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CompletedNCT04107051Updated Mar 21, 2025

Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence

An observational study in Alcohol Dependence, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2025-03-21.

Sponsored by Otsuka Pharmaceutical Co., Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
533
Sex
All
01

Study summary

The purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in Japan.

02

Conditions studied

  • Alcohol Dependence

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03

In context

Alcoholism

1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 533 is above the median of 180 across 173 observational studies indexed under Alcoholism.

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Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 140 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with alcohol dependence who are planned to be newly started on nalmefene hydrochloride hydrate for the treatment of reduction of alcohol consumption.

Inclusion criteria

  • Clinical diagnosis of Alcohol Dependence
  • Must agree to follow-up during the first year of prescription and publication of survey results
  • Patients whose goal of treatment for Alcohol Dependence is to reduce alcohol consumption
  • Patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption
  • Patients who have chronic heavy drinking
  • Patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption

Exclusion criteria

Exclusion Criteria:

  • Patients who has ever been treated with nalmefene hydrochloride hydrate
  • Patients who are contraindicated
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
533 participants (actual)
Patient registry
No

Interventions

  • DrugNalmefene Hydrochloride Hydrate

    Oral administration of nalmefene hydrochloride hydrate

06

What researchers measure

Primary outcomes

  1. Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)

    Time frame: 1 year

07

Study locations

1 site
  • Otsuka Pharmaceutical Co., Ltd.
    Osaka, Japan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04107051
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Sep 27, 2019
Start date
Oct 1, 2019
Primary completion
Feb 7, 2023
Completion
Feb 6, 2024
Last update
Mar 21, 2025

Study contacts

Yasuhiko Fukuta, PhD
study director · Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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