A Study of Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity
June 6, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
The Safety and Efficacy of Topiramate in Male Patients With Abdominal Obesity: A 6-Month Double-Blind, Randomized, Placebo-Controlled Study With a 6-Month Open-Label Extension
The purposes of this study are to compare the effects of Topiramate and placebo on abdominal visceral fat accumulation at 6 months and to evaluate the safety of Topiramate for up to 12 months of continued treatment in male patients with abdominal obesity.
Study Overview
Detailed Description
Topiramate is not approved for the treatment of obesity.
This study is a 6-month randomized, double-blind placebo-controlled study, followed by a 6-month open-label extension study to evaluate the effect of Topiramate on abdominal visceral fat accumulation, a clinical surrogate known to be associated with the complications of obesity such as increased incidence of Type 2 diabetes mellitus, hypertension, and dyslipidemia, and their associated morbidities.
Patients will be randomized to receive either daily Topiramate or placebo.
Effectiveness will be measured by multiple parameters such as abdominal visceral fat (assessed by computed tomography), total and subcutaneous abdominal fat, body composition, body weight, body mass index, glucose tolerance, lipid profile, blood pressure, Topiramate plasma concentration, or 24 hours energy expenditure (selected patients).
Safety evaluation (adverse events, vital signs, 12-lead ECG, clinical laboratory tests) will be conducted throughout the study.
The study hypothesis is that Topiramate is effective in reducing abdominal visceral fat in male patients and well tolerated.
After the initial 12-week titration phase, patients will receive either Topiramate (200mg twice daily or the maximum dose tolerated) or placebo by mouth for 6-months.
Then, patients will receive Topiramate (200mg twice daily or the maximum tolerated dose) for 6-months during the open-label phase.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- BMI >= 27 and =< 40
- a waist circumference >= 100 cm (39.4 inches)
- Baseline weight must be stable (varying no more than 4 kg (8.8 lbs)) for at least two months prior to enrollment
- Must be sedentary (less than one session of continuous moderate physical activity of 30 min/week)
- Must have blood lipid disorder
- Must be non-smokers
Exclusion Criteria:
- Patients with endocrine disease or other physical causes of obesity
- Patients with significantly abnormal hepatic liver function tests or renal disease
- History of schizophrenia, psychotic, or major affective disorder
- History of epilepsy
- History of eating disorders
- History of any other significant medical conditions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The mean change from baseline to Month 6 in abdominal visceral fat as assessed by computed tomography; the safety of Topiramate for up to 12 months of continued treatment in male subjects with abdominal obesity.
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Secondary Outcome Measures
Outcome Measure |
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Mean change and percent change in body weight, and mean change in total abdominal fat, subcutaneous abdominal fat, body composition, and body mass index from baseline to Month 6.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1998
Study Completion (Actual)
January 1, 2002
Study Registration Dates
First Submitted
September 30, 2005
First Submitted That Met QC Criteria
September 30, 2005
First Posted (Estimate)
October 4, 2005
Study Record Updates
Last Update Posted (Estimate)
June 8, 2011
Last Update Submitted That Met QC Criteria
June 6, 2011
Last Verified
April 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR003724
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.