drugset / Trial / NCT00501631

ALK21-014: Efficacy and Safety of Medisorb® Naltrexone (VIVITROL®) After Enforced Abstinence

NCT00501631

Phase 3 Completed 300 enrolled Alkermes, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. This Phase 3B trial was designed to evaluate the efficacy and safety of VIVITROL versus placebo. Injections were administered to patients in whom abstinence was enforced by a period of inpatient hospitalization of 7 to 21 days.

Timeline

Start
2007-07
Primary completion
2011-01
Completion
2011-03

Drugs

EvaluationDrugModalityDoseRoute
Comparator Naltrexone Small molecule 380 mg Intramuscular

Indications