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

July 2, 2020 updated by: Otsuka Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

405

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Region, Japan
        • Kanto
      • Region, Japan
        • Kyusyu
      • Region, Japan
        • Chubu
      • Region, Japan
        • Hokkaido
      • Region, Japan
        • Kinki
      • Region, Japan
        • Tohoku
      • Region, Japan
        • Tyugoku

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nalmefene hydrochloride 20 mg
As-needed; tablets, orally
Drug: Nalmefene hydrochloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Adverse Events
Time Frame: 24-week treatment period
24-week treatment period

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Time Frame: Week 24
Week 24
Change in Total Alcohol Consumption (TAC) From Baseline
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Collaborators

H. Lundbeck A/S

Investigators

  • Study Director: Ono Hiroaki, Mr, Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2015

Primary Completion (Actual)

January 18, 2017

Study Completion (Actual)

January 18, 2017

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2020

Last Update Submitted That Met QC Criteria

July 2, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 339-14-002
  • JapicCTI-152806 (Other Identifier: Japic)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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