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Sponsored by: |
Orexigen Therapeutics, Inc |
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Information provided by: | Orexigen Therapeutics, Inc |
ClinicalTrials.gov Identifier: | NCT00456521 |
The purpose of this study is to determine whether a combination of 2 drugs is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Condition | Intervention | Phase |
---|---|---|
Obesity |
Drug: naltrexone SR/bupropionSR combination Behavioral: Group lifestyle modification counseling |
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 Naltrexone SR/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program |
Enrollment: | 793 |
Study Start Date: | April 2007 |
Study Completion Date: | December 2008 |
Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator |
Drug: naltrexone SR/bupropionSR combination
naltrexone SR 32 mg/bupropion SR 360 mg per day
Behavioral: Group lifestyle modification counseling
Group lifestyle modification counseling
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Group 2: Placebo Comparator |
Behavioral: Group lifestyle modification counseling
Group lifestyle modification counseling
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The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg. Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study will evaluate weight loss in subjects participating in such a comprehensive program who receive a combination of naltrexone SR and bupropion SR or placebo.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCSD: Dept of Family & Preventive Medicine | |
La Jolla, California, United States, 92093 | |
United States, Colorado | |
Center for Human Nutrition, University of Colorado Health Services Center | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States, 32611 | |
United States, Missouri | |
Washington Univ. Center for Human Nutrition | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
NY Obesity Research Center | |
New York, New York, United States, 10025 | |
United States, Pennsylvania | |
Center for Obesity Research and Education | |
Philadelphia, Pennsylvania, United States, 19140 | |
Center for Weight & Eating Disorder | |
Philadelphia, Pennsylvania, United States, 19104 | |
United States, South Carolina | |
MUSC Weight Mnagement Center | |
Charleston, South Carolina, United States, 29425 |
Principal Investigator: | Frank Greenway, MD | Pennington Biomedical Research Center, Baton Rouge, Louisiana |
Responsible Party: | Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD ) |
Study ID Numbers: | NB-302 |
Study First Received: | April 3, 2007 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00456521 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Obesity Behavior Modification |
Dopamine Uptake Inhibitors Obesity Neurotransmitter Agents Narcotic Antagonists Psychotropic Drugs Overweight Narcotics Body Weight Signs and Symptoms |
Dopamine Bupropion Naltrexone Nutrition Disorders Dopamine Agents Overnutrition Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Antidepressive Agents |
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 |