NCT00709371

Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

A Phase IIB, Multi-Center, Dose-Parallel, Randomized, Double-Blind, Monotherapy and Placebo-Controlled Safety and Efficacy Study of Zonisamide SR Plus Bupropion SR Combination Therapy in Subjects With Obesity

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 729 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is determine if the combination of zonisamide SR and bupropion SR are is more effective than either drug given alone or placebo in the treatment of obesity.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Zonisamide SR placebo/ bupropion SR placebo	2 placebo combination tablets twice daily for 16 weeks (maintenance period)
DRUG	Zonisamide SR placebo/ bupropion SR 360 mg/day	2 placebo and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
DRUG	Zonisamide SR 120 mg/day/ bupropion SR placebo	2 zonisamide SR 30 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
DRUG	Zonisamide SR 360 mg/day/ bupropion SR placebo	2 zonisamide SR 90 mg and placebo combination tablets, twice daily for 16 weeks (maintenance period)
DRUG	Zonisamide SR 120 mg/day/ bupropion SR 360 mg/day	2 zonisamide SR 30 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)
DRUG	Zonisamide SR 360 mg/day/ bupropion SR 360 mg/day	2 zonisamide SR 90 mg and bupropion SR 90 mg combination tablets, twice daily for 16 weeks (maintenance period)

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-04-01
• Completion: 2009-07-01
• First posted: 2008-07-03
• Last updated: 2012-11-29

Locations

20 sites across 1 country: United States