ALK21-006: Long-Term Study of Medisorb® Naltrexone (VIVITROL®)
|ClinicalTrials.gov Identifier: NCT01218997|
Recruitment Status : Completed
First Posted : October 13, 2010
Results First Posted : December 13, 2010
Last Update Posted : January 4, 2011
|Condition or disease||Intervention/treatment||Phase|
|Alcoholism||Drug: Medisorb naltrexone 380 mg Drug: Oral naltrexone 50 mg||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||436 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone|
|Study Start Date :||August 2003|
|Primary Completion Date :||March 2005|
|Study Completion Date :||March 2005|
|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®
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218997
|Study Director:||Bernard L. Silverman, MD||Alkermes, Inc.|