A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Phase 3 Completed 1293 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.

Timeline

Start: 2000-07
Primary completion: —
Completion: 2002-06

Outcome

Met primary endpoint

paper 96, 192, and 256 mg/day treatment groups lost 7.0, 9.1, and 9.7%, respectively (P<0.001, MITT, last observation carried forward). PMID 15486569 ↗

Publications

Results Wilding J, Van Gaal L, Rissanen A, Vercruysse F, Fitchet M; OBES-002 Study Group. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1399-410. doi: 10.1038/sj.ijo.0802783.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Topiramate	Small molecule	96 mg	Oral
Subject	Topiramate	Small molecule	192 mg	Oral
Subject	Topiramate	Small molecule	256 mg	Oral