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

NCT00236600 | Completed Phase 3

• 1 other identifier: CR003706
• Study Type: interventional
• Target: 561
• Locations: 0 countries
• Sites: N/A

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 program.

Conditions

Obesity

Keywords

Obesity; Hypertension; Hyperlipidemia; Type 2 Diabetes; Life style modification

Outcome Measures

Primary Outcomes (1)

• The percent change in body weight from the enrollment visit to week 60.

Secondary Outcomes (1)

• Change from baseline to week 60 in absolute change in body weight, body mass index, waist circumference, fasting lipid profile; safety evaluations over study.

Interventions

topiramate DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related 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. doi: 10.1038/oby.2004.206.

  PMID: 15536230 RESULT

MeSH Terms

Conditions

Obesity; Hypertension; Hyperlipidemias; Diabetes Mellitus, Type 2

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 7, 2005
• First Posted: October 12, 2005
• Study Start: August 1, 2000
• Study Completion: June 1, 2002
• Last Updated: April 28, 2010

Record last verified: 2010-04