ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
|Alcoholism||Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone 50 mg||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone|
- Number of Subjects Reporting at Least 1 Treatment-emergent Adverse Event (TEAE) While on Study [ Time Frame: up to 1 year ]A TEAE was defined as any adverse event (AE) that started or worsened on or after the administration of the first dose of study medication through 30 days after the end of study treatment.
|Study Start Date:||August 2003|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
|Experimental: Medisorb naltrexone 380 mg (VIVITROL)||
Drug: Medisorb naltrexone 380 mg
Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
|Active Comparator: Oral naltrexone 50 mg||
Drug: Oral naltrexone 50 mg
Tablet taken orally once daily for up to 1 year
Other Name: Revia®
Safety evaluations included physical examinations, electrocardiograms (ECGs), laboratory measures (including plasma concentrations of naltrexone and 6β-naltrexol), assessments of injection sites, and adverse events (AEs).
All subjects received psychosocial support at each study visit for the duration of the study, with interim telephone contact 2 weeks after each monthly visit.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218997
|Study Director:||Bernard L. Silverman, MD||Alkermes, Inc.|