Skip to main content
OpenTrials
Completed

NCT Number: NCT02382276

A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu, Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have completed Study 339-14-001
  • Patients who have signed the informed consent form for Study 339-14-002

Exclusion criteria

  • The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)
  • The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator

Treatment and study plan

Nalmefene hydrochloride

Drug

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: 24-week treatment period

Secondary outcomes

  1. Change in the Number of Heavy Drinking Days (HDDs) From Baseline

    Time frame: Week 24

  2. Change in Total Alcohol Consumption (TAC) From Baseline

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • H. Lundbeck A/S

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 6, 2015
Registry last updated
Jul 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.