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

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the safety and effectiveness of topiramate (64mg, 96mg, 192mg, and 384mg daily) with placebo in the treatment of obesity.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Topiramate

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) >=30 and <50

• BMI >= 27 and < 50 if patient has controlled hypertension or abnormal blood lipids

• Stable weight

• Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test)

Exclusion Criteria:

• Known contraindication, or hypersensitivity to topiramate

• Exposure to any other experimental drug or device within last 30 days

• A diagnosis of diabetes

• History or evidence of clinically significant liver disease, cardiovascular disease, uncontrolled hypertension or high thyroid levels

• History of obesity with known cause

• History or family history of kidney stones

• History of weight loss surgery

• History of malignancy within last 5 years