At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 678 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 II: 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 678 participants across 57 sites in 7 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
CountriesBelgium, Czechia, France, Italy, Poland, Portugal, Spain
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartMar 2009
Primary CompletionMar 2011
Study CompletionApr 2011
TodayJul 2026
First PostedDec 22, 2008
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2011
Study CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2 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.