Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236639
Status:
COMPLETED
Last Update Posted:
2010-04-28
First Post:
2005-10-07
Brief Title:
A Study on Efficacy and Safety of Topiramate in the Treatment of Patients With Obesity
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
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
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 96 192 and 256mg daily with placebo in long-term treatment of obesity
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 waisthip 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
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