NCT00812461

Efficacy of Nalmefene in Patients With Alcohol Dependence

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 678 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Detailed description

Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Placebo	as-needed use, tablets, orally, 6 months
DRUG	Nalmefene	18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2008-12-22
• Last updated: 2013-07-22
• Results posted: 2013-07-09

Locations

57 sites across 7 countries: Belgium, Czechia, France, Italy, Poland, Portugal, Spain