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Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence

NCT00811941 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 665

Last updated 2013-08-07

Study results available
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Summary

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

Conditions

  • Alcohol Dependence

Interventions

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.

Sponsors & Collaborators

  • H. Lundbeck A/S

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Czechia
  • Estonia
  • Hungary
  • Latvia
  • Lithuania
  • Poland
  • Russia
  • Slovakia
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00811941 on ClinicalTrials.gov