Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481975
Status:
COMPLETED
Last Update Posted:
2009-04-07
First Post:
2007-06-01
Brief Title:
Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Randomized Double-Bind Placebo-Controlled Parallel-Group Fixed-Dose Multicenter Study to Assess Efficacy and Safety of Rimonabant 20 mg Versus Placebo on Weight Loss and Frequency of Binge Episodes in Obese Patients With Food Craving
Status:
COMPLETED
Status Verified Date:
2009-04
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 primary objective is to assess the effect of rimonabant compared to placebo on weight loss over a period of 6 months when prescribed with a mild hypocaloric diet in obese patients with binge eating disorder
The secondary objectives are
to assess the effect of rimonabant on the number of binge episodes per week to assess the effect of rimonabant on eating behavior using the Binge Eating Scale BES and Three Factor Eating Questionnaire TFEQ
to evaluate the safety and tolerability of rimonabant over a period of 6 months
The secondary objectives are
to assess the effect of rimonabant on the number of binge episodes per week to assess the effect of rimonabant on eating behavior using the Binge Eating Scale BES and Three Factor Eating Questionnaire TFEQ
to evaluate the safety and tolerability of rimonabant over a period of 6 months
Detailed Description:
None
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