Efficacy and safety of Nalmefene in alcohol-dependent patients with chronic liver disease

Efficacy and safety of Nalmefene in alcohol-dependent patients with chronic liver disease - Efficacy and safety of Nalmefene in alcohol-dependent patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000036655

Enrollment

100

Registered

2019-05-06

Start date

2019-05-10

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 patients

Interventions

Nalmefene is administered once a day for an alcohol dependent patients treated with as-needed 10 mg nalmefene for 24 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with alcohol dependence 2. Patients diagnosed with chronic liver disease 3. Male and female aged 20 years or over at the time of agreement acquisition

Exclusion criteria

Exclusion criteria: 1 Patients with end-stage liver failure who have hepatic ascites, child-Pugh class BC and hepatic encephalopathy 2. Pregnant women or patients with potential pregnancy 3. Patients who research managers judged inappropriate as subjects

Design outcomes

Primary

Measure	Time frame
Change in heavy drinking days (HDDs) after 24 weeks of treatment Primary outcome measures were: changes in heavy drinking days (HDDs) and total alcohol consumption (TAC, g/day).	—

Secondary

Measure	Time frame
1) changes in drinking risk level after 24 weeks of treatment 2) changes in total alcohol consumption after 24 weeks of treatment	—

Countries

Japan

Contacts

Public ContactHaruki Uojima

Kitasato University School of Medicine Department of Gastroenterology, Internal Medicine

kiruha@kitasato-u.ac.jp+81-42-778-8111

Outcome results

None listed

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