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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00236613
First received: October 7, 2005
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: topiramate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Dose-Response Study to Assess the Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • The percent change in body weight from baseline (at the time of randomization) to Week 24.

Secondary Outcome Measures:
  • Changes from baseline to week 24 in total body weight, body mass index, fasting plasma glucose; incidence of adverse events over study.

Enrollment: 385
Study Start Date: September 2000
Study Completion Date: July 2001
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00236613

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00236613     History of Changes
Other Study ID Numbers: CR003709
Study First Received: October 7, 2005
Last Updated: December 2, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity
Hypertension
Hyperlipidemia
Body Mass Index

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Topiramate
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Anti-Obesity Agents

ClinicalTrials.gov processed this record on April 17, 2014