At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 598 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Nalmefene 18.06 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.
Nalmefene Efficacy Study I: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, As-needed Use, in Patients With Alcohol Dependence
In Brief
A Phase 3 clinical trial evaluating Placebo and Nalmefene for Alcohol Dependence. Completed, enrolled 598 participants across 39 sites in 4 countries.
Detailed Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesAustria, Finland, Germany, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2008
First PostedDec 2008
Primary CompletionOct 2010
Study CompletionNov 2010
TodayJul 2026
First PostedDec 19, 2008
Enrollment StartDec 1, 2008
Primary CompletionOct 1, 2010
Study CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.5 years ago
Interventions
Placebodrug
as-needed use, tablets, orally, 6 months
Nalmefenedrug
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.