A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

385 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2001-07-31

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Obesity Hypertension Hyperlipidemia Body Mass Index

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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topiramate

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References

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Bray GA, Hollander P, Klein S, Kushner R, Levy B, Fitchet M, Perry BH. A 6-month randomized, placebo-controlled, dose-ranging trial of topiramate for weight loss in obesity. Obes Res. 2003 Jun;11(6):722-33. doi: 10.1038/oby.2003.102.

Reference Type RESULT

PMID: 12805393 (View on PubMed)

Loring DW, Williamson DJ, Meador KJ, Wiegand F, Hulihan J. Topiramate dose effects on cognition: a randomized double-blind study. Neurology. 2011 Jan 11;76(2):131-7. doi: 10.1212/WNL.0b013e318206ca02. Epub 2010 Dec 9.

Reference Type DERIVED

PMID: 21148119 (View on PubMed)

Other Identifiers

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CR003709

Identifier Type: -

Identifier Source: org_study_id