Alcohol DependencePhase 3NCT02382276

A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

A Phase 3 study testing Nalmefene hydrochloride in people with Alcohol Dependence, run by Otsuka Pharmaceutical Co., Ltd. at 7 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Alcohol Dependence
What is being tested?: Nalmefene hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: 7 sitesJapan
Study dates: 13 Jul 2015to 18 Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients who have completed Study 339-14-001
Patients who have signed the informed consent form for Study 339-14-002

Who cannot join

The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Japan7 sites

Chubu
Region
Hokkaido
Region
Kanto
Region
Kinki
Region
Kyusyu
Region
Tohoku
Region
Tyugoku
Region

Other trials in Japan

About this study

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Conditions: Alcohol Dependence
Being tested: Nalmefene hydrochloride
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nalmefene hydrochlorideDrug

Study groups in NCT02382276
Study group	Role	What they receive
Nalmefene hydrochloride 20 mg	Experimental	As-needed; tablets, orally Receives: Drug: Nalmefene hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Measured: 24-week treatment period

Secondary outcomes (2)

Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Measured: Week 24
Change in Total Alcohol Consumption (TAC) From Baseline
Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 201518 Jan 2017

First posted6 Mar 2015 (estimated)
Study start13 Jul 2015
Primary completion18 Jan 2017
Study completion18 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alcohol DependenceStudies of the same condition, open and under way.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02382276
Sponsor's protocol ID: 339-14-002
Other IDs: JapicCTI-152806
Status last verified: Jul 2020
First submitted: 10 Feb 2015
Last updated: 20 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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SMART-r: Substance Monitoring and Active Relapse Tracking Repository
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Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
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All Alcohol Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
ClinicalTrials.gov ID: NCT02382276
Acronym / sponsor ID: 339-14-002
Conditions: Alcohol Dependence
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: H. Lundbeck A/S
Study start: 13 Jul 2015 (actual)
Primary completion: 18 Jan 2017 (actual)
Study completion: 18 Jan 2017 (actual)
First posted: 6 Mar 2015 (estimated)
Results: Posted 20 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nalmefene hydrochloride 20 mg	Experimental	Drug: Nalmefene hydrochlorideAs-needed; tablets, orally

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients who have completed Study 339-14-001
Patients who have signed the informed consent form for Study 339-14-002

Key exclusion criteria (2 listed)

The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 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

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	Drug	Nalmefene hydrochloride 20 mg

Primary outcome

Number of Participants With Adverse Events
Time frame: 24-week treatment period

2 secondary outcomes

Change in the Number of Heavy Drinking Days (HDDs) From Baseline
Time frame: Week 24
Change in Total Alcohol Consumption (TAC) From Baseline
Time frame: Week 24

Results and safety

Results posted to the registry on 20 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nalmefene 20 mg in the lead-in Study	137	126
Nalmefene 10 mg in the lead-in Study	94	84
Placebo in the lead-in Study	172	133

Primary outcome: Number of Participants With Adverse Events

Time frame: 24-week treatment period. Number. Unit: Number of participants

Measure	Nalmefene 20 mg in the lead-in Study n = 137	Nalmefene 10 mg in the lead-in Study n = 94	Placebo in the lead-in Study n = 172
Value	96	67	141

Population analysed: Safety analysis set, which included all patients who received at least one dose of study medication during the 24-week treatment period in the extension study.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 24-week treatment period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Total	3 of 403 (0.7%)	209 of 403 (51.9%)	0 of 403

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Alcohol Dependence

RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
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Recruiting
Peer Support for Liver Transplant Recipients With History of ALD
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Recruiting
Safety and Effectiveness of the BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) for Treatment and Reduction of Heavy Drinking in Individuals With of Alcohol Use Disorder (AUD)
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RecruitingPhase 1
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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.

Ono Hiroaki, Mr study director

Otsuka Pharmaceutical Co., Ltd.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nalmefene hydrochloride in people with Alcohol Dependence, run by Otsuka Pharmaceutical Co., Ltd. at 7 sites 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 2 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 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Adverse Events (time frame: 24-week treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02382276.

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 20 Jul 2020.