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| Sponsor: | Orexigen Therapeutics, Inc |
|---|---|
| Information provided by: | Orexigen Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00532779 |
Purpose
The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Drug: naltrexone SR/bupropion SR |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3 Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects |
| Estimated Enrollment: | 1650 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | April 2009 |
| Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Group 1: Active Comparator
Naltrexone SR 16 mg/Bupropion SR 360 mg /day
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
|
Group 2: Active Comparator
Naltrexone SR 32 mg/Bupropion SR 360 mg /day
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
|
Group 3: Placebo Comparator
Placebo
|
Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
|
Two Phase II clinical trials have demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study will investigate the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with obesity and hypertension and/or dyslipidemia.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| SelfCenter, PC | |
| Fairhope, Alabama, United States, 36532 | |
| Radiant Research | |
| Birmingham, Alabama, United States, 35209 | |
| United States, Arizona | |
| Radiant Research, Phoenix Southeast | |
| Chandler, Arizona, United States, 85225 | |
| United States, California | |
| Scripps Clinic Del mar | |
| San Diego, California, United States, 92130 | |
| Advance Clinical Research Institute | |
| Orange, California, United States, 92869 | |
| VA San Diego Healthcare System | |
| San Diego, California, United States, 92161 | |
| Advanced Clinical Research Institute | |
| Anaheim, California, United States, 92801 | |
| United States, Florida | |
| Miami Research Associates | |
| Miami, Florida, United States, 33143 | |
| University Clinical Research | |
| Pembroke Pines, Florida, United States, 33024 | |
| United States, Georgia | |
| CSRA Partners in Health, Inc | |
| Augusta, Georgia, United States, 30909 | |
| Georgia Clinical Research | |
| Atlanta, Georgia, United States, 30308 | |
| United States, Hawaii | |
| East-West Medical Research Institute | |
| Honolulu, Hawaii, United States, 96814 | |
| United States, Illinois | |
| Radiant Research | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Welborn Clinic | |
| Evansville, Indiana, United States, 47713 | |
| United States, Kansas | |
| Radiant Research Kansas City | |
| Overland Park, Kansas, United States, 66202 | |
| United States, Kentucky | |
| Central Kentucky Research Associates, Inc. | |
| Lexington, Kentucky, United States, 40509 | |
| United States, Louisiana | |
| Medical Research Institute | |
| Slidell, Louisiana, United States, 70458 | |
| Pennington Biomedical Research Center | |
| Baton Rouge, Louisiana, United States, 70808 | |
| United States, Maryland | |
| Health Trends Research, LLC | |
| Baltimore, Maryland, United States, 21209 | |
| United States, Massachusetts | |
| FutureCare Studies | |
| Springfield, Massachusetts, United States, 01103 | |
| United States, Nevada | |
| Center for Nutrition and Metabolic Diseases | |
| Reno, Nevada, United States, 89557 | |
| United States, North Carolina | |
| Center for Nutrition and Preventive Medicine | |
| Charlotte, North Carolina, United States, 28211 | |
| Wake Research Associates, LLC | |
| Raleigh, North Carolina, United States, 27612 | |
| United States, Ohio | |
| Rapid Medical Research, Inc. | |
| Cleveland, Ohio, United States, 44122 | |
| Central Ohio Nutrition Center, Inc. | |
| Columbus, Ohio, United States, 43213 | |
| United States, Oklahoma | |
| Lynn Health Science Institute | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Summit Research Network (Oregon), Inc. | |
| Portland, Oregon, United States, 97210 | |
| United States, Tennessee | |
| Jackson Clinic, PA | |
| Jackson, Tennessee, United States, 38305 | |
| Internal Medicine Associates of Cordova | |
| Cordova, Tennessee, United States, 38018 | |
| United States, Texas | |
| Baylor Endocrine Center | |
| Dallas, Texas, United States, 75246 | |
| North San Antonio Health Care Assoc. | |
| San Antonio, Texas, United States, 78218 | |
| Covance Clinical Research Unit Austin | |
| Austin, Texas, United States, 78752 | |
| Radiant Research | |
| Dallas, Texas, United States, 75231 | |
| Radiant Research | |
| San Antonio, Texas, United States, 78217 | |
| Principal Investigator: | Frank Greenway, MD | Pennington Biomedical Research Center, Baton Rouge, Louisiana |
More Information
| Responsible Party: | Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD ) |
| Study ID Numbers: | NB-301 |
| Study First Received: | September 19, 2007 |
| Last Updated: | April 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00532779 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Obesity |
|
Dopamine Uptake Inhibitors Obesity Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotic Antagonists Physiological Effects of Drugs Psychotropic Drugs Overweight Pharmacologic Actions Body Weight Signs and Symptoms |
Sensory System Agents Therapeutic Uses Naltrexone Bupropion Nutrition Disorders Dopamine Agents Overnutrition Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |