A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
2 other identifiers
interventional
405
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2015
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2015
CompletedFirst Posted
Study publicly available on registry
March 6, 2015
CompletedStudy Start
First participant enrolled
July 13, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2017
CompletedResults Posted
Study results publicly available
July 20, 2020
CompletedJuly 20, 2020
July 1, 2020
1.5 years
February 10, 2015
July 2, 2020
July 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events
24-week treatment period
Secondary Outcomes (2)
Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Week 24
Change in Total Alcohol Consumption (TAC) From Baseline
Week 24
Study Arms (1)
Nalmefene hydrochloride 20 mg
EXPERIMENTALAs-needed; tablets, orally
Interventions
Eligibility Criteria
You may qualify if:
- Patients who have completed Study 339-14-001
- Patients who have signed the informed consent form for Study 339-14-002
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Otsuka Pharmaceutical Co., Ltd.lead
- H. Lundbeck A/Scollaborator
Study Sites (7)
Chubu
Region, Japan
Hokkaido
Region, Japan
Kanto
Region, Japan
Kinki
Region, Japan
Kyusyu
Region, Japan
Tohoku
Region, Japan
Tyugoku
Region, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Otsuka Pharmaceutical Co., LTD.
Study Officials
- STUDY DIRECTOR
Ono Hiroaki, Mr
Otsuka Pharmaceutical Co., Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2015
First Posted
March 6, 2015
Study Start
July 13, 2015
Primary Completion
January 18, 2017
Study Completion
January 18, 2017
Last Updated
July 20, 2020
Results First Posted
July 20, 2020
Record last verified: 2020-07