Status:
COMPLETED
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2001
Estimated Enrollment :
385 Patients enrolled
Trial Details
Trial ID
NCT00236613
Start Date
September 1 2000
End Date
July 1 2001
Last Update
December 3 2010
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