Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00236613
Status:
COMPLETED
Last Update Posted:
2010-12-03
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:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 safety and effectiveness of topiramate 64mg 96mg 192mg and 384mg daily with placebo in the treatment of obesity
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 waisthip 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
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