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A Dose Parallel, Randomized, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of Multiple Regimens of the Combination of Zonisamide CR Plus Bupropion SR in the Treatment of Subjects With Uncomplicated Obesity
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.
Details
| Lead sponsor | Orexigen Therapeutics, Inc |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 611 |
| Start date | 2006-05 |
| Completion | 2007-08 |
Conditions
- Obesity
Interventions
- Zonisamide CR and Bupropion SR
- Placebo
Primary outcomes
- % change in total body weight as measured between baseline and week 24 (ITT-LOCF analysis) — Baseline to week 24
Countries
United States