Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00231647
Status:
COMPLETED
Last Update Posted:
2011-06-08
First Post:
2005-09-30
Brief Title:
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese Type 2 Diabetic Subjects Managed With Diet or Metformin
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 Study to Assess the Efficacy and Safety of Topiramate OROS Controlled-Release in the Treatment of Obese Type 2 Diabetic Subjects Managed With Diet or Metformin
Status:
COMPLETED
Status Verified Date:
2011-01
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 evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese type 2 diabetic patients managed with diet alone or combined with metformin
Detailed Description:
Topiramate is not approved for the treatment of obesity Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes A novel controlled-release formulation of topiramate using OROS technology has the potential for better efficacy and safety in the treatment of obesity This double-blind placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes The study consists of 2 screening visits a baseline visit 7-week titration phase topiramate dose will be increased from 25mg daily to 175mg daily 9-week maintenance phase 2-week taper phase and a 2-week follow-up Effectiveness will be evaluated by the percent change in body weight body mass index and anthropometric measurements waist and hip circumferences and their ratio Safety evaluations incidence and severity of adverse events physical measurements and clinical laboratory tests will be conducted throughout the study The study hypothesis is that topiramate 175 mg daily when administered as the OROS controlled-release formulation is effective in terms of percent reduction in body weight from baseline to week 16 and safe as compared with placebo in the treatment of obese type 2 diabetic patients managed with either diet alone or combined with metformin During the titration phase topiramate in the OROS controlled-release formulation will be gradually increased to 175mg daily by mouth and the dose will be maintained for 9 weeks and then slowly discontinued over 2 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