Ignite Creation Date:
2024-05-05 @ 10:23 PM
Last Modification Date:
2024-10-26 @ 10:18 AM
Study NCT ID:
NCT01098435
Status:
COMPLETED
Last Update Posted:
2011-08-23
First Post:
2010-04-01
Brief Title:
ALK33-101 A Study of RDC-0313 ALKS 33 in Adults With Binge Eating Disorder
Sponsor:
Alkermes Inc
Organization:
Alkermes Inc
Study Overview
Official Title:
A Phase 2 Randomized Double-Blind Placebo-Controlled Pilot Study of the Safety and Efficacy of RDC-0313 in Adults With Binge Eating Disorder
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety of daily doses of RDC-0313 ALKS 33 compared with placebo in adults with binge-eating disorder BED An additional objective is to explore the efficacy of RDC-0313 treatment in comparison with placebo in adults with binge-eating disorder
Detailed Description:
Following screening eligible subjects will be randomized in a 11 ratio to RDC-0313 ALKS 33 or matching placebo Once-daily at-home dosing will begin at randomization and will continue for 6 weeks There will be 8 study visits over a 12-week study period On an ongoing basis subjects will complete a take-home binge diary designed to record the number of binge-eating episodes binge episodes and binge-eating days binge days days during which at least 1 binge occurred as well as snacks and meals consumed daily over each 7-day period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None