15674 Ballerup Municipality | N/A | Denmark | 12.36328 | 55...
182
0
0
0
NCT00884273
1COMPLETED
2011-03-01
2009-08-01
Ferring Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
20
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This multicenter, open-label study is designed to assess safety, dose-response using pharmacokinetic (PK) and pharmacodynamic (PD) measures, and clinical efficacy of BMN 110 in subjects between 5 and 18 years of age, diagnosed with Mucopolysaccharidosis IVA (MPS IVA).
null
MPS IV A
Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase N-acetylgalactosamine-6-sulfate sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT
null
1
arm 1: Within-patient Dose-Escalation
[ 0 ]
1
[ 0 ]
intervention 1: Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen: * Weeks 1-12: 0.1 mg/kg/week * Weeks 13-24: 1.0 mg/kg/week * Weeks 25-36: 2.0 mg/kg/week Subjects who complete the 36-week Dose-Escalation Period will hav...
intervention 1: BMN 110
3
Birmingham | N/A | United Kingdom | -1.89983 | 52.48142 London | N/A | United Kingdom | -0.12574 | 51.50853 Manchester | N/A | United Kingdom | -2.23743 | 53.48095
94
0
0
0
NCT00884949
1COMPLETED
2011-03-01
2009-04-01
BioMarin Pharmaceutical
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
108
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
1FEMALE
true
The purpose of this study is to see if inserting misoprostol in the vagina or between your cheek and gum before inserting an Intrauterine Device (IUD) in a woman who has never had a baby makes it easier and less painful.
Intrauterine Devices (IUDs) are an excellent method of contraception but are underutilized in the U.S. IUD use is expanding in the U.S. and is now routinely recommended for nulliparous women. The cervix of a nulliparous woman has a smaller diameter and can lead to more difficult and uncomfortable IUD insertions. Becaus...
Contraception
IUD insertion Nulliparous women Contraception Family Planning IUD insertion in nulliparous women
null
2
arm 1: Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire. arm 2: Pills which are identical to the study drug in appearance, taste, and smell.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 400 micrograms inserted vaginally or buccally, per the participants desire prior to the IUD insertion. intervention 2: Pills which are identical to the study drug in appearance, taste, and smell.
intervention 1: Misoprostol intervention 2: Placebo
2
Salt Lake City | Utah | United States | -111.89105 | 40.76078 Salt Lake City | Utah | United States | -111.89105 | 40.76078
105
0
0
0
NCT00886834
1COMPLETED
2011-03-01
2009-04-01
University of Utah
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 ]
886
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk mitigation strategies developed in partnership w...
null
Rheumatoid Arthritis
null
3
arm 1: Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase at the investigator's discretion. arm 2: Participants receiv...
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: 8 mg/kg intravenous every 4 weeks for 24 weeks intervention 2: 4 mg/kg every 4 weeks for 24 weeks intervention 3: Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
intervention 1: tocilizumab [RoActemra/Actemra] intervention 2: tocilizumab [RoActemra/Actemra] intervention 3: Nonbiologic DMARDs of investigator's choice
227
Anniston | Alabama | United States | -85.83163 | 33.65983 Birmingham | Alabama | United States | -86.80249 | 33.52066 Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Montgomery | Alabama | Unit...
883
0
0
0
NCT00891020
1COMPLETED
2011-03-01
2009-05-01
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 ]
75
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
null
The main purpose of this clinical trial with BI 207127 is to see the effect of 4 week combination of BI 207127 with Peginterferon alfa (Peg-IFN) and Ribavirin (RBV) on hepatitis C virus (HCV) virus load and how safe BI 207127 is in this combination in HCV infected patients.
null
Hepatitis C, Chronic
null
4
arm 1: BI 207127 low dose tid + SOC arm 2: BI 207127 middle dose tid + SOC arm 3: BI 207127 high dose tid +SOC arm 4: Placebo tid +SOC
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: BI 207127 middle dose tid + SOC intervention 2: BI 207127 high dose tid +SOC intervention 3: Placebo tid +SOC intervention 4: BI 207127 low dose tid + SOC
intervention 1: BI 207127 middle dose +SOC intervention 2: BI 207127 high dose+SOC intervention 3: Placebo + SOC intervention 4: BI 207127 low dose + SOC
18
Grenoble Cédex 9 | N/A | France | N/A | N/A Lille | N/A | France | 3.05858 | 50.63297 Lyon | N/A | France | 4.84671 | 45.74846 Montpellier | N/A | France | 3.87635 | 43.61093 Nice | N/A | France | 7.26608 | 43.70313 Pessac | N/A | France | -0.6324 | 44.80565 Vandœuvre-lès-Nancy | N/A | France | 6.17114 | 48.66115 Aache...
57
0
0
0
NCT00905632
1COMPLETED
2011-03-01
2009-05-01
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, 3 ]
10
RANDOMIZED
CROSSOVER
0TREATMENT
3TRIPLE
false
0ALL
false
The purpose of this study is to determine the effectiveness and safety of Interleukin-1-Receptor Antagonist eye drops for the treatment of corneal blood vessels.
Normally avascular, under many pathologic conditions, vessels may invade the cornea from the limbal vascular plexus. Infection, inflammation, ischemia, degeneration, or trauma, and the loss of the limbal stem cell barrier can cause corneal neovascularization. Growth of new vessels may result in corneal scarring, edema,...
Corneal Neovascularization
null
2
arm 1: It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra. arm 2: It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Custom eye drop eye three times a day in both eyes for a period of 6 weeks intervention 2: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
intervention 1: Placebo intervention 2: IL-1Ra
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
30
0
0
0
NCT00915590
6TERMINATED
2011-03-01
2009-04-01
Reza Dana, MD
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
12
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of this study is to evaluate pharmacokinetics (what body does to medication), safety, tolerability, and efficacy (effectiveness) of darunavir with low-dose ritonavir (DRV/rtv) administered once daily, in combination with an investigator-selected background regimen consisting of other antiretrovirals (ARVs) ...
This is an open-label (all people know the identity of the intervention), single-arm, Phase II study to evaluate the pharmacokinetics, safety, tolerability, and efficacy of darunavir/ritonavir (DRV/rtv) administered once daily, in combination an investigator-selected background regimen (2 NRTIs), in treatment-naive HIV...
HIV-1 Infection
HIV Infections TMC114-TiDP29-C230 TMC114-C230 TMC114 HIV-1 Darunavir Ritonavir NRTI Treatment Naive
null
1
arm 1: Patients will receive darunavir tablets 2 x 400 mg in combination with ritonavir capsule 100 mg once daily for 48 weeks along with 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) ie, either zidovudine/lamivudine or abacavir/lamivudine
[ 0 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Type=exact number, unit=mg, number=400, formulation=tablet, route=oral. 2 tablets of darunavir administered once daily for 48 weeks intervention 2: Type=exact number, unit=mg, number=100, formulation=capsule, route=oral. 1 capsule of ritonavir administered once daily for 48 weeks intervention 3: NRTI (z...
intervention 1: darunavir intervention 2: ritonavir intervention 3: zidovudine intervention 4: lamivudine intervention 5: abacavir
9
Memphis | Tennessee | United States | -90.04898 | 35.14953 Paris | N/A | France | 2.3488 | 48.85341 Dublin | N/A | Ireland | -6.24889 | 53.33306 Esplugues de Llobregat | N/A | Spain | 2.08809 | 41.37732 Madrid | N/A | Spain | -3.70256 | 40.4165 Kiev | N/A | Ukraine | 30.5238 | 50.45466 Birmingham | N/A | United Kingdom...
12
0
0
0
NCT00915655
1COMPLETED
2011-03-01
2009-07-01
Tibotec Pharmaceuticals, Ireland
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
41
RANDOMIZED
SINGLE_GROUP
null
1SINGLE
false
0ALL
false
This research is studying how Vitamin D may affect blood vessels reaction to stress and blood levels of substances that may increase blockages in the blood vessels in chronic kidney disease (CKD) patients. Blood vessel health is worsened in CKD and some studies have shown that Vitamin D improves blood vessel health. Th...
null
Chronic Kidney Disease
chronic kidney disease Vitamin D
null
2
arm 1: None arm 2: None
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: paricalcitol 1 mcg QD x 8 weeks intervention 2: Placebo for Paricalcitol 1 mcg QD x 8 weeks
intervention 1: Paricalcitol intervention 2: Placebo
1
Albany | New York | United States | -73.75623 | 42.65258
41
0
0
0
NCT00915876
1COMPLETED
2011-03-01
2009-03-01
Amy Barton Pai
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 ]
237
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.
null
Rheumatoid Arthritis
Rheumatoid Arthritis, RA, ACR, inflammatory joints
null
5
arm 1: Secukinumab 25mg s.c. q4wk arm 2: Secukinumab 75mg s.c. q4wk arm 3: Secukinumab 150mg s. c. q4wk arm 4: Secukinumab 300mg s.c. q4wk arm 5: Secukinumab Placebo s.c. q4wk
[ 0, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Secukinumab was supplied as a 150mg lyophiized cake in individual glass vials each. The study drug dose levels were 25mg, 75mg, 150mg and 300mg and was administered subcutaneously. intervention 2: Secukinumab placebo was supplied as a 150mg lyophiized cake in individual glass vials each. The placebo dos...
intervention 1: Secukinmab intervention 2: Placebo
58
Mesa | Arizona | United States | -111.82264 | 33.42227 Peoria | Arizona | United States | -112.23738 | 33.5806 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Santa Monica | California | United States | -118.49138 | 34.01949 Coeur d'Alene | Idaho | United States | -116.78047 | 47.67768 Springfield | Illin...
453
0
0
0
NCT00928512
1COMPLETED
2011-03-01
2009-07-01
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
[ 4 ]
859
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
2MALE
true
A phase 3, open-label, parallel group, one year trial comparing the efficacy and safety of degarelix 3-month depot with the established therapy goserelin acetate 3-month implant in patients with prostate cancer.
null
Prostate Cancer
null
2
arm 1: None arm 2: None
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations). in...
intervention 1: Degarelix intervention 2: Goserelin acetate
126
Homewood | Alabama | United States | -86.80082 | 33.47177 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 La Mesa | California | United States | -117.02308 | 32.76783 Laguna Hills | California | United States | -117.71283 | 33.61252 Long Beach | ...
848
0
0
0
NCT00946920
1COMPLETED
2011-03-01
2009-06-01
Ferring Pharmaceuticals
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
32
NON_RANDOMIZED
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This is a research study in 2 parts assessing the following parameters of the combination of the study drug called bosutinib, and a drug called capecitabine: the safety, how well the subject's body handles the study drug, and preliminary anti-tumor activity as treatment for different types of cancers in part 1, and bre...
The study was prematurely discontinued following Part 1 evaluation, when the sponsor concluded that further translational biomarker analyses were needed to better define the breast tumor biomarkers that predict sensitivity to Src family kinase inhibitors. Thus the Sponsor made a determination to stop the study after Pa...
Advanced Breast Cancer (Parts 1 and 2) Advanced Pancreatic Cancer (Part 1) Advanced Colorectal Cancer (Part 1) Advanced Cholangiocarcinoma (Part 1) Advanced Glioblastoma Multiforme (Part 1)
Phase 1/2 2-part study bosutinib and capecitabine
null
1
arm 1: In part 1 (phase 1), ascending and descending multiple oral doses of bosutinib + capecitabine. Doses in part 1 include capecitabine 750 mg/m2 BID on days 1-14 + bosutinib 200 mg QD; capecitabine 625 mg/m2 BID on days 1-14 + bosutinib 300 mg QD. Depending on safety, capecitabine can also be administered at 1000 m...
[ 0 ]
2
[ 0, 0 ]
intervention 1: Doses in part 1 include bosutinib 200 mg QD; bosutinib 300 mg QD. Depending on safety bosutinib can be administered at 200 mg/m2 QD. The MTD of the combination treatment determined from part 1, will be administered in part 2 (phase 2). intervention 2: Doses in part 1 include capecitabine 750 mg/m2 BID o...
intervention 1: Bosutinib intervention 2: Capecitabine
7
Boston | Massachusetts | United States | -71.05977 | 42.35843 Detroit | Michigan | United States | -83.04575 | 42.33143 Adelaide | South Australia | Australia | 138.59863 | -34.92866 Edegem | N/A | Belgium | 4.44504 | 51.15662 Saint-Herblain | N/A | France | -1.651 | 47.21154 Hong Kong | N/A | Hong Kong | 114.17469 | 2...
32
0
0
0
NCT00959946
6TERMINATED
2011-03-01
2009-09-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
399
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.
null
Arthritis, Rheumatoid
randomized double-blind placebo-controlled investigational drug oral therapy safety and efficacy
null
4
arm 1: None arm 2: None arm 3: None arm 4: None
[ 0, 0, 2, 2 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 2: Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period. intervention 3: Oral placebo tablets administered BID daily during th...
intervention 1: CP-690,550 intervention 2: CP-690,550 intervention 3: Placebo intervention 4: CP-690,550 intervention 5: Placebo intervention 6: CP-690,550
92
Birmingham | Alabama | United States | -86.80249 | 33.52066 Los Angeles | California | United States | -118.24368 | 34.05223 Los Angeles | California | United States | -118.24368 | 34.05223 San Diego | California | United States | -117.16472 | 32.71571 Farmington | Connecticut | United States | -72.83204 | 41.71982 Tru...
798
0
0
0
NCT00960440
1COMPLETED
2011-03-01
2009-10-01
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 ]
50
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This study is for patients with metastatic colorectal cancer who have not been treated with chemotherapy for their cancer. The purpose of this study is to find out if Capecitabine and Sunitinib can be used together to improve progression-free survival in colorectal cancer. All patients will take two medicines (Sunitin...
This is a single-center, open-label, one-arm study. Patients will be stratified by prior adjuvant therapy and ECOG performance status at study entry. In this study, we propose to obtain PET scans at baseline, 2 weeks, 8 weeks and 24 weeks from the initiation of treatment. Response at 2 weeks, 8 weeks and 24 weeks will...
Metastatic Colorectal Cancer
colorectal cancer sunitinib capecitabine
null
1
arm 1: Administration of sunitinib and capecitabine
[ 0 ]
1
[ 0 ]
intervention 1: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily
intervention 1: sunitinib and capecitabine
1
Washington D.C. | District of Columbia | United States | -77.03637 | 38.89511
11
0
0
0
NCT00961571
6TERMINATED
2011-03-01
2009-08-01
Georgetown 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 ]
33
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The primary objective of this trial is to assess the antitumor activity of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) in Japanese subjects.
null
Squamous Cell Carcinoma of the Head and Neck
Recurrent and/or metastatic SCCHN
null
1
arm 1: None
[ 0 ]
3
[ 0, 0, 0 ]
intervention 1: The initial dose of cetuximab will be 400 milligram per square meter (mg/m\^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m\^2 as an IV infusion over 60 minutes. intervention 2: Subjects will receive 100 mg/m\^2 cisplatin as an IV infusion over 60 minutes on...
intervention 1: Cetuximab intervention 2: Cisplatin/Carboplatin intervention 3: 5-Fluorouracil
10
Aichi | N/A | Japan | 130.62158 | 32.51879 Chiba | N/A | Japan | 140.11667 | 35.6 Ehime | N/A | Japan | N/A | N/A Hokkaido | N/A | Japan | N/A | N/A Kanagawa | N/A | Japan | 139.91667 | 37.58333 Kanagawa | N/A | Japan | 139.91667 | 37.58333 Osaka | N/A | Japan | 135.50107 | 34.69379 Shizuoka | N/A | Japan | 138.38333 |...
33
0
0
0
NCT00971932
1COMPLETED
2011-03-01
2009-07-01
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
[ 4 ]
194
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) in combination with Sulfonylurea in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with Sulfonylurea with an extension treatment for up to 52 weeks.
null
Type 2 Diabetes Mellitus
insulin resistance
null
2
arm 1: None arm 2: None
[ 2, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with sulfonylurea intervention 2: Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination wi...
intervention 1: Placebo / Teneli (Teneligliptin) + SU (Sulfonylurea) intervention 2: Teneli / Teneli + SU
1
Sapporo | Hokkaido | Japan | 141.35 | 43.06667
385
0
0
0
NCT00974090
1COMPLETED
2011-03-01
2009-09-01
Mitsubishi Tanabe Pharma Corporation
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
471
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
This is a study to evaluate the safety and efficacy of IPX066 in advanced Parkinson's disease.
A randomized, double-blind, active-control, parallel-group 13-week comparison of IPX066 versus regular carbidopa-levodopa (CD-LD). Prior to randomization, subjects on a stable regular LD regimen will enter a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.
Parkinson's Disease
Parkinson's Disease
null
2
arm 1: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066. arm 2: Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: extended-release carbidopa-levodopa capsules intervention 2: immediate-release carbidopa-levodopa tablets
intervention 1: IPX066 intervention 2: IR CD-LD
73
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Little Rock | Arkansas | United States | -92.28959 | 34.74648 La Jolla | California | United States | -117.2742 | 32.84727 Sunnyvale | California | United States | -122.03635 | 37.36883 Torrance | Calif...
393
0
0
0
NCT00974974
1COMPLETED
2011-03-01
2009-09-01
Impax Laboratories, 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 ]
319
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of this study is to evaluate benefits and risks of lixisenatide (AVE0010), in comparison to sitagliptin, as an add-on treatment to metformin, in obese (body mass index \[BMI\] greater than or equal to 30 kilogram per square meter \[kg/m\^2\]) type 2 diabetic patients less than 50 years of age, over a period...
null
Type 2 Diabetes Mellitus
null
2
arm 1: 2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24. arm 2: Sitagliptin al...
[ 0, 1 ]
6
[ 0, 0, 1, 0, 0, 0 ]
intervention 1: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 2: Self-administered by subcutaneous injections once daily within the hour preceding breakfast. intervention 3: None intervention 4: Administered orally once a day in the morning with or without foo...
intervention 1: Lixisenatide (AVE0010) intervention 2: Lixisenatide Placebo intervention 3: Pen auto-injector intervention 4: Sitagliptin intervention 5: Sitagliptin Placebo intervention 6: Metformin
92
Montgomery | Alabama | United States | -86.29997 | 32.36681 Muscle Shoals | Alabama | United States | -87.66753 | 34.74481 Mesa | Arizona | United States | -111.82264 | 33.42227 Anaheim | California | United States | -117.9145 | 33.83529 Paramount | California | United States | -118.15979 | 33.88946 Redlands | Californ...
319
0
0
0
NCT00976937
1COMPLETED
2011-03-01
2009-08-01
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
[ 4 ]
723
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
A multi-center, randomized, double-blind, placebo-controlled, 4-arm clinical study to evaluate efficacy and safety of nicotine lozenge (2mg and 4mg) in smoking cessation in adult cigarette smokers who are motivated to quit smoking. Successful quitters or participants who smoke occasionally will be followed up after wee...
null
Smoking
smoking cessation nicotine lozenge nicotine replacement therapy
null
4
arm 1: 2 mg nicotine lozenge arm 2: 2 mg placebo arm 3: 4 mg nicotine lozenge arm 4: 4 mg placebo
[ 0, 2, 0, 2 ]
2
[ 0, 0 ]
intervention 1: 2 mg or 4 mg nicotine lozenge intervention 2: placebo lozenge
intervention 1: Nicotine intervention 2: Placebo
0
null
720
0
0
0
NCT00985985
1COMPLETED
2011-03-01
2009-05-01
GlaxoSmithKline
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 0 ]
50
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
Women who are requesting pregnancy termination at 14-16 weeks, who would normally have osmotic dilator insertion the day before their procedure, would be asked if they wanted to participate. Participants would be randomized to two groups: first, dilator insertion as usual, or second, mifepristone taken the day before t...
null
Abortion
Length of time for procedure to be completed Need for additional dilation Subject satisfaction with procedure
null
2
arm 1: women in the mifepristone are would take mifepristone 200 mg for cervical preparation the day before their procedure, and not have dilators inserted. In this group, the sstandard procedure of osmotic dilator insertion is NOT performed. arm 2: Women assigned to this arm would have the standard procedure for cervi...
[ 0, 1 ]
2
[ 0, 1 ]
intervention 1: mifepristone would be given the day before the procedure intervention 2: osmotic dilators (3-6) would be inserted as usual the day before the procedure
intervention 1: mifepristone 200 mg intervention 2: osmotic dilator insertion
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
50
0
0
0
NCT00986921
1COMPLETED
2011-03-01
2009-10-01
Boston University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
36
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The major purpose of this exploratory developmental study will be to develop a patient-centered and feasible protocol for communicating genetic data as it relates to drug efficacy for smoking cessation inpatients receiving medication that is matched to individual genotypes associated with increased efficacy for bupropi...
Therefore, our specific aims are to: Aim 1: Conduct formative research to develop and refine a clinical protocol for a multi-component smoking cessation intervention, grounded in the extended parallel process model, consisting of pharmacogenetic treatment (smoking cessation drug matched to each individual smoker's gen...
Smoking
pharmacogenetics genetic counseling genetic feedback nicotine replacement bupropion smoking cessation primary care telehealth motivational interviewing
null
2
arm 1: * Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling. * A self-help guide for smoking cessation (Clearing the Air, NCI)sent by mail * A standard 8-week course of genetically-tailored pharmacotherapy * Particip...
[ 1, 0 ]
5
[ 5, 5, 0, 5, 5 ]
intervention 1: Three 20-minute telephone calls during which a certified tobacco treatment specialist delivered motivationally-enhanced cognitive behavioral counseling 1. One week prior to the target quit date (TQD) 2. Two weeks post-TQD 3. Four weeks post-TQD intervention 2: A printed self-help guide for smoking cess...
intervention 1: Counseling intervention 2: Self-help guide intervention 3: Pharmacotherapy intervention 4: Genetic feedback, verbal intervention 5: Genetic feedback, printed
3
Menlo Park | California | United States | -122.18219 | 37.45383 Stanford | California | United States | -122.16608 | 37.42411 Seattle | Washington | United States | -122.33207 | 47.60621
36
0
0
0
NCT00991081
1COMPLETED
2011-03-01
2009-07-01
Stanford 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 ]
125
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
false
The primary study objective was to compare the rate of "all hypoglycemia" (composite outcome of the following hypoglycemia events: symptomatic hypoglycemia episodes, low continuous glucose monitoring system (CGMS) excursions confirmed by fingerstick blood glucose (FSBG), low FSBG readings performed at other times) betw...
Screening phase: 2 to 4 weeks Treatment phase: 24 weeks At randomization, patients were stratified with respect to their baseline HbA1c level (\<8.5% or ≥8.5%) and hypoglycemic event rate (number of CGMS hypoglycemic excursions \<0.5 or ≥0.5 events per 24 hours). Following randomization, trial basal insulin was initi...
Type 1 Diabetes Mellitus
null
2
arm 1: Lantus given as basal insulin once a day in the morning by subcutaneous injection arm 2: Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day generally in the morning and /or at bedtime by subcutaneous injection
[ 0, 1 ]
3
[ 0, 0, 0 ]
intervention 1: 100 U/mL commercial solution for injection available as both disposable pen devices Solostar® each containing 300 U and as 10 mL vials each containing 1000 U Dose: titrated to achieve the following glycemic targets without hypoglycemia: * Fasting blood glucose (BG) between 90 and 145 mg/dL (5.0 to 8.0...
intervention 1: Insulin glargine (HOE901) intervention 2: Neutral Protamine Hagedorn (NPH) insulin intervention 3: Insulin lispro
61
Sacramento | California | United States | -121.4944 | 38.58157 San Diego | California | United States | -117.16472 | 32.71571 Greenwood Village | Colorado | United States | -104.95081 | 39.61721 Baltimore | Maryland | United States | -76.61219 | 39.29038 Buffalo | New York | United States | -78.87837 | 42.88645 Philade...
125
0
0
0
NCT00993473
1COMPLETED
2011-03-01
2009-10-01
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
[ 3 ]
679
RANDOMIZED
PARALLEL
9OTHER
2DOUBLE
false
0ALL
true
This study will investigate the safety of three fixed dose levels of tanezumab (2.5 mg, 5 mg, and 10 mg) administered at an 8-week interval by subcutaneous injection multiple (7) times during the study treatment period.
Safety study of tanezumab in relief of osteoarthritis pain This study was terminated on 6 December 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, Knee Osteoarthritis, Hip
Double-blind safety
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 2: Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for a total of 7 injections administered over approximately 1 year intervention 3: ...
intervention 1: Tanezumab 2.5 mg intervention 2: Tanezumab 5 mg intervention 3: Tanezumab 10 mg
100
Mobile | Alabama | United States | -88.04305 | 30.69436 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United St...
678
0
0
0
NCT00994890
6TERMINATED
2011-03-01
2009-11-17
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
949
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
1FEMALE
true
The objective of this trial is to assess the safety and efficacy of 24-week course of flibanserin for the treatment of Hypoactive Sexual Desire Disorder (HSDD) in naturally postmenopausal women.
null
Sexual Dysfunctions, Psychological
null
2
arm 1: flibanserin 100mg po qd arm 2: placebo one tablet po qd
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: patients will be randomized to flibanserin or placebo in a double-blind manner intervention 2: patients will be randomized to flibanserin or placebo in a double-blind manner
intervention 1: flibanserin intervention 2: placebo
75
Birmingham | Alabama | United States | -86.80249 | 33.52066 Huntsville | Alabama | United States | -86.58594 | 34.7304 Mobile | Alabama | United States | -88.04305 | 30.69436 Phoenix | Arizona | United States | -112.07404 | 33.44838 Phoenix | Arizona | United States | -112.07404 | 33.44838 Encinitas | California | Unit...
949
0
0
0
NCT00996372
1COMPLETED
2011-03-01
2009-10-01
Sprout 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
[ 4 ]
39
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether low dose Asacol® (27 mg/kg - 71 mg/kg) and high dose Asacol® (53 mg/kg - 118 mg/kg) are safe and effective when dosed as 400 mg delayed-release tablets given twice daily for 26 weeks to children and adolescents for the maintenance of remission of ulcerative colitis.
null
Ulcerative Colitis
null
2
arm 1: 2.0 - 4.8 g/day Asacol dependent on body weight arm 2: 1.2 - 2.4 g/day Asacol dependent upon body weight
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: 17-33kg = 3 Asacol 400mg AM \& 2 Asacol 400mg PM; 33-\<54kg = 5 Asacol 400 mg AM \& 4 Asacol 400mg PM; 54-\<90kg = 6 Asacol 400mg AM \& PM intervention 2: 17-\<33kg = 2 Asacol 400mg \& 1 placebo AM, 1 Asacol 400mg \& 1 placebo PM; 33-\<54kg = 3 Asacol 400mg \& 2 placebo AM, 2 Asacol 400mg \& 2 placebo P...
intervention 1: Asacol 400 mg intervention 2: Asacol 400 mg
51
Birmingham | Alabama | United States | -86.80249 | 33.52066 Phoenix | Arizona | United States | -112.07404 | 33.44838 Loma Linda | California | United States | -117.26115 | 34.04835 San Diego | California | United States | -117.16472 | 32.71571 San Francisco | California | United States | -122.41942 | 37.77493 San Fran...
39
0
0
0
NCT01004185
6TERMINATED
2011-03-01
2009-10-01
Warner Chilcott
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
36
RANDOMIZED
CROSSOVER
1PREVENTION
0NONE
false
0ALL
null
This study evaluates the effect on LDL cholesterol of the 3 drugs given together in the cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin, and ramipril) as compared to the effect on LDL cholesterol of simvastatin given alone. Approximately 76 subjects will be screened, 60 randomized in order...
null
Elevated LDL Cholesterol
cardiovascular fixed dose combination pill LDL cholesterol
null
2
arm 1: Once daily oral dose of combination of acetylsalicylic acid, simvastatin, and ramipril (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 or 10 mg ramipril) arm 2: Once daily oral dose of Simvastatin 40 mg
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 12 weeks. intervention 2: A once daily oral dose of simvastatin for 12 weeks.
intervention 1: Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril), intervention 2: Simvastatin
1
New York | New York | United States | -74.00597 | 40.71427
106
0
0
0
NCT01004705
6TERMINATED
2011-03-01
2009-09-01
Ferrer Internacional 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 ]
336
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
true
The primary purpose of this study was to see how tasisulam-sodium affected metastatic melanoma when compared against paclitaxel as measured by overall survival.
null
Melanoma
metastatic second-line
null
2
arm 1: Individualized tasisulam-sodium dose was dependent on participant's height, weight, and gender. Dose was adjusted based on laboratory parameters. Treatment was administered intravenously on Day 1 of a 28-day cycle, until disease progression. arm 2: Paclitaxel 80 milligrams per square meter (mg/m\^2) administered...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Administered intravenously on Day 1 of a 28-day cycle, until disease progression. intervention 2: 80 mg/m\^2 administered intravenously on Days 1, 8, and 15 of a 28-day cycle, until disease progression
intervention 1: Tasisulam-sodium intervention 2: Paclitaxel
122
Birmingham | Alabama | United States | -86.80249 | 33.52066 Scottsdale | Arizona | United States | -111.89903 | 33.50921 Tucson | Arizona | United States | -110.92648 | 32.22174 Little Rock | Arkansas | United States | -92.28959 | 34.74648 Fresno | California | United States | -119.77237 | 36.74773 Los Angeles | Califo...
325
0
0
0
NCT01006252
6TERMINATED
2011-03-01
2009-12-01
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
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
9
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
1.Phase I: To estimate the Maximum Tolerated Dose (MTD) of RAD001 in combination with cetuximab and cisplatin for treatment of metastatic squamous cell cancer of the head and neck (SCCHN). Secondary Objectives 1.To assess the toxicity of RAD001 in combination with weekly cetuximab and cisplatin on days 1 and 8 of eac...
This was a dose escalation study with RAD001 in combination with cetuximab and cisplatin in recurrent/metastatic SCCHN. Patients with ECOG performance status 0-2, with no prior systemic therapy for recurrent/metastatic SCCHN were enrolled. The dose levels for RAD001 were 2.5mg, 5mg or 10 mg administered oral daily, cet...
Head and Neck Cancer
null
1
arm 1: Daily RAD001 in combination with weekly cetuximab and cisplatin/ carboplatin on Day 1, 8 of each 28 day cycle.
[ 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Dose Level -1 2.5mg/day Dose Level 1 5mg/day\* Dose Level 2 10mg/day MTD RAD001 intervention 2: 250mg/m2/week intervention 3: 40mg/m2 Day 1, 8 every 28 days intervention 4: Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will b...
intervention 1: RAD001 intervention 2: Cetuximab intervention 3: Cisplatin intervention 4: Carboplatin
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
9
0
0
0
NCT01009346
6TERMINATED
2011-03-01
2009-10-01
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2, 3 ]
16
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The purpose of this study is to determine the appropriate dose and effectiveness of intra-nasal administration of a potent narcotic, sufentanil, for the treatment of moderate to severe pain due to broken bone(s) in the arm or leg.
null
Pain Opiate
acute pain, intranasal, sufentanil, Acute pain control with an intranasal opiate
null
1
arm 1: Intranasal sufentanil administered at a dose of 0.5 mcg/kg times one dose at beginning of thirty minute period
[ 0 ]
1
[ 0 ]
intervention 1: Intra-nasal delivery, dosing range 0.5 mcg/kg, administered once at the beginning of the 30 minute study period
intervention 1: sufentanil
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
16
0
0
0
NCT01012999
6TERMINATED
2011-03-01
2009-11-01
University of Utah
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 ]
1,334
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
2MALE
false
Clinical study to examine the efficacy, safety and tolerability of combination therapy of tamsulosin hydrochloride and solifenacin succinate compared to monotherapy of tamsulosin hydrochloride in the treatment of males with LUTS associated with BPH with a substantial storage component.
null
Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms
EC905 Solifenacin succinate Tamsulosin hydrochloride OCAS Treatment Benign Prostatic Hyperplasia Vesomni Lower Urinary Tract Symptoms
null
4
arm 1: Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 ...
[ 2, 1, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: tablet intervention 2: tablet intervention 3: tablet intervention 4: tablet intervention 5: tablet intervention 6: tablet
intervention 1: Placebo tamsulosin hydrochloride OCAS 0.4 mg intervention 2: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg intervention 3: Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg intervention 4: tamsulosin hydrochloride OCAS 0.4 mg intervention 5: tamsulosin hydro...
118
Innsbruck | N/A | Austria | 11.39454 | 47.26266 Salzburg | N/A | Austria | 13.04399 | 47.79941 Vienna | N/A | Austria | 16.37208 | 48.20849 Minsk | N/A | Belarus | 27.56653 | 53.90019 Minsk | N/A | Belarus | 27.56653 | 53.90019 Minsk | N/A | Belarus | 27.56653 | 53.90019 Antwerp | N/A | Belgium | 4.40026 | 51.22047 Ant...
1,328
0
0
0
NCT01018511
1COMPLETED
2011-03-01
2010-01-11
Astellas Pharma Europe B.V.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
20
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
This phase I single center open labeled study is planned to assess the safety and tolerability of bevacizumab for treating patients with bilateral Recurrent Respiratory Papillomatosis (RRP). Approximately 20 patients will receive bevacizumab directly injected into the vocal folds. Patients who enroll in the protocol wi...
null
Recurrent Respiratory Papillomatosis
null
0
null
null
2
[ 0, 0 ]
intervention 1: Bevacizumab injections (\~7.5-12.5mg in 0.3 - 0.5 c.c.) into diseased vocal folds in conjunction with 532 nm pulsed-KTP laser photoangiolysis, administered every 6 ±1 weeks, for a total of 5 treatments. No patient will have an injection volume exceed 0.5 cc. for any single treatment. If initial results ...
intervention 1: Avastin® (bevacizumab) intervention 2: Saline
1
Boston | Massachusetts | United States | -71.05977 | 42.35843
20
0
0
0
NCT01020747
1COMPLETED
2011-03-01
2009-11-01
Massachusetts General Hospital
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
9
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
true
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated...
null
Mantle Cell Lymphoma Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma Non-Hodgkin's Lymphoma CC-5013 Revlimid Lenalidomide
null
2
arm 1: Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. arm 2: Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or unti...
[ 0, 0 ]
2
[ 0, 10 ]
intervention 1: 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal. intervention 2: Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or u...
intervention 1: Lenalidomide intervention 2: Placebo
92
San Diego | California | United States | -117.16472 | 32.71571 Denver | Colorado | United States | -104.9847 | 39.73915 Chicago | Illinois | United States | -87.65005 | 41.85003 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Lincoln | Nebraska...
9
0
0
0
NCT01021423
6TERMINATED
2011-03-01
2010-04-01
Celgene
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
24
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
true
0ALL
false
Fibrates reduce atherosclerosis and cardiovascular disease events. A major mechanism of this benefit appears to be their ability to raise plasma high density lipoprotein cholesterol (HDL-C), especially in patients with high triglyceride levels. This study will investigate the effects of the addition of Trilipix (fenofi...
The field of lipid treatment for atheroprevention, and of HDL-raising in particular, was shaken by the unexpected finding of a net adverse clinical effect of torcetrapib, a Cholesteryl ester transfer protein (CETP) inhibitor with HDL-raising effects far more dramatic than that of niacin or fenofibrate. Trilipix (ABT 3...
Dyslipidemia
high density lipoprotein arterial compliance brachial artery flow-mediated dilatation
null
2
arm 1: Trilipix (fenofibric acid) 135 mg tablet orally, once daily for 12 weeks arm 2: Matching placebo tablet orally, once daily for 12 weeks
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: 135 mg po daily intervention 2: one tablet po daily
intervention 1: Trilipix intervention 2: placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
24
0
0
0
NCT01025492
6TERMINATED
2011-03-01
2009-11-01
University of Utah
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 ]
17
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
true
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, improves social cognition, social functioning and decreases paranoia and other psychotic symptoms in schizophrenia. Participants: Up to 80 adults with schizophrenia for at least one year and with a high rating for paranoia. Procedures (met...
Inclusion criteria: meeting Diagnostic and Statistical Manual IV (DSM-IV) criteria for paranoid or undifferentiated schizophrenia for at least 1 year; scoring \> 4 on the suspiciousness/persecution (hereafter referred to as paranoia) subscale of the Positive and Negative Symptom Scale (PANSS) or 3 on the paranoia subsc...
Paranoia Schizophrenia Schizoaffective Disorder
oxytocin social cognition social skill social functioning paranoia psychotic symptoms schizophrenia social deficits intranasal administration
null
2
arm 1: Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks arm 2: Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks intervention 2: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks
intervention 1: intranasal spray with oxytocin intervention 2: nasal spray without oxytocin
1
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132
17
0
0
0
NCT01028677
1COMPLETED
2011-03-01
2009-11-01
University of North Carolina, Chapel Hill
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
4QUADRUPLE
false
0ALL
false
The purpose of this study is to evaluate the efficacy, safety, and tolerability of orally administered tapentadol extended release (ER) at dosages of 100 to 250 mg twice daily compared with placebo in patients with moderate to severe pain due to chronic, painful diabetic peripheral neuropathy (DPN) who tolerated tapent...
This is a randomized-withdrawal (only patients that have an initial response to tapentadol are assigned to either tapentadol or placebo), placebo-controlled, multicenter study evaluating the efficacy, safety, and tolerability of orally administered tapentadol, using the extended release tamper-resistant formulation (TR...
Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy Painful Polyneuropathy Peripheral neuropathy
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Type= range, unit= mg, number= 100 to 250, form= tablet, route= oral use. Tapentadol ER optimal dose ranging between 100 mg and 250 mg twice daily for 15 weeks. intervention 2: Form= tablet, route= oral use. Matching placebo twice daily.
intervention 1: Tapentadol extended release (ER) intervention 2: Placebo
72
Mobile | Alabama | United States | -88.04305 | 30.69436 Chandler | Arizona | United States | -111.84125 | 33.30616 Mesa | Arizona | United States | -111.82264 | 33.42227 Phoenix | Arizona | United States | -112.07404 | 33.44838 Fresno | California | United States | -119.77237 | 36.74773 Orange | California | United Sta...
777
0
0
0
NCT01041859
1COMPLETED
2011-03-01
2009-12-01
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
156
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
false
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes
null
HSV-2
null
5
arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Oral administration intervention 2: Oral administration intervention 3: Oral administration intervention 4: Oral administration intervention 5: Oral administration
intervention 1: AIC316 intervention 2: AIC316 intervention 3: AIC316 intervention 4: AIC316 intervention 5: Placebo
6
Miami | Florida | United States | -80.19366 | 25.77427 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Portland | Oregon | United States | -122.67621 | 45.52345 Houston | Texas | United States | -95.36327 | 29.76328 Salt Lake City | Utah | United States | -111.89105 | 40.76078 Seattle | Washington | Unite...
155
0
0
0
NCT01047540
1COMPLETED
2011-03-01
2010-03-01
AiCuris Anti-infective Cures AG
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
198
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
Per randomization to the treatments and under double-blind conditions, patients were instructed to suck 1 sugar-based, flavoured flurbiprofen 8.75 mg lozenge or 1 sugar-based, flavoured matching vehicle control/placebo lozenge and remained at the study center for a 2-hour observation period to assess their responses to...
Pharyngitis
pharyngitis swollen throat difficulty swallowing
null
2
arm 1: Participants were instructed to suck one study (flurbiprofen 8.75 mg) lozenge and efficacy assessments were taken in the clinic. Upon discharge, participants were instructed to use another study medication lozenge every 3-6 hours, up to a total of 5 study lozenges in 24 hours. Following efficacy assessments, par...
[ 0, 2 ]
3
[ 0, 0, 0 ]
intervention 1: Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the...
intervention 1: placebo intervention 2: flurbiprofen intervention 3: acetaminophen 650mg
1
New York | New York | United States | -74.00597 | 40.71427
198
0
0
0
NCT01048866
1COMPLETED
2011-03-01
2009-11-01
Reckitt Benckiser 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 ]
204
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.
null
Pharyngitis
null
2
arm 1: Participants sucked flurbiprofen 8.75mg lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days. arm 2: Participants sucked vehicle placebo lozenge every 3-6 hours up to 5 lozenges a day as needed for pain for 7 days.
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours. intervention 2: Participants were instructed ...
intervention 1: Placebo intervention 2: Flurbiprofen
1
Storrs | Connecticut | United States | -72.24952 | 41.80843
204
0
0
0
NCT01049334
1COMPLETED
2011-03-01
2009-11-01
Reckitt Benckiser LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
CROSSOVER
0TREATMENT
2DOUBLE
false
0ALL
false
This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.
null
Asthma
null
4
arm 1: Placebo arm 2: Montelukast arm 3: Nedocromil arm 4: Mometasone
[ 0, 0, 0, 0 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge intervention 2: Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge intervention 3: Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge intervention 4: Mometaso...
intervention 1: Nedocromil intervention 2: Comparator: Montelukast intervention 3: Comparator: Mometasone intervention 4: Placebo
0
null
62
0
0
0
NCT01061333
1COMPLETED
2011-03-01
2010-06-01
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 ]
85
RANDOMIZED
PARALLEL
1PREVENTION
4QUADRUPLE
false
0ALL
true
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol (propofol and ketamine admixture with that of propofol alone (prototypic anesthesia induction agent). Propofol and ketamine are widely used as induction agents and their effects on patient...
This is a pilot study to compare the hemodynamic changes that occur during induction with a novel drug combination known as ketofol with that of propofol. Propofol and ketamine are widely used as induction agents and their effects on patient hemodynamics are well known. Many of these drug-induced changes are undesirabl...
Blood Pressure
ketofol hemodynamics propofol anesthesia
null
2
arm 1: As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. arm 2: As part of th...
[ 1, 0 ]
2
[ 0, 0 ]
intervention 1: As part of the induction, subjects will be given 2 milligrams per kilogram of body weight (mg/kg) of propofol. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL. The clinici...
intervention 1: Propofol intervention 2: Ketamine
1
Lebanon | New Hampshire | United States | -72.25176 | 43.64229
85
0
0
0
NCT01065350
1COMPLETED
2011-03-01
2010-12-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
1,293
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The primary purpose of the study is to investigate if Symbicort is more effective than Oxis in increasing forced expiratory volume in one second (FEV1), measured at the clinics, in patients with COPD.
null
Chronic Obstructive Pulmonary Disease
Symbicort Oxis Chronic Obstructive Pulmonary Disease COPD Efficacy
null
2
arm 1: Symbicort Turbuhaler 160/4.5 microgram, 2 inhalations twice daily arm 2: Oxis Turbuhaler 4.5 microgram, 2 inhalations twice daily
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: 2x160/4.5 microgram, inhalation, twice daily, 12 weeks intervention 2: 2 X 4.5 microgram, inhalation, twice daily, 12 weeks
intervention 1: Budesonide/formoterol (Symbicort Turbuhaler) intervention 2: Formoterol (Oxis Turbuhaler)
119
Bangalore | Karnataka | India | 77.59369 | 12.97194 Mysore | Karnataka | India | 76.63925 | 12.29791 Trivandrum | Kerala | India | 76.94924 | 8.4855 Indore | Madhya Pradesh | India | 75.8333 | 22.71792 Nagpur | Maharashtra | India | 79.08491 | 21.14631 New Delhi | National Capital Territory of Delhi | India | 77.2148 |...
1,293
0
0
0
NCT01069289
1COMPLETED
2011-03-01
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
[ 5 ]
527
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.
null
Major Depressive Disorder
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase. intervention 2: Participants received placebo QD, po for 8 weeks, followed by pl...
intervention 1: Duloxetine intervention 2: Placebo
34
Sherman Oaks | California | United States | -118.44925 | 34.15112 Cromwell | Connecticut | United States | -72.64537 | 41.5951 Fort Lauderdale | Florida | United States | -80.14338 | 26.12231 Orlando | Florida | United States | -81.37924 | 28.53834 Atlanta | Georgia | United States | -84.38798 | 33.749 Hoffman Estates ...
527
0
0
0
NCT01070329
1COMPLETED
2011-03-01
2010-03-01
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 ]
26
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
Over the past decade, the Rochester Center for Behavioral Medicine (RCBM) has evaluated many patients with attention deficit hyperactivity disorder (ADHD). A recurrent finding in these patients is a history of unexplained fatigue and musculoskeletal pain. Treatment of these patients in our clinic has revealed that whe...
As a result of these findings RCBM developed a chronic fatigue/fibromyalgia clinic in the early 2000's. This clinic was staffed by a board-certified rheumatologist and the psychiatric staff at RCBM. Through the major referral hospital in the area, patients with self-identified fibromyalgia and chronic fatigue were refe...
Chronic Fatigue Syndrome Cognitive Impairments
Chronic Fatigue Syndrome
null
2
arm 1: Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 vis...
[ 1, 2 ]
2
[ 0, 0 ]
intervention 1: Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or compar...
intervention 1: Lisdexamfetamine Dimesylate intervention 2: Placebo "30, 50 or 70 mg"
1
Rochester Hills | Michigan | United States | -83.14993 | 42.65837
26
0
0
0
NCT01071044
1COMPLETED
2011-03-01
2009-11-01
Rochester Center for Behavioral 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 ]
310
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
1FEMALE
false
This is an open-label, prospective, randomized, controlled, multicentric, multinational, phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with chronic anovulation. It has been observed that conventional high dose set up regimen of gonadotropin and human chorionic gonadotropin (hCG)...
Gonal-f is a recombinant form of human FSH (r-hFSH), an endogenous gonadotropin which is being produced in genetically engineered chinese hamster ovary cells and is indicated for induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ova...
Ovulation Induction
Infertility Ovulation induction Gonal-f Follitropin alpha Polycystic ovarian syndrome Anovulatory infertility
null
2
arm 1: Gonal-f will be injected on the second or third day of a spontaneous or progestogen-induced menstrual cycle (Day 0), with a daily dose of 75 International Units (IU) for 7 days. Ovarian response will be assessed on Day 7 of stimulation by ultrasound scan. If no follicle has reached at least 10 to 12 millimeter (...
[ 0, 0 ]
1
[ 0 ]
intervention 1: A starting dose of 75 IU and a first adjustment on Day 14 or Day 7 of stimulation in Group I and II respectively, if no ovarian response is observed.
intervention 1: Recombinant FSH (follitropin alpha)
3
As Sālimīyah | P.O.Box 6661 | Kuwait | 48.07611 | 29.33389 Hazmiyeh | P.O.Box 470 | Lebanon | 35.53589 | 33.85534 Jeddah | P.O.Box 80215 | Saudi Arabia | 39.18624 | 21.49012
310
0
0
0
NCT01081626
1COMPLETED
2011-03-01
2009-03-01
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
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
The purpose of the study is to find out the effects and the safety of an investigational study drug called LBH589 when given to people with relapsed or refractory chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL).
Response Assessment for Mantle Cell Lymphoma Based on the International Workshop to Standardize Response Criteria to non-hodgkin's lymphoma (NHL) (Cheson, JCO 1999) a complete hematologic remission will be defined as the following: * Disappearance of all evidence of disease. * Any positron emission tomography (PET)+ ...
Non-Hodgkin's Lymphoma
relapsed refractory CLL chronic lymphocytic leukemia MCL mantle cell lymphoma
null
1
arm 1: LBH589 will be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 \& 5, then 8, 10 \&12, then 15, 17 \& 19, then 22, 24 \& 26.
[ 0 ]
1
[ 0 ]
intervention 1: The LBH589 capsule(s) should be swallowed by mouth with a glass of water (8 ounces noncarbonated) in the morning. The daily dose of LBH589 should be taken at approximately the same time each day. Patients should avoid eating grapefruit, Seville (sour) orange or drinking grapefruit juice or Seville orang...
intervention 1: LBH589
1
Tampa | Florida | United States | -82.45843 | 27.94752
1
0
0
0
NCT01090973
6TERMINATED
2011-03-01
2010-03-01
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
[ 3 ]
423
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this study is to determine whether intra-articular (knee joint) administration of MEN16132 is effective reducing the pain from knee osteoarthritis.
MEN16132 is a non-peptide bradykinin B2-receptor antagonist showing analgesic and anti-inflammatory activity in nonclinical osteoarthritis models. This study is being conducted as a dose finding study to determine the safety and efficacy of MEN16132, given as three doses/four treatment regimens in comparison to placebo...
Osteoarthritis, Knee
Injections, Intra-Articular
null
5
arm 1: Intra-articular administration of two 0.125 mg doses of MEN16132 at 2-week interval. arm 2: Intra-articular administration of two 0.25 mg doses of MEN16132 at 2-week interval. arm 3: Intra-articular administration of two 0.5 mg doses of MEN16132 at 2-week interval. arm 4: Intra-articular administration of one 0....
[ 0, 0, 0, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: Intra-articular administration of two low doses of MEN16132 at 2-week interval. intervention 2: Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval intervention 3: Intra-articular injection of two high doses of MEN16132 at 2-week interval intervention 4: Single intra-artic...
intervention 1: MEN16132 - 0.125 mg intervention 2: MEN16132 - 0.25 mg intervention 3: MEN16132 - 0.5 mg intervention 4: MEN16132 - 0.5 mg intervention 5: Placebo
23
Orléans | N/A | France | 1.90389 | 47.90289 Paris | N/A | France | 2.3488 | 48.85341 Toulouse | N/A | France | 1.44367 | 43.60426 Bad Doberan | N/A | Germany | 11.90051 | 54.10712 Berlin | N/A | Germany | 13.41053 | 52.52437 Berlin | N/A | Germany | 13.41053 | 52.52437 Bochum | N/A | Germany | 7.21648 | 51.48165 Dresde...
421
0
0
0
NCT01091116
1COMPLETED
2011-03-01
2010-03-01
Menarini Group
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
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 ]
14
RANDOMIZED
CROSSOVER
null
3TRIPLE
false
0ALL
false
This study will evaluate whether crushed EMBEDA capsules induce clinical opiate withdrawal signs and symptoms in opioid-dependent patients with chronic non-cancer pain who are stabilized on EMBEDA.
The decision to terminate the trial was due to a lack of study drug supply. Decision was not based on any safety concerns. The date of the notification of termination letter was March 11, 2011.
Chronic Pain
opioid morphine naltrexone withdrawal signs withdrawal symptoms
null
2
arm 1: EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules crushed and mixed in solution and administered orally at each patient's stable dose, given either once daily or twice daily. arm 2: EMBEDA (morphine sulfate plus naltrexone hydrochloride ER) capsules, administered orally and intact at each patie...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily intervention 2: EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL p...
intervention 1: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush intervention 2: EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
34
0
0
0
NCT01100437
6TERMINATED
2011-03-01
2010-04-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
1
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
A phase 2 study combining pertuzumab with erlotinib for patients with gemcitabine refractory pancreatic adenocarcinoma
A single-institution, single-arm phase 2 study investigating pertuzumab and erlotinib as a palliative regimen in the treatment of locally-advanced or metastatic pancreatic adenocarcinoma.
Pancreatic Cancer
null
1
arm 1: Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks Erlotinib hydrochloride 150 mg/day by mouth
[ 0 ]
2
[ 0, 0 ]
intervention 1: iv, 840 mg, 420 mg intervention 2: PO, 150 mg
intervention 1: Pertuzumab intervention 2: Erlotinib
1
Stanford | California | United States | -122.16608 | 37.42411
1
0
0
0
NCT01108458
6TERMINATED
2011-03-01
2010-07-01
George Albert Fisher
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 ]
146
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
true
The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.
null
Stable Coronary Artery Disease
Stable Coronary Artery Disease Platelet Aggregation
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 1 ]
2
[ 0, 0 ]
intervention 1: Drug oral treatment intervention 2: Drug oral treatment
intervention 1: ticagrelor intervention 2: clopidogrel
13
Miyaodai | Fukuoka | Japan | 130.71276 | 33.84661 Sapporo | Hokkaido | Japan | 141.35 | 43.06667 Toride-shi | Ibaraki | Japan | N/A | N/A Kawasaki-shi | Kanagawa | Japan | N/A | N/A Kyoto | Kyoto | Japan | 135.75385 | 35.02107 Ōita | Oita Prefecture | Japan | 131.6 | 33.23333 Naha | Okinawa | Japan | 127.67851 | 26.213...
139
0
0
0
NCT01118325
1COMPLETED
2011-03-01
2010-04-01
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 ]
32
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The primary objective of this study is to evaluate the broad clinical benefit of dosing Seroquel XR with flexible in the treatment of acute bipolar mania patients with partial response to existing therapy. Clinical benefit will be assessed with the Clinical Global Impression-Clinical Benefit (CGI-CB) score, according t...
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial Response to Current Therapy
Acute Bipolar Mania
Acute bipolar mania Seroquel XR Quetiapine fumarate Add-on therapy
null
1
arm 1: Quetiapine fumarate (Seroquel XR)
[ 0 ]
1
[ 0 ]
intervention 1: Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.
intervention 1: Quetiapine fumarate (Seroquel XR)
11
Junam | Choongnam | South Korea | 129.15398 | 35.42306 Cheonan | Chungcheongnam-do | South Korea | 127.1522 | 36.8065 Chuncheon | Gangwondo | South Korea | 127.73417 | 37.87472 Bucheon-si | Gueonggido | South Korea | 126.78306 | 37.49889 Suwon | Gyeonggi-do | South Korea | 127.00889 | 37.29111 Gyeongju | Gyeongsangbuk-...
32
0
0
0
NCT01128114
6TERMINATED
2011-03-01
2010-06-01
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
[ 2 ]
7
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
true
This is an open-label, phase 1 study of a single cohort of neratinib (HKI-272) in combination with capecitabine.
null
Advanced Malignant Solid Tumors
Neratinib Capecitabine Combination Solid Tumor
null
1
arm 1: Neratinib + Capecitabine
[ 0 ]
2
[ 0, 0 ]
intervention 1: 240 mg once daily by mouth. intervention 2: 1500 mg/m\^2 twice daily by mouth.
intervention 1: Neratinib intervention 2: Capecitabine
2
Shizuoka | N/A | Japan | 138.38333 | 34.98333 Tokyo | N/A | Japan | 139.69171 | 35.6895
7
0
0
0
NCT01128842
1COMPLETED
2011-03-01
2010-04-01
Puma Biotechnology, 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 ]
50
RANDOMIZED
PARALLEL
null
2DOUBLE
false
0ALL
null
To investigate safety of BIBF 1120 in Japanese patients with idiopathic pulmonary fibrosis (IPF), with and without pirfenidone background treatment. To assess pharmacokinetics of BIBF 1120 in Japanese patients, with and without pirfenidone background treatment. To assess pharmacokinetics of pirfenidone in Japanese pa...
null
Idiopathic Pulmonary Fibrosis
null
4
arm 1: Low dose for cohort 1 arm 2: Middle dose for cohort 2 arm 3: High dose for cohort 3 arm 4: Placebo for cohort 1,2,3
[ 0, 0, 0, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Placebo BID for cohort 1,2,3 intervention 2: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 3: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively intervention 4: 50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
intervention 1: Placebo intervention 2: BIBF 1120 intervention 3: BIBF 1120 intervention 4: BIBF 1120
8
Bunkyo-ku,Tokyo | N/A | Japan | N/A | N/A Hamamatsu, Shizuoka | N/A | Japan | N/A | N/A Himeji, Hyogo | N/A | Japan | N/A | N/A Nagoya, Aichi | N/A | Japan | N/A | N/A Sakai, Osaka | N/A | Japan | N/A | N/A Seto, Aichi | N/A | Japan | N/A | N/A Shimotsuke,Tochigi | N/A | Japan | N/A | N/A Yokohama, Kanagawa | N/A | Jap...
50
0
0
0
NCT01136174
1COMPLETED
2011-03-01
2010-05-01
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
PARALLEL
0TREATMENT
2DOUBLE
true
0ALL
false
This study will evaluate the incidence of erythema and other local cutaneous irritation after administration of MK-0873 by patch or cream formulation in healthy participants and participants with mild psoriasis. Part I and Part II in healthy participants will be initiated prior to Part III in psoriasis participants. Th...
null
Plaque Psoriasis
null
10
arm 1: In Part I, healthy participants received skin patches containing nothing (plain patch), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg of MK- 0873) once daily for 21 days. arm 2: In Part I, healthy participants received skin patches containing nothing (plain patch)...
[ 0, 2, 0, 2, 0, 2, 0, 2, 0, 2 ]
5
[ 0, 0, 0, 0, 0 ]
intervention 1: MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873 intervention 2: MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873 intervention 3: Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches intervention 4: Placebo cream matching MK-0873 0.05%, 0.5%, or 2% intervention 5: Plain patch contain...
intervention 1: MK-0873 Patch intervention 2: MK-0873 Cream intervention 3: Placebo Patch intervention 4: Placebo Cream intervention 5: Plain patch
0
null
42
0
0
0
NCT01140061
1COMPLETED
2011-03-01
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 ]
229
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
1FEMALE
false
In order to find an optimal dose of arasertaconazole nitrate in the treatment of vulvovaginal candidiasis, a multicenter, randomized, double-blind, parallel, placebo-controlled study will be conducted to compare the therapeutic efficacy, safety and tolerability of three different doses of arasertaconazole nitrate (150 ...
null
Vulvovaginal Candidiasis
VVC candidiasis vaginal candidiasis
null
4
arm 1: placebo pessary, single dose arm 2: Arasertaconazole nitrate 150 mg pessary, single dose arm 3: Arasertaconazole nitrate 300 mg pessary, single dose arm 4: Arasertaconazole nitrate 600 mg pessary, single dose
[ 2, 0, 0, 0 ]
2
[ 0, 0 ]
intervention 1: Arasertaconazole nitrate pessary, placebo pessary intervention 2: placebo, single dose
intervention 1: arasertaconazole nitrate intervention 2: placebo
1
Barcelona | N/A | Spain | 2.15899 | 41.38879
229
0
0
0
NCT01144286
1COMPLETED
2011-03-01
2010-06-01
Ferrer Internacional 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
[ 3 ]
80
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
1SINGLE
false
0ALL
false
This study will compare how well a combination of borage and echium oils will reduce inflammation compared to fish oils and placebo oil in subjects that are diabetic or have metabolic syndrome.
null
Diabetes Metabolic Syndrome x
diabetes metabolic syndrome inflammation botanical oils
null
3
arm 1: borage/echium oil combination containing 0.85g/day SDA and 1.7 g/day GLA arm 2: Croda 18:12 fish oil arm 3: None
[ 0, 1, 2 ]
3
[ 0, 7, 7 ]
intervention 1: borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA intervention 2: 1.6g/day EPA and 1.08g/day DHA intervention 3: contains 4.5 g/day linoleic acid
intervention 1: borage/echium oil combination intervention 2: fish oil intervention 3: corn oil
1
Winston-Salem | North Carolina | United States | -80.24422 | 36.09986
71
0
0
0
NCT01145066
1COMPLETED
2011-03-01
2009-05-01
Wake Forest University Health Sciences
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
37
NON_RANDOMIZED
PARALLEL
0TREATMENT
0NONE
true
0ALL
true
The aim of this study is to evaluate (1) the safety and tolerability of escalating doses of rifapentine (RPT) administered daily by oral; (2) the effect of increasing doses of RPT on cytochrome P450 isoform 3A (CYP3A) enzyme metabolizing activity, using single-dose midazolam (MDZ); and (3) the effect of increasing dose...
On day 1, volunteers will receive a single dose of MDZ dosed at 15 mg delivered orally, and a 24-hour PK analysis of MDZ and its metabolite, 1-OH-midazolam (1-OH-MDZ) will be performed. RPT (or RIF) will be given as a single daily dose (5, 10, 15, or 20 mg/kg, depending on the dose cohort) on days 2-15 (14 doses). A 24...
Tuberculosis Tuberculosis, Pulmonary
Anti-infective agents Anti-bacterial agents Rifampin Rifapentine Midazolam Molecular mechanisms of pharmacological action Antitubercular agents Pharmacologic actions
null
6
arm 1: Rifampin + midazolam arm 2: RPT Cohort 1 - 5 mg/kg arm 3: RPT Cohort 2 - 10 mg/kg arm 4: RPT Cohort 3 - 15 mg/kg arm 5: RPT Cohort 4 - 20 mg/kg arm 6: RPT Cohort 5 - Maximal tolerated dose, if dose limiting toxicities are observed
[ 1, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 intervention 2: rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 intervention 3: rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and ...
intervention 1: Rifampin & midazolam intervention 2: rifapentine & midazolam intervention 3: rifapentine & midazolam intervention 4: rifapentine & midazolam intervention 5: rifapentine and midazolam intervention 6: rifapentine and midazolam
1
Baltimore | Maryland | United States | -76.61219 | 39.29038
33
0
0
0
NCT01162486
1COMPLETED
2011-03-01
2010-04-01
Johns Hopkins University
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
20
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
This study will evaluate the cerebrospinal fluid levels of trospium chloride (Sanctura XR®) and oxybutynin immediate release (Oxybutynin IR) on memory performance in patients with overactive bladder and age associated memory impairment.
null
Overactive Bladder
null
3
arm 1: Sanctura XR® (trospium chloride), 60mg once daily for 10 days arm 2: Oxybutynin IR (oxybutynin immediate release), 5 mg three times daily for 2 days arm 3: Oxybutynin IR placebo three times daily for 2 days
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: trospium chloride (60mg) once daily for 10 days intervention 2: oxybutynin IR (5 mg) three times daily for 2 days intervention 3: oxybutynin IR placebo three times daily for 2 days
intervention 1: trospium chloride intervention 2: oxybutynin IR intervention 3: oxybutynin IR placebo
1
Salt Lake City | Utah | United States | -111.89105 | 40.76078
20
0
0
0
NCT01178827
1COMPLETED
2011-03-01
2010-08-01
Allergan
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 4 ]
120
RANDOMIZED
PARALLEL
0TREATMENT
0NONE
false
0ALL
null
The purpose of this study is to provide data documenting the efficacy of daptomycin in elderly patients aged ≥ 65 years with complicated Skin and Soft Tissue Infections.
null
Infections
Skin infection Daptomycin Elderly Gram positive Complicated skin and soft tissue infections
null
2
arm 1: Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. arm 2: Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penic...
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days. Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days. intervention 2: Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Se...
intervention 1: Daptomycin intervention 2: Vancomycin or Semi-Synthetic Penicillins (SSPs)
17
Graz | N/A | Austria | 15.45 | 47.06667 Vienna | N/A | Austria | 16.37208 | 48.20849 Bochum | N/A | Germany | 7.21648 | 51.48165 Essen | N/A | Germany | 7.01228 | 51.45657 Homburg | N/A | Germany | 7.33867 | 49.32637 Magdeburg | N/A | Germany | 11.62916 | 52.12773 Mannheim | N/A | Germany | 8.46694 | 49.4891 Münster | ...
120
0
0
0
NCT01184872
1COMPLETED
2011-03-01
2010-03-01
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
[ 4 ]
1,152
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calc...
null
Psoriasis Vulgaris
null
4
arm 1: Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension arm 2: Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle arm 3: Calcipotriol 50 mcg/g in the topical suspension vehicle arm 4: The topical suspension vehicle alone
[ 0, 1, 1, 2 ]
4
[ 0, 0, 0, 0 ]
intervention 1: Topical suspension once daily for up to 8 weeks. intervention 2: Topical suspension once daily for up to 8 weeks. intervention 3: Topical suspension once daily for up to 8 weeks. intervention 4: Topical suspension once daily for up to 8 weeks.
intervention 1: Calcipotriol plus betamethasone intervention 2: Betamethasone-17,21-dipropionate intervention 3: Calcipotriene intervention 4: Topical suspension vehicle
59
Mobile | Alabama | United States | -88.04305 | 30.69436 Hot Springs | Arkansas | United States | -93.05518 | 34.5037 Anaheim | California | United States | -117.9145 | 33.83529 Lomita | California | United States | -118.31507 | 33.79224 Oceanside | California | United States | -117.37948 | 33.19587 San Diego | Californ...
1,152
0
0
0
NCT01188928
1COMPLETED
2011-03-01
2010-09-01
LEO Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
27
NA
SINGLE_GROUP
0TREATMENT
0NONE
false
0ALL
false
The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.
null
Paroxysmal Nocturnal Hemoglobinuria
Hemolytic Paroxysmal Nocturnal Hemoglobinuria Eculizumab PNH
null
1
arm 1: Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
[ 0 ]
1
[ 0 ]
intervention 1: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
intervention 1: Eculizumab
0
null
27
0
0
0
NCT01194804
1COMPLETED
2011-03-01
2008-04-01
Alexion 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
[ 5 ]
13
RANDOMIZED
PARALLEL
0TREATMENT
4QUADRUPLE
false
0ALL
false
How does Lusedra compare with current standard of care (midazolam) for minimal to moderate sedation for regional anesthesia blocks prior to orthopedic surgery?
The study overall is aimed at establishing the superiority of a single intravenous bolus-dose of Lusedra for routine use in preoperative regional blocks that avoids deeper levels of sedation and increased risk of nerve damage in an over-sedated individual. The shorter half-life of Lusedra should also demonstrate a supe...
Procedural Sedation Regional Anesthesia Block Orthopedic Surgery
Procedural sedation Regional Anesthesia block Orthopedic surgery Lusedra Fospropofol disodium Midazolam
null
3
arm 1: 10 mg/kg Lusedra initial bolus. arm 2: 6.5 mg/kg Lusedra initial bolus. arm 3: Placebo initial bolus with dose of midazolam based on patient's weight
[ 0, 1, 1 ]
4
[ 0, 0, 0, 0 ]
intervention 1: 10 mg/kg bolus intervention 2: 6.5 mg/kg bolus intervention 3: Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients \<60 kg; 1.5 mg for patients ≥60 kg to \<90 kg; or 2 mg for patients ≥90 kg intervention 4: All patients will receive a single dose ...
intervention 1: Fospropofol disodium intervention 2: Fospropofol disodium intervention 3: Placebo + Midazolam intervention 4: Fentanyl
1
Phoenix | Arizona | United States | -112.07404 | 33.44838
12
0
0
0
NCT01195103
6TERMINATED
2011-03-01
2011-02-01
Mayo Clinic
7OTHER
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 3 ]
70
RANDOMIZED
CROSSOVER
0TREATMENT
4QUADRUPLE
false
0ALL
false
The purpose of this trial is to determine if XPF-002 is safe and effective for the treatment of pain in subjects with Postherpetic Neuralgia
null
Postherpetic Neuralgia
Pain from Shingles, PHN, Postherpetic Neuralgia
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient intervention 2: Twice daily application of Placebo ointment
intervention 1: XPF-002 intervention 2: Placebo
24
Jonesboro | Arkansas | United States | -90.70428 | 35.8423 Lomita | California | United States | -118.31507 | 33.79224 Westlake Village | California | United States | -118.80565 | 34.14584 Bradenton | Florida | United States | -82.57482 | 27.49893 Naples | Florida | United States | -81.79596 | 26.14234 New Port Richey ...
125
0
0
0
NCT01195636
1COMPLETED
2011-03-01
2010-08-01
Xenon 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
[ 4 ]
244
RANDOMIZED
PARALLEL
0TREATMENT
1SINGLE
false
0ALL
false
The purpose of this study is to compare the clinical efficacy of once daily treatment for 4 weeks with Xamiol® gel (calcipotriol plus betamethasone) with twice daily treatment for 4 weeks with Calcipotriol Scalp Solution in patients with scalp psoriasis.
null
Scalp Psoriasis
null
2
arm 1: Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate) arm 2: Calcipotriol (as hydrate) 50 mcg/ml
[ 0, 1 ]
2
[ 0, 0 ]
intervention 1: Once daily application intervention 2: Twice daily application
intervention 1: Xamiol® gel intervention 2: Calcipotriol scalp solution
9
Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Beijing | N/A | China | 116.39723 | 39.9075 Chongqing | N/A | China | 106.55771 | 29.56026 Hangzhou | N/A | China | 120.16142 | 30.29365 Nanjing | N/A | China | 118.77778 | 32.06167 Shanghai | N/A | China | 121.45806 | 31.22222 Shan...
242
0
0
0
NCT01195831
1COMPLETED
2011-03-01
2010-09-01
LEO Pharma
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
14
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
true
0ALL
true
Purpose: Test whether intranasal administration of the neuropeptide, oxytocin, is effective in decreasing alcohol withdrawal symptoms, the number of bouts of withdrawal requiring standard medication treatment (lorazepam) and the amount of lorazepam required to control withdrawal bouts in individuals undergoing medical ...
Study Design: This will be a double-blind, placebo controlled comparison of the efficacy of twice daily intranasal administration of oxytocin and placebo (saline) in reducing alcohol withdrawal symptoms, the number of bouts of withdrawal during which symptoms are of sufficient magnitude requiring prn lorazepam treatmen...
Alcohol Withdrawal
oxytocin alcohol withdrawal lorazepam alcoholism intranasal administration CIWA-Ar
null
2
arm 1: Twice daily intranasal spray without oxytocin. arm 2: Twice daily intranasal oxytocin spray
[ 2, 0 ]
2
[ 0, 10 ]
intervention 1: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days intervention 2: 6 insufflations (0.1 metered dose/insufflation) twice daily
intervention 1: intranasal oxytocin spray intervention 2: intranasal spray without oxytocin
2
Chapel Hill | North Carolina | United States | -79.05584 | 35.9132 Raleigh | North Carolina | United States | -78.63861 | 35.7721
14
0
0
0
NCT01212185
1COMPLETED
2011-03-01
2010-07-01
University of North Carolina, Chapel Hill
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 ]
75
RANDOMIZED
CROSSOVER
7BASIC_SCIENCE
2DOUBLE
true
0ALL
false
The objective of this study is to investigate the relative contributions of nicotine replacement and sensorimotor replacement (i.e., smoking denicotinized cigarettes) on abstinence-induced smoking urges, withdrawal-related negative affect, psychiatric symptoms, cognitive task performance and 90-min ad libitum usual-bra...
This study used a mixed between- and within-subjects design to investigate the separate and combined effects of sensorimotor replacement for smoking (very low nicotine content \[VLNC\] cigarettes vs. no cigarettes) and transdermal nicotine replacement (42 mg nicotine \[NIC\] vs. placebo \[PLA\] patches) in smokers with...
Tobacco Use Disorder Schizophrenia
nicotine craving dual-diagnosis comorbidity
null
5
arm 1: 42 mg nicotine replacement plus sensorimotor replacement arm 2: inactive transdermal patches plus sensorimotor replacement arm 3: 42 mg nicotine replacement with no sensorimotor replacement arm 4: Double placebo: No nicotine or sensorimotor replacement arm 5: positive control: usual brand smoking
[ 1, 1, 1, 2, 1 ]
4
[ 5, 0, 0, 10 ]
intervention 1: denicotinized cigarettes intervention 2: 2 21-mg nicotine patches intervention 3: 2 placebo patches matched to 21-mg nicotine patches intervention 4: participant smokes usual brand of cigarette
intervention 1: sensorimotor replacement intervention 2: 42 mg transdermal nicotine replacement intervention 3: Placebo transdermal nicotine intervention 4: usual brand smoking
1
Providence | Rhode Island | United States | -71.41283 | 41.82399
75
0
0
0
NCT01213524
1COMPLETED
2011-03-01
2005-09-01
Brown 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 ]
63
RANDOMIZED
PARALLEL
7BASIC_SCIENCE
3TRIPLE
false
0ALL
false
The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease.
null
Chronic Obstructive Pulmonary Disease Lung Disease
Respiratory disease Chronic Obstructive Pulmonary Disease
null
2
arm 1: AZD2423 Oral Treatment for 28 days arm 2: Oral treatment for 28 days
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: 100 mg oral treatment once daily for 28 days intervention 2: Oral treatment once daily for 28 days
intervention 1: AZD2423 intervention 2: Placebo to AZD2423
6
Rousse | N/A | Bulgaria | 25.9534 | 43.84872 Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Bratislava | N/A | Slovakia | 17.10674 | 48.14816 Košice | N/A | Slovakia | 21.25808 | 48.71395 Prešov | N/A | Slovakia | 21.23393 | 48.99839 Žilina | N/A | Slovakia | 18.73941 | 49.22315
63
0
0
0
NCT01215279
1COMPLETED
2011-03-01
2010-10-01
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 ]
109
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
null
The purpose of this study is the evaluate the safety and tolerability of AZD5069 in patients with Chronic Obstructive Pulmonary Disease
null
Scientific Terminology Chronic Obstructive Pulmonary Disease (COPD) Laymen Terminology Chronic Bronchitis and Emphysema
Chronic Obstructive Pulmonary Disease, Neutrophil, Respiratory Disease
null
3
arm 1: Placebo dose arm 2: Treatment arm AZD5069 50mg arm 3: Treatment arm AZD5069 80mg
[ 2, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Oral dose bid intervention 2: Oral dose bid intervention 3: Oral dose bid
intervention 1: Placebo intervention 2: AZD5069 50mg intervention 3: AZD5069 80mg
8
Sofia | N/A | Bulgaria | 23.32415 | 42.69751 Berlin | N/A | Germany | 13.41053 | 52.52437 Großhansdorf | N/A | Germany | 10.28333 | 53.66667 Debrecen | N/A | Hungary | 21.62444 | 47.53167 Pécs | N/A | Hungary | 18.23083 | 46.0725 Százhalombatta | N/A | Hungary | 18.93878 | 47.32949 Szeged | N/A | Hungary | 20.14824 | 4...
87
0
0
0
NCT01233232
1COMPLETED
2011-03-01
2010-11-01
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 ]
20
NA
SINGLE_GROUP
9OTHER
0NONE
false
0ALL
false
Safety study with multiple oral doses of LY2608204 given to patients with type 2 diabetes. Study subjects will receive once daily doses of LY2608204 for a total treatment duration of up to 28 days. In this study, each patient will receive increasing doses of LY2608204 until reaching the highest dose that they can toler...
null
Diabetes Mellitus, Type 2
Diabetes glucokinase safety
null
1
arm 1: Oral capsules of LY2608204 given once daily at a starting dose of 160 milligram (mg), which may be titrated in 3 dose escalations to 240 mg, 320 mg and 400 mg, with a 7-day treatment duration at each dose level for up to 28 days total treatment.
[ 0 ]
1
[ 0 ]
intervention 1: Administered orally.
intervention 1: LY2608204
2
Miramar | Florida | United States | -80.23227 | 25.98731 Singapore | N/A | Singapore | 103.85007 | 1.28967
76
0
0
0
NCT01247363
1COMPLETED
2011-03-01
2010-11-01
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 ]
752
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
The main purpose of this study is to compare the efficacy and safety of aspirin, acetaminophen and caffeine (AAC) with sumatriptan and placebo in the acute treatment of migraine.
null
Pain, Migraine
Pain, Migraine
null
3
arm 1: AAC: 2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets arm 2: 1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets arm 3: 1 placebo tablet match...
[ 0, 1, 2 ]
3
[ 0, 0, 0 ]
intervention 1: 2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg) intervention 2: 100 mg Sumatriptan intervention 3: placebo
intervention 1: Aspirin, acetaminophen and caffeine intervention 2: Sumatriptan intervention 3: Placebo
20
Anaheim | California | United States | -117.9145 | 33.83529 San Francisco | California | United States | -122.41942 | 37.77493 Clearwater | Florida | United States | -82.8001 | 27.96585 DeLand | Florida | United States | -81.30312 | 29.02832 Jacksonville | Florida | United States | -81.65565 | 30.33218 Miami | Florida ...
670
0
0
0
NCT01248468
1COMPLETED
2011-03-01
2010-11-01
Novartis
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
27
NA
SINGLE_GROUP
0TREATMENT
0NONE
true
0ALL
false
This study will assess if giving LY2189265 at the same time as atorvastatin affects how the body absorbs atorvastatin.
null
Healthy Volunteers
null
1
arm 1: Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Period 1 and Period 2. Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on...
[ 0 ]
2
[ 0, 2 ]
intervention 1: Administered orally. intervention 2: Administered subcutaneously.
intervention 1: Atorvastatin intervention 2: LY2189265
1
Leeds | West Yorkshire | United Kingdom | -1.54785 | 53.79648
81
0
0
0
NCT01250834
1COMPLETED
2011-03-01
2010-12-01
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
0
0
0
0
0
0
0
0
0
[ 5 ]
140
RANDOMIZED
PARALLEL
0TREATMENT
2DOUBLE
false
0ALL
false
15 mg dextromethorphan hydrobromide will be better than placebo with respect to reducing the number of coughs over 6 hours and reducing the subjective severity of cough over 6 hours.
In light of protocol changes required due to methodological and operational issues, including background noise in cough recordings which could impact data interpretation, the study has been terminated.
Common Cold Infections, Upper Respiratory Tract
randomized parallel double-blind placebo-controlled cough efficacy safety dextromethorphan
null
2
arm 1: None arm 2: None
[ 0, 2 ]
2
[ 0, 0 ]
intervention 1: A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg) intervention 2: A single 10 mL dose of matching placebo syrup
intervention 1: Dextromethorphan intervention 2: Placebo
4
Pinellas Park | Florida | United States | -82.69954 | 27.8428 Indianapolis | Indiana | United States | -86.15804 | 39.76838 Gresham | Oregon | United States | -122.43148 | 45.49818 Nashville | Tennessee | United States | -86.78444 | 36.16589
107
0
0
0
NCT01257542
6TERMINATED
2011-03-01
2010-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
36
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
null
This study is designed to characterize the pharmacokinetic and pharmacodynamic effect of fospropofol disodium in comparison to propofol. In addition, the study will compare the maximum sedative effect, safety and tolerability of fospropofol disodium and propofol.
null
Anesthesia
null
3
arm 1: None arm 2: None arm 3: None
[ 0, 0, 0 ]
3
[ 0, 0, 0 ]
intervention 1: Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus. intervention 2: Two Treatment Periods: fospropofol di...
intervention 1: Fospropofol disodium, propofol intervention 2: Fospropofol disodium, propofol intervention 3: Fospropofol disodium, propofol
1
Durham | North Carolina | United States | -78.89862 | 35.99403
65
0
0
0
NCT01260142
1COMPLETED
2011-03-01
2010-11-01
Eisai Inc.
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
47
RANDOMIZED
CROSSOVER
0TREATMENT
0NONE
true
0ALL
false
The purpose of this study is to measure how much of the study drugs (clopidogrel and LY2216684) reach the blood stream and how long it takes the body to dispose of them and to determine how clopidogrel and LY2216684 might affect each other in the body. Information about any side effects that may occur will also be coll...
Clopidogrel is rapidly converted to R-130964 by the enzyme cytochrome P450 2C19 (CYP2C19). Enrollment in the study was limited to participants with specific genotypes of the CYP2C19 gene, including the \*1/\*1 genotype (CYP2C19 extensive metabolizers) and the \*1/\*17 or \*17/\*17 genotypes (CYP2C19 ultra-rapid metabol...
Major Depressive Disorder
null
2
arm 1: Period 1: a single 300-milligram (mg) dose of clopidogrel administered orally on Day 1 (Treatment 1). Period 2: an 18-mg dose of LY2216684 administered orally, once daily (QD) on Days 1 through 3, plus a single 300-mg dose of clopidogrel administered orally on Day 3 (Treatment 2). There was a washout period of...
[ 0, 0 ]
2
[ 0, 0 ]
intervention 1: None intervention 2: None
intervention 1: Clopidogrel intervention 2: LY2216684
1
Dallas | Texas | United States | -96.80667 | 32.78306
138
0
0
0
NCT01263093
1COMPLETED
2011-03-01
2010-12-01
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
0
0
0
0
0
0
0
0
0
[ 2 ]
16
RANDOMIZED
PARALLEL
0TREATMENT
3TRIPLE
false
0ALL
false
This is a randomized, double-blind, placebo-controlled study. The hypothesis for this study is that single oral doses of MK-8266 selected for this study are sufficiently safe and well tolerated by elderly male and elderly female participants with hypertension to permit continued clinical investigation.
Two panels, each consisting of eight participants (8 elderly males with mild to moderate hypertension in Panel A and 8 elderly females with mild to moderate hypertension in Panel B) will be randomized to receive either MK-8266 or matching placebo in a 3:1 ratio. Participants will receive single doses of MK-8266 or matc...
Hypertension
Hypertension
null
8
arm 1: MK-8266 single dose 0.3 mg arm 2: MK-8266 single dose 0.6 mg arm 3: MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours arm 4: Placebo to MK-8266 single dose arm 5: MK-8266 single dose 0.3 mg arm 6: MK-8266 single dose 0.6 mg arm 7: MK-8266 single dose 0.7 mg and then 0.3 mg after 10 hours arm 8: Placebo t...
[ 0, 0, 0, 2, 0, 0, 0, 2 ]
2
[ 0, 0 ]
intervention 1: Oral capsules, 0.1 mg potency intervention 2: Oral placebo capsules to match MK-8266 capsules
intervention 1: MK-8266 intervention 2: Placebo
0
null
48
0
0
0
NCT01263314
1COMPLETED
2011-03-01
2010-11-01
Merck Sharp & Dohme LLC
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 5 ]
13
RANDOMIZED
PARALLEL
2DIAGNOSTIC
2DOUBLE
false
0ALL
false
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
Subjects demonstrating a successful allergen response to a common allergen received the first study treatment and used as instructed for 5 days, after which they entered the Environmental Exposure Chamber (EEC) for a 3-hour exposure to a known concentration of the allergen. After waiting at least 7 days, subjects recei...
Allergic Conjunctivitis
Allergic conjunctivitis
null
2
arm 1: One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing. arm 2: One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each ...
[ 0, 2 ]
2
[ 0, 10 ]
intervention 1: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test. intervention 2: One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
intervention 1: Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol) intervention 2: Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
1
Fort Worth | Texas | United States | -97.32085 | 32.72541
13
0
0
0
NCT01282138
1COMPLETED
2011-03-01
2010-12-01
Alcon Research
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
[ 2 ]
20
RANDOMIZED
CROSSOVER
null
0NONE
true
0ALL
false
This Is A Study Of Bioavailability And Food Effect For Fesoterodine.
To estimate the bioavailability of three different 4 mg fesoterodine ER beads-incapsule formulations compared to 4 mg fesoterodine marketed ER tablets under fasting and fed conditions.
Overactive Bladder (OAB) With Symptoms of Frequency, Urgency, and Urgency
BIOAVAILABILITY FOOD EFFECT
null
6
arm 1: 4 mg fesoterodine IR beads in capsule under fasting condition arm 2: 4 mg fesoterodine 10% coated ER beads in capsule under fasting condition arm 3: 4 mg fesoterodine 15% coated ER beads in capsule under fasting condition. arm 4: 4 mg fesoterodine 20% coated ER beads in capsule under fasting condition. arm 5: 4 ...
[ 0, 0, 0, 0, 0, 0 ]
6
[ 0, 0, 0, 0, 0, 0 ]
intervention 1: single dose of beads in capsule intervention 2: single dose of beads in capsule intervention 3: single dose of beads in capsule intervention 4: single dose of beads in capsule intervention 5: single dose of tablet intervention 6: single dose of beads in capsule
intervention 1: fesoterodine intervention 2: fesoterodine intervention 3: fesoterodine intervention 4: fesoterodine intervention 5: fesoterodine intervention 6: fesoterodine
1
New Haven | Connecticut | United States | -72.92816 | 41.30815
120
0
0
0
NCT01286454
1COMPLETED
2011-03-01
2010-12-01
Pfizer
4INDUSTRY
false
false
false
null
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0
0