Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236600
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-10-07
Brief Title:
A Study on Efficacy and Safety of Topiramate in Maintaining Weight Loss in Obese Patients Following an Intensive Non-Pharmacologic Weight Loss Program
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None