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Completed

NCT Number: NCT02364947

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)

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.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chubu, Region, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 .

Exclusion criteria

  • 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

Treatment and study plan

Nalmefene hydrochloride

Drug

As-needed; tablets, orally

Placebo

Drug

As-needed; tablets, orally

Primary outcomes

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

    Time frame: 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

Secondary outcomes

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

    Time frame: Week 24

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

    Time frame: Week 12

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

    Time frame: Week 24

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

    Time frame: Week 12

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

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

    Time frame: Week 24

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

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

    Time frame: Week 12

    Proportion of patients with low or lower drinking risk level

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

    Time frame: Week 24

    Proportion of patients with low or lower drinking risk level

  8. 70% TAC Responder Rate at Week 12

    Time frame: Week 12

    Proportion of patients with a 70% decrease in TAC

  9. 70% TAC Responder Rate at Week 24

    Time frame: Week 24

    Proportion of patients with a 70% decrease in TAC

  10. HDD Responder Rate at Week 12

    Time frame: Week 12

    Proportion of patients with ≤4 HDDs

  11. HDD Responder Rate at Week 24

    Time frame: Week 24

    Proportion of patients with ≤4 HDDs

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: 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).

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

    Time frame: Week 12

    All-patients-randomised set

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

    Time frame: Week 24

    All-patients-randomised set

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

    Time frame: Week 12

    All-patients-randomised set

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

    Time frame: Week 24

    All-patients-randomised set

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • H. Lundbeck A/S

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 18, 2015
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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