Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
NCT ID: NCT04107051
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
533 participants
OBSERVATIONAL
2019-10-01
2024-02-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
NCT02382276
Efficacy of Nalmefene in Patients With Alcohol Dependence
NCT00811720
A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)
NCT02364947
Efficacy of Nalmefene in Patients With Alcohol Dependence
NCT00812461
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
NCT00811941
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nalmefene Hydrochloride Hydrate
Oral administration of nalmefene hydrochloride hydrate
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Patients who are contraindicated
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yasuhiko Fukuta, PhD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Co., Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Otsuka Pharmaceutical Co., Ltd.
Osaka, , Japan
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
339-101-00015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.