Eating Disorders, Obesity
Conditions
Keywords
binge eating, eating disorders, obesity
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.
Interventions
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in body weight from baseline to Day 180 visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: binge eating episodes, BES score, TFEQ dimensions, waist circumference, Body Mass Index | — |
| Safety: clinical examination, vital signs, adverse events, Hospital Anxiety and Depression (HAD) scale | — |
Countries
Finland, France, Netherlands, Portugal, Sweden, Switzerland, United States
Outcome results
None listed