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ALK21-010: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol-dependent Adults

Alcoholism Clinical Trial

Official title:
A Multi-Center Extension of Alkermes' Study ALK21-003-EXT (NCT01218971) to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Clinical Trial Summary

This was a Phase 3, multi-center extension of Alkermes' Study ALK21-003EXT (NCT01218971) to further assess the long-term safety of repeat monthly doses of Medisorb® naltrexone (VIVITROL®).

Clinical Trial Description

Enrolled subjects continued to receive the same dose strength of Medisorb naltrexone (ie, 190 mg or 380 mg) they had received in Study ALK21-003-EXT (NCT01218971). Assigned dose strength (high or low) was not revealed to the subject, the study investigators, or any blinded member of the clinical study team for the duration of the study period. Placebo was not administered. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00156923
Study type Interventional
Source Alkermes, Inc.
Contact
Status Completed
Phase Phase 3
Start date October 2003
Completion date January 2007
View Details
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