At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 624 enrolled

Drug / intervention

Medisorb naltrexone 190 mg +3 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/NCT01218958

NCT01218958Phase 3Completed

Compare CT.gov

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Medisorb® Naltrexone in Alcohol-Dependent Adults

Alkermes, Inc.·interventional·Posted Oct 13, 2010·Updated Jul 11, 2017

In Brief

A Phase 3 clinical trial evaluating Medisorb naltrexone 190 mg, Medisorb naltrexone 380 mg, and 2 other interventions for Alcoholism. Completed, enrolled 624 participants.

Detailed Summary

This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study conducted in subjects diagnosed with alcohol dependence as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV). Subjects were randomized (2:2:1:1) to receive intramuscular (IM) injections of Medisorb® naltrexone 190 mg, Medisorb naltrexone 380 mg, placebo for Medisorb naltrexone 190 mg, or placebo for Medisorb naltrexone 380 mg (VIVITROL®). Study drug was administered every 4 weeks for a total of 6 injections.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAlcoholism

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartFeb 2002

Primary CompletionSep 2003

First PostedOct 2010

TodayJul 2026

First PostedOct 13, 2010

Enrollment StartFeb 1, 2002

Primary CompletionSep 1, 2003

TodayJul 2, 2026

Enrollment to primary: 1.6 yearsPosted 15.7 years ago

Interventions

Medisorb naltrexone 190 mgdrug

Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.

Medisorb naltrexone 380 mgdrug

IM injection once every 4 weeks for a total of 6 administrations.

Placebo matching Medisorb naltrexone 190 mgdrug

IM injection once every 4 weeks for a total of 6 administrations.

Placebo matching Medisorb naltrexone 380 mgdrug

IM injection once every 4 weeks for a total of 6 administrations.