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A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program

NCT00456521 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 793

Last updated 2014-12-17

Study results available
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Summary

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR 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.

Conditions

Interventions

DRUG

Naltrexone SR 32 mg/ bupropion SR 360 mg/ day

DRUG

Placebo

BEHAVIORAL

Intensive group lifestyle modification counseling

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00456521 on ClinicalTrials.gov