CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 332 enrolled
Drug / intervention
Medisorb naltrexone 190 mg +1 moredrug
Likely dose
Medisorb naltrexone 190 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01218971
NCT01218971Phase 3Completed
CompareCT.gov

A Multicenter Double-Blind Extension of Alkermes Study ALK21-003 to Evaluate the Long-Term Safety of Medisorb® Naltrexone

Alkermes, Inc.·interventional·Posted Oct 13, 2010·Updated Dec 24, 2010

In Brief

A Phase 3 clinical trial evaluating Medisorb naltrexone 190 mg and Medisorb naltrexone 380 mg for Alcohol Dependence. Completed, enrolled 332 participants.

Detailed Summary

This was a Phase 3 multicenter extension of Alkermes' Study ALK21-003 (NCT01218958 \[the base study\]) that evaluated the safety of Medisorb® naltrexone (VIVITROL®) administered every 4 weeks for 48 weeks (13 injections) in alcohol-dependent adults who had completed Study ALK21-003.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2010
Enrollment StartAug 1, 2002
Primary CompletionSep 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 15.7 years ago

Interventions

Medisorb naltrexone 190 mgdrug

naltrexone for extended-release injectable suspension

Medisorb naltrexone 380 mgdrug

naltrexone for extended-release injectable suspension