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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Eating Disorders

Obesity

Treatments

Drug: rimonabant (SR141716)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00481975

ACT3801

Details and patient eligibility

About

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.

Enrollment

289 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Body Mass Index (BMI) ≥30 to ≤45 kg/m²
Diagnosis of eating disorder using The Questionnaire on Eating and Weight Patterns (QEWP-R) for diagnosing Eating Behaviors

Exclusion criteria

History of surgical procedures for weight loss
Treatment with anti-obesity drugs within 3 months prior to screening visit
Presence or history of Diagnostic and Statistical Manual of Mental Disorders (4th edition)(DSM IV) bulimia or anorexia nervosa

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.