A long-term extension study for the phase 3 study of nalmefene (339-14-001) in patients with alcohol dependence

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222754

Enrollment

400

Registered

2015-02-12

Start date

2015-07-13

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol dependent

Interventions

investigational material(s) Generic name etc : Nalmefene hydrochloride INN of investigational material : Nalmefene Hydrochloride Hydrate Therapeutic category code : 119 Other agents affecting central

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: - The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class 3 or 4 heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of under 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.

Design outcomes

Primary

Measure	Time frame
safety Adverse Events, Laboratory Parameters and Vital Signs	—

Secondary

Measure	Time frame
efficacy The number of Heavy Drinking Days (HDDs) Change in the number of HDDs from baseline	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026