A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder
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ClinicalTrials.gov Identifier: NCT00402584 |
Recruitment Status
:
Completed
First Posted
: November 22, 2006
Last Update Posted
: August 31, 2007
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Sponsor:
Abbott
Information provided by:
Abbott
Tracking Information | ||||
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First Submitted Date ICMJE | November 20, 2006 | |||
First Posted Date ICMJE | November 22, 2006 | |||
Last Update Posted Date | August 31, 2007 | |||
Study Start Date ICMJE | August 2000 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals [ Time Frame: 6 months ] | |||
Original Primary Outcome Measures ICMJE |
The frequency of binge eating episodes (binges/week), defined as the mean number of binges per week in 2-week intervals | |||
Change History | Complete list of historical versions of study NCT00402584 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | A Study to Examine the Efficacy and Safety of Meridia® (Sibutramine Hydrochloride) in Binge-Eating Disorder | |||
Official Title ICMJE | A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Study to Examine the Efficacy and Safety of Meridia (Sibutramine Hydrochloride) in Binge-Eating Disorder | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: sibutramine | |||
Study Arms | Not Provided | |||
Publications * | Wilfley DE, Crow SJ, Hudson JI, Mitchell JE, Berkowitz RI, Blakesley V, Walsh BT; Sibutramine Binge Eating Disorder Research Group. Efficacy of sibutramine for the treatment of binge eating disorder: a randomized multicenter placebo-controlled double-blind study. Am J Psychiatry. 2008 Jan;165(1):51-8. Epub 2007 Dec 3. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
304 | |||
Original Enrollment ICMJE |
300 | |||
Study Completion Date | Not Provided | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00402584 | |||
Other Study ID Numbers ICMJE | SB237 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Abbott | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Abbott | |||
Verification Date | August 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |