drugset / Trial / NCT00339014

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

NCT00339014

Phase 2 Completed 611 enrolled Orexigen Therapeutics, Inc
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bupropion Small molecule 280 mg
Comparator Bupropion Small molecule 360 mg
Comparator Zonisamide Other / unclassified 120 mg
Comparator Zonisamide Other / unclassified 240 mg
Comparator Zonisamide Other / unclassified 360 mg

Indications