A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program

• Status: Completed
• Trial end date: 2002-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy and safety of topiramate 96mg and 192mg daily) with placebo in the treatment of obesity following an intensive non-pharmacologic weight loss program.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Body Mass Index (BMI) >= 33 and < 50 kg/m2

• BMI >=30 and < 50 kg/m2 if patients have 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)

• Randomization criteria: Weight reduction of more than 8% of enrollment body weight during the eight week run-in phase

Exclusion Criteria:

• Prior exposure, known contraindication, or hypersensitivity to topiramate

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

• A diagnosis of diabetes (except those diagnosed during the enrollment if no medications are needed)

• 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 or liposuction

• History of malignancy within last 5 years

• History of an eating disorder