NCT02824354

Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

Multicentre, Randomised, Double-blind, Placebo-controlled Trial of Nalmefene in Patients With Alcoholic Compensated Cirrhosis for the Treatment of Alcohol Dependence.

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption.

Detailed description

Nalmefene is the first drug to obtain Marketing Authorisation in France for reduction of alcohol consumption. It appears to be significantly more effective in the group of heavy drinkers, while the mean alcohol consumption in studies conducted in cirrhotic patients is greater than 120 g/day. No data are available concerning nalmefene in alcohol-dependent patients with alcoholic cirrhosis. However, nalmefene could represent an attractive alternative to reduce heavy drinking in patients with alcoholic cirrhosis, with potential improvement of liver function. No comparator is available for nalmefene, as all other molecules require abstinence prior to starting treatment.

Conditions

• Cirrhosis
• Alcohol Dependence
• Nalmefene

Interventions

Type	Name	Description
DRUG	Nalmefene (Selincro®) 18 mg tablet	Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.
DRUG	placebo	Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.

Timeline

• Start date: 2018-12-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-07-06
• Last updated: 2023-07-20

Locations

1 site across 1 country: France