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A Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in a Behavior Modification Program

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00456521
First received: April 3, 2007
Last updated: October 30, 2012
Last verified: October 2012
History of Changes
  Purpose

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: Intensive group lifestyle modification counseling
Drug: PBO
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone SR/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Change in Body Weight [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve a Weight Decrease of ≥5% [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect on selected obesity-associated cardiovascular risk factors, including serum triglycerides, HDL and LDL cholesterol, waist circumference, glucose and insulin levels. [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: No ]
  • Percentage of Subjects Who Achieve a Weight Decrease of ≥10% [ Time Frame: Baseline, 56 weeks ] [ Designated as safety issue: No ]

Enrollment: 793
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32
Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling
 Drug: naltrexone SR/bupropionSR combination
naltrexone SR 32 mg/bupropion SR 360 mg per day
Behavioral: Intensive group lifestyle modification counseling
Group lifestyle modification counseling
Placebo Comparator: PBO
placebo with intensive group behavioral lifestyle modification counseling
 Behavioral: Intensive group lifestyle modification counseling
Group lifestyle modification counseling
Drug: PBO
Other Name: placebo

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female and male subjects, 18 to 65 years of age
  • Have body mass index (BMI) between 30 and 45kg/m2 for subjects with uncomplicated obesity, and 27 and 45kg/m2 for subjects with obesity and controlled hypertension and/or dyslipidemia
  • Non-smoker and no use of tobacco or nicotine products for at least 6 months
  • Normotensive(< 140/90 mm Hg), some anti-hypertensive medications are allowed
  • LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL
  • Women of child bearing potential must have negative serum pregnancy, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after stopping study drug

Exclusion Criteria:

  • Obesity of known endocrine origin such as untreated hypothyroidism or Polycystic Ovary Syndrome
  • Serious medical condition
  • Serious psychiatric illness
  • Type I or Type II diabetes mellitus
  • Need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
  • On prohibited concomitant medication
  • History of surgical or device (e.g. lap band) intervention for obesity
  • History of seizures or predisposition to seizures
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456521

Locations
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
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Frank Greenway, MD Pennington Biomedical Research Center, Baton Rouge, Louisiana
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00456521     History of Changes
Other Study ID Numbers: NB-302, COR-BMOD
Study First Received: April 3, 2007
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Obesity
Behavior Modification

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013