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

Primary Purpose

Alcohol Dependence

Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Nalmefene hydrochloride
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcohol Dependence

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chubu
  • Hokkaido
  • Kanto
  • Kinki
  • Kyusyu
  • Tohoku
  • Tyugoku

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nalmefene hydrochloride 20 mg

Arm Description

As-needed; tablets, orally

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events

Secondary Outcome Measures

Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Change in Total Alcohol Consumption (TAC) From Baseline

Full Information

First Posted
February 10, 2015
Last Updated
July 2, 2020
Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02382276
Brief Title
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Official Title
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
July 13, 2015 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
January 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nalmefene hydrochloride 20 mg
Arm Type
Experimental
Arm Description
As-needed; tablets, orally
Intervention Type
Drug
Intervention Name(s)
Nalmefene hydrochloride
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
24-week treatment period
Secondary Outcome Measure Information:
Title
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Time Frame
Week 24
Title
Change in Total Alcohol Consumption (TAC) From Baseline
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ono Hiroaki, Mr
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Chubu
City
Region
Country
Japan
Facility Name
Hokkaido
City
Region
Country
Japan
Facility Name
Kanto
City
Region
Country
Japan
Facility Name
Kinki
City
Region
Country
Japan
Facility Name
Kyusyu
City
Region
Country
Japan
Facility Name
Tohoku
City
Region
Country
Japan
Facility Name
Tyugoku
City
Region
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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