CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 436 enrolled
Drug / intervention
Medisorb naltrexone 380 mg +1 moredrug
Likely dose
Medisorb naltrexone 380 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/NCT01218997
NCT01218997Phase 3Completed
CompareCT.gov

A Randomized, Open Label, Long-Term, Multi-Center Study of the Safety of Medisorb® Naltrexone

Alkermes, Inc.·interventional·Posted Oct 13, 2010·Updated Jan 4, 2011

In Brief

A Phase 3 clinical trial evaluating Medisorb naltrexone 380 mg and Oral naltrexone 50 mg for Alcoholism. Completed, enrolled 436 participants.

Detailed Summary

This was a Phase 3 multicenter randomized, open-label, safety study assessing the safety of repeat doses of Medisorb® naltrexone 380 mg (VIVITROL®) administered for up to 1 year to adults with alcohol and/or opioid dependence as defined by Diagnostic and Statistical Manual of Mental Health Disorders (DSM-IV) criteria. Eligible subjects were randomized in a 6:1 ratio to receive 1 of the following regimens: a single intramuscular (IM) injection of VIVITROL administered once every 4 weeks or oral naltrexone 50 mg administered daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcoholism
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2010
Enrollment StartAug 1, 2003
Primary CompletionMar 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 15.7 years ago

Interventions

Medisorb naltrexone 380 mgdrug

Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.

Oral naltrexone 50 mgdrug

Tablet taken orally once daily for up to 1 year