drugset

drugset / Trial / NCT00811941

Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT00811941 ↗

Phase 3 Completed 665 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with alcohol dependence.

Timeline

Start: 2009-03
Primary completion: 2010-11
Completion: 2010-11

Outcome

Missed primary endpoint

registry Placebo vs Nalmefene 18.06 mg; p = 0.160; Mean Difference (Final Values) -0.88 (95% CI -2.10 to 0.35) NCT00811941 ↗

registry Placebo vs Nalmefene 18.06 mg; p = 0.232; Mean Difference (Final Values) -3.47 (95% CI -9.17 to 2.23) NCT00811941 ↗

Publications

Laramee P, Brodtkorb TH, Rahhali N, Knight C, Barbosa C, Francois C, Toumi M, Daeppen JB, Rehm J. The cost-effectiveness and public health benefit of nalmefene added to psychosocial support for the reduction of alcohol consumption in alcohol-dependent patients with high/very high drinking risk levels: a Markov model. BMJ Open. 2014 Sep 16;4(9):e005376. doi: 10.1136/bmjopen-2014-005376.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Nalmefene	Small molecule	18.06 mg	Oral

Indications