Alcohol DependenceNCT04107051
Post-Marketing Surveillance Study of Nalmefene Hydrochloride Hydrate in Patients with Alcohol Dependence
An observational study of Alcohol Dependence, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alcohol Dependence
- What is being tested?
- Nalmefene Hydrochloride Hydrate
- Type of treatment
- Pill or oral medicine
- How many people
- 533 participants
- Where
- 1 siteJapan
- Study dates
- 1 Oct 2019to 6 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who has ever been treated with nalmefene hydrochloride hydrate
- Patients who are contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)
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.
- Conditions
- Alcohol Dependence
- Being tested
- Nalmefene Hydrochloride Hydrate
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalmefene Hydrochloride HydrateDrug
Oral administration of nalmefene hydrochloride hydrate
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start1 Oct 2019
- Primary completion7 Feb 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol DependenceStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 533 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yasuhiko Fukuta, PhD, Study director, Otsuka Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107051
- Sponsor's protocol ID
- 339-101-00015
- Status last verified
- Feb 2025
- First submitted
- 24 Sep 2019
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nalmefene Hydrochloride Hydrate Tablets 10mg Specified Drug-use Results Survey (the Safety and the Prognosis After Achieving Reduced Alcohol Intake)
- ClinicalTrials.gov ID
- NCT04107051
- Acronym / sponsor ID
- 339-101-00015
- Conditions
- Alcohol Dependence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 533 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 7 Feb 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients who has ever been treated with nalmefene hydrochloride hydrate
- Patients who are contraindicated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nalmefene Hydrochloride HydrateOral administration of nalmefene hydrochloride hydrate | Drug | – |
Primary outcome
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C)
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yasuhiko Fukuta, PhD study director
Otsuka Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Dependence, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Use Disorders Identification Test-Consumption(AUDIT-C) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.