Clinical trial NCT00481975: Efficacy and Safety of Rimonabant on Weight Loss and Frequency of Binge Episodes in Obese Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Eating Disorders
Keywords: binge eating
eating disorders
obesity
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-04
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in body weight from baseline to Day 180 visit
Secondary outcomes:
measure: Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index
measure: Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis Administrative Office
state: New Jersey
city: Helsinki
country: Finland
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Gouda
country: Netherlands
facility: Sanofi-Aventis Administrative Office
city: Porto Salvo
country: Portugal
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
citation: Pataky Z, Gasteyger C, Ziegler O, Rissanen A, Hanotin C, Golay A. Efficacy of rimonabant in obese patients with binge eating disorder. Exp Clin Endocrinol Diabetes. 2013 Jan;121(1):20-6. doi: 10.1055/s-0032-1329957. Epub 2012 Nov 12.