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Safety and Efficacy of Different Combinations of Zonisamide-CR Plus Bupropion-SR to Treat Uncomplicated Obesity

NCT00339014 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 611

Last updated 2008-04-22

No results posted yet for this study

Summary

The purpose of this study is to determine which of seven combinations of Zonisamide CR and Bupropion SR gives the best weight loss and is safe and well tolerated for the treatment of obesity not associated with the complications of obesity such as diabetes. In a previous study, the combination of zonisamide and bupropion SR was shown to be effective for weight loss compared to either zonisamide, bupropion SR alone or placebo. It is thought that by adjusting the doses of each drug, giving zonisamide in a controlled release (CR) form and increasing the doses more slowly, more weight loss and less side effects can be attained.

Conditions

Interventions

DRUG

Zonisamide CR and Bupropion SR

Zonisamide SR and Bupropion SR

OTHER

Placebo

Identical placebo

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Frank Greenway, MD · Pennington Biomedical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2007-08-31
Completion
2007-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00339014 on ClinicalTrials.gov