At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 665 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.
A 52-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Safety, Tolerability and Efficacy Study of 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 665 participants across 60 sites in 10 countries.
Detailed Summary
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Dependence
CountriesCzechia, Estonia, Hungary, Latvia, Lithuania, Poland, Russia, Slovakia, Ukraine, United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 2008
Enrollment StartMar 2009
Primary CompletionNov 2010
TodayJul 2026
First PostedDec 19, 2008
Enrollment StartMar 1, 2009
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.5 years ago
Interventions
Placebodrug
as-needed use, tablets, orally, 52 weeks
Nalmefenedrug
18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.