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

NCT00236639 | Completed Phase 3

• 1 other identifier: CR003721
• Study Type: interventional
• Target: 1,293
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the efficacy and safety of topiramate (96, 192, and 256mg daily) with placebo in long-term treatment of obesity.

Conditions

Obesity

Keywords

Obesity; Hypertension; Hyperlipidemia; Type 2 Diabetes Mellitus; Body Mass Index

Outcome Measures

Primary Outcomes (1)

• The percent change in body weight from the baseline (randomization) to Week 60 (after one year of maintenance therapy).

Secondary Outcomes (1)

• Changes from either baseline to Week 60 and/or Week 112, or enrollment to Week 60 and/or Week 112 in absolute body weight, Body Mass Index (BMI), body measurements, fasting lipid profile.

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) \>= 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)

You may not qualify if:

• Known contraindication, or hypersensitivity to topiramate
• 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 of weight loss surgery or liposuction
• History of malignancy within last 5 years

Sponsors & Collaborators

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

Related Publications (1)

• Wilding J, Van Gaal L, Rissanen A, Vercruysse F, Fitchet M; OBES-002 Study Group. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1399-410. doi: 10.1038/sj.ijo.0802783.

  PMID: 15486569 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: July 1, 2000
• Study Completion: June 1, 2002
• Last Updated: April 28, 2010

Record last verified: 2010-04