Status:
COMPLETED
A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Obesity
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 progra...
Detailed Description
Although dietary modification coupled with increased exercise is the preferred treatment of obesity, these lifestyle changes alone are often insufficient in achieving and maintaining weight reduction ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2002
Estimated Enrollment :
561 Patients enrolled
Trial Details
Trial ID
NCT00236600
Start Date
August 1 2000
End Date
June 1 2002
Last Update
April 28 2010
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