NCT00481975

Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 289 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity
• Eating Disorders

Interventions

Type	Name	Description
DRUG	rimonabant (SR141716)

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-08-01
• Completion: 2005-08-01
• First posted: 2007-06-04
• Last updated: 2009-04-07

Locations

7 sites across 7 countries: United States, Finland, France, Netherlands, Portugal, Sweden, Switzerland