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Alcohol DependencePhase 3NCT02364947

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)

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 efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative 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?
Yes, some participants may receive a placebo
How many people
678 participants
Where
7 sitesJapan
Study dates
9 Feb 2015to 30 Jul 2016
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

  • Japanese males and females aged 20 or above who have signed the informed consent form
  • The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.)
  • The patient has a drinking risk level of High or above (> 60 g for men and > 40 g for women) both at the Screening Visit and at the Randomization Visit .

Who cannot join

  • The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I.
  • The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test

Trial locations and contacts

7 sites in 1 country.

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 efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

Being tested
Nalmefene hydrochloride, Placebo
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

    As-needed; tablets, orally

  • PlaceboDrug

    As-needed; tablets, orally

Study groups in NCT02364947
Study groupRoleWhat they receive
Nalmefene hydrochloride 10 mgExperimentalNot described
Receives: Drug: Nalmefene hydrochloride
Nalmefene hydrochloride 20 mgExperimentalNot described
Receives: Drug: Nalmefene hydrochloride
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12

    The number of HDDs is defined as the number of days per month [days/month] with alcohol consumption of > 60 g for males and > 40 g for females

    Measured: Week 12

Secondary outcomes (19)

  1. Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24

    Measured: Week 24

  2. Change in Total Alcohol Consumption (TAC) From Baseline at Week 12

    Measured: Week 12

  3. Change in Total Alcohol Consumption (TAC) From Baseline at Week 24

    Measured: Week 24

  4. Response Shift Drinking Risk Level (RSDRL) at Week 12

    Proportion of patients with a downward shift in drinking risk level of two categories or more

    Measured: Week 12

  5. Response Shift Drinking Risk Level (RSDRL) at Week 24

    Proportion of patients with a downward shift in drinking risk level of two categories or more

    Measured: Week 24

  6. Response Low Drinking Risk Level (RLDRL) at Week 12

    Proportion of patients with low or lower drinking risk level

    Measured: Week 12

  7. Response Low Drinking Risk Level (RLDRL) at Week 24

    Proportion of patients with low or lower drinking risk level

    Measured: Week 24

  8. 70% TAC Responder Rate at Week 12

    Proportion of patients with a 70% decrease in TAC

    Measured: Week 12

  9. 70% TAC Responder Rate at Week 24

    Proportion of patients with a 70% decrease in TAC

    Measured: Week 24

  10. HDD Responder Rate at Week 12

    Proportion of patients with ≤4 HDDs

    Measured: Week 12

  11. HDD Responder Rate at Week 24

    Proportion of patients with ≤4 HDDs

    Measured: Week 24

  12. Change in CGI-S From Baseline at Week 12

    The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).

    Measured: Week 12

  13. Change in CGI-S From Baseline at Week 24

    The CGI-S scale was used by clinicians when assessing their global impression of a patient's current clinical condition. The investigator or subinvestigator used his/her clinical experience with this patient population to rate the severity of a subject's clinical condition on a 7-point scale ranging from 1 (Normal, not at all ill) to 7 (Among the most extremely ill patients).

    Measured: Week 24

  14. Change in CGI-I From Baseline at Week 12

    The CGI-I scale is used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

    Measured: Week 12

  15. Change in CGI-I From Baseline at Week 24

    The CGI-I scale was used to assess a patient's improvement (or worsening). The investigator or subinvestigator assesses a subject's condition relative to baseline on a 7-point scale ranging from 1 (Very much improved) to 7 (Very much worse).

    Measured: Week 24

  16. Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12

    All-patients-randomised set

    Measured: Week 12

  17. Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24

    All-patients-randomised set

    Measured: Week 24

  18. Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12

    All-patients-randomised set

    Measured: Week 12

  19. Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24

    All-patients-randomised set

    Measured: Week 24

Timeline

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

  1. First posted18 Feb 2015 (estimated)
  2. Study start9 Feb 2015
  3. Primary completion30 Jul 2016
  4. Study completion30 Jul 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
678 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02364947
Sponsor's protocol ID
339-14-001
Other IDs
JapicCTI-152804
Status last verified
Jul 2019
First submitted
10 Feb 2015
Last updated
30 Sep 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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 3 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 30 Sep 2019. 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. Some participants in this study may receive a placebo. 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 30 Sep 2019). 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?

Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12 (time frame: Week 12). 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 NCT02364947.

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 30 Sep 2019.

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