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Sponsored by: |
Orexigen Therapeutics, Inc |
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Information provided by: | Orexigen Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00532779 |
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 |
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Group 1: Active Comparator
Naltrexone SR 16 mg/Bupropion SR 360 mg /day
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Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
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Group 2: Active Comparator
Naltrexone SR 32 mg/Bupropion SR 360 mg /day
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Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
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Group 3: Placebo Comparator
Placebo
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Drug: naltrexone SR/bupropion SR
naltrexone 16 mg/bupropion SR 360 mg/day naltrexone 32 mg/bupropion SR 360 mg/day
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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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Principal Investigator: | Frank Greenway, MD | Pennington Biomedical Research Center, Baton Rouge, Louisiana |
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 |
Health Authority: | United States: Food and Drug Administration |
Obesity |
Body Weight Signs and Symptoms Obesity Dopamine Naltrexone |
Bupropion Nutrition Disorders Overweight Overnutrition |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotic Antagonists Physiological Effects of Drugs Psychotropic Drugs Pharmacologic Actions |
Sensory System Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |