A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Dose-Response Study to Assess the Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Enrollment
- 385
- Primary Endpoint
- The percent change in body weight from baseline (at the time of randomization) to Week 24.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief 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.
Detailed Description
Topiramate is not approved for the treatment of obesity. This is a randomized, double-blind, placebo-controlled, multicenter study to assess the safety and effectiveness of topiramate in treatment of obese patients. Patients will receive 24 weeks of treatment by topiramate or placebo, followed by 2 week taper and a safety follow-up. Effectiveness will be determined by changes from baseline to week 24 in body weight, body mass index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ration), fasting lipid profiles, fasting plasma glucose, HbA1c (shows average blood sugar level over months), fasting uric acid, fasting insulin, and blood pressures. Safety evaluations (incidence of adverse events, physical examinations, 12 lead ECGs, vital signs, Computerized Neuropsychological Test Battery) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients and is well tolerated. The patients will be randomized to receive either topiramate (64, 96, 192, or 384 mg daily) or placebo daily by mouth for 24 weeks.
Investigators
Eligibility 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
Outcomes
Primary Outcomes
The percent change in body weight from baseline (at the time of randomization) to Week 24.
Secondary Outcomes
- Changes from baseline to week 24 in total body weight, body mass index, fasting plasma glucose; incidence of adverse events over study.