A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive, Non-Pharmacologic Weight Loss Program

Obesity Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Efficacy and Safety of Topiramate in Weight Loss Maintenance in Obese Patients Following Participation in an Intensive, Non-Pharmacologic Weight Loss Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236600
• Other study ID #: CR003706
• Status: Completed
• Phase: Phase 3
• First received: October 7, 2005
• Last updated: April 26, 2010
• Start date: August 2000
• Est. completion date: June 2002

Study information

• Verified date: April 2010
• Source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 program.

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 in obese patients. Topiramate is not approved for the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of topiramate in maintaining weight loss achieved by an intensive non-drug weight reduction program. Enrolled patients will undergo run-in phase (8 weeks of intensive non-drug weight reduction therapy consisting of a low calorie diet, a behavioral modification program, and an exercise program). Those patients who achieve weight loss of >= 8% of enrollment body weight and meeting the eligibility criteria will be randomized to either 96mg or 192mg of topiramate, or placebo. After 8 weeks of dose titration, the patients will receive one year of treatment. Effectiveness will be assessed by body weight, Body Mass Index (BMI), number and proportion of 5%, 10% and 15% weight loss responders, number and proportion of patients who maintain 50%, 75%, and 100% of weight lost during run-in phase, waist and hip circumferences, fasting lipid profile, fasting plasma glucose, HbA1c, fasting insulin, two-hour glucose tolerance test, uric acid level, blood pressure, body composition, echocardiography, and Health Related Quality of Life scores. Safety evaluations (incidence of adverse events, electrocardiograms, vital signs, etc) will be performed throughout the study. The study hypothesis is that topiramate is more effective than placebo in maintaining weight reduction in obese patients following intensive non-drug weight reduction program. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target doses (either 96mg or 192mg) daily by mouth and the doses will be maintained for one year.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 561
• Est. completion date: June 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• topiramate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

References & Publications (1)

Astrup A, Caterson I, Zelissen P, Guy-Grand B, Carruba M, Levy B, Sun X, Fitchet M. Topiramate: long-term maintenance of weight loss induced by a low-calorie diet in obese subjects. Obes Res. 2004 Oct;12(10):1658-69. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percent change in body weight from the enrollment visit to week 60.
Secondary	Change from baseline to week 60 in absolute change in body weight, body mass index, waist circumference, fasting lipid profile; safety evaluations over study.