NCT00811941

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 665 (actual)
• Sponsor: H. Lundbeck A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with 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 long-term safety and tolerability as well as to evaluate the efficacy of as needed use of 18.06 mg nalmefene in patients with alcohol dependence.

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	Placebo	as-needed use, tablets, orally, 52 weeks
DRUG	Nalmefene	18.06 mg as-needed use, tablets, orally, 52 weeks. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2008-12-19
• Last updated: 2013-08-07
• Results posted: 2013-08-07

Locations

60 sites across 10 countries: Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Russia, Slovakia, Ukraine, United Kingdom