A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder

Obesity Clinical Trial

Official title:

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00402584
• Other study ID #: SB237
• Status: Completed
• Phase: Phase 3
• First received: November 20, 2006
• Last updated: August 30, 2007
• Start date: August 2000

Study information

• Verified date: August 2007
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the safety and efficacy of sibutramine in preventing binge eating episodes. Additionally the study aim is to evaluate the safety and efficacy of sibutramine in reducing body weight in subjects with binge-eating disorder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Participants were men and women

• between the ages of 18 and 65

• with Body Mass Index (BMI) <45 kg/m2

• who met DSM-IV criteria for BED

Exclusion Criteria:

• Participants were excluded

• for blood pressure >140/90 mm Hg

• with pulse >95 beats/min

• history of stroke, narrow angle glaucoma, cardiac disease, seizures, renal or hepatic dysfunction

• use of insulin, medications known to affect body weight, or certain psychoactive medications (monoamine oxidase inhibitors, lithium, SSRIs, opioids)

• current participation in a weight loss program

• surgical treatment for obesity

• bulimia nervosa or purging in the past 6 months

• alcohol or drug abuse in the past 12 months

• current psychiatric condition being treated with a psychoactive agent

• current major depressive disorder

• history of anorexia nervosa, psychosis, bipolar disorder, or suicide attempts

• psychotherapy within the previous 2 months

• Women were excluded if they were pregnant, lactating, or if fertile, not practicing adequate contraceptive precautions

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Obesity

Intervention

Drug:
• sibutramine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals		6 months
Secondary	Change from baseline in frequency of binge days (or mean days per week when the participant had one or more binges)		6 months
Secondary	Change from baseline in Body Weight		6 months
Secondary	Change from baseline in BMI		6 months
Secondary	Change from baseline in global improvement		6 months
Secondary	Change from baseline in eating pathology (TFEQ)		6 months
Secondary	Change from baseline in quality of life (IWQOL-Lite).		6 months