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:
NCT00236639
First received: October 7, 2005
Last updated: April 26, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: topiramate
Phase 3

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 the baseline (randomization) to Week 60 (after one year of maintenance therapy).

Secondary Outcome Measures:
  • 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.

Enrollment: 1293
Study Start Date: July 2000
Study Completion Date: June 2002
Detailed Description:

Topiramate is not approved for the treatment of obesity. This double-blind, placebo-controlled study assesses long-term effectiveness and safety of topiramate in patients with obesity. After completing 6 weeks of run-in phase (a single-blind placebo-treatment phase during which patients begin non-pharmacological therapy), patients will be randomized to receive either topiramate or placebo. Topiramate group will receive 16mg of topiramate and the dose will be titrated over 8 weeks. Patients will then receive two years of treatment. Effectiveness will be evaluated by body weight, Body Mass Index (BMI), anthropometric measurements (waist circumference, hip circumference, waist/hip ratio), fasting lipid profile, fasting plasma glucose, HbA1c, fasting uric acid, fasting insulin, blood pressures, body fat compositions, mass of left ventricle of the heart (as measured by echocardiography), and Health Related Quality of Life scores. Safety evaluation (incidence of adverse events, laboratory tests, electrocardiogram, vital signs) will be performed throughout the study. The study hypothesis is that topiramate will be effective in achieving and maintaining weight reduction in obese patients. During the initial 8 weeks, the doses of topiramate or placebo will be gradually increased to the target dose (either 96mg, 192mg, or 256mg daily by mouth) and the doses will be maintained for 2 years.

  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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236639

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:
ClinicalTrials.gov Identifier: NCT00236639     History of Changes
Other Study ID Numbers: CR003721
Study First Received: October 7, 2005
Last Updated: April 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Obesity
Hypertension
Hyperlipidemia
Type 2 Diabetes Mellitus
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 September 18, 2014