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CompletedNCT02364947Updated Sep 30, 2019Results posted

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 interventional study of Nalmefene hydrochloride and Placebo in Alcohol Dependence, sponsored by Otsuka Pharmaceutical Co., Ltd.. Completed at 7 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Otsuka Pharmaceutical Co., Ltd. (part of Otsuka Holdings Co., Ltd.) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
678
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.

02

Conditions studied

  • Alcohol Dependence

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03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 678 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Otsuka Pharmaceutical Co., Ltd. is the lead sponsor of 143 studies on the registry; 11 are open to participants now.

Browse Otsuka Pharmaceutical Co., Ltd. studies →All Otsuka Holdings Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
678 participants (actual)

Study arms

  • Experimental
    Nalmefene hydrochloride 10 mg

    Drug: Nalmefene hydrochloride

  • Experimental
    Nalmefene hydrochloride 20 mg

    Drug: Nalmefene hydrochloride

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  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

    Time frame: Week 12

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

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

    Time frame: 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

    Time frame: Week 24

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

    Proportion of patients with low or lower drinking risk level

    Time frame: Week 12

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

    Proportion of patients with low or lower drinking risk level

    Time frame: Week 24

  8. 70% TAC Responder Rate at Week 12

    Proportion of patients with a 70% decrease in TAC

    Time frame: Week 12

  9. 70% TAC Responder Rate at Week 24

    Proportion of patients with a 70% decrease in TAC

    Time frame: Week 24

  10. HDD Responder Rate at Week 12

    Proportion of patients with ≤4 HDDs

    Time frame: Week 12

  11. HDD Responder Rate at Week 24

    Proportion of patients with ≤4 HDDs

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: 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).

    Time frame: Week 24

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

    All-patients-randomised set

    Time frame: Week 12

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

    All-patients-randomised set

    Time frame: Week 24

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

    All-patients-randomised set

    Time frame: Week 12

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

    All-patients-randomised set

    Time frame: Week 24

07

Results

Posted Sep 30, 2019

Participant flow

Safety analysis set, which included all randomized patients who received ≥1 dose of the study medication.

Participant flow — Overall Study
MilestoneNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Started248184245
Completed189139219
Not completed594526
Withdrew: Withdrawal by subject1089
Withdrew: Adverse event453311
Withdrew: Protocol violation111
Withdrew: Physician decision325
Withdrew: Death010

Outcome measures

PrimaryChange 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

Time frame:
Week 12
Reported as:
Least squares mean · days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12
days/monthNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12-12.25 ± 0.64-12.09 ± 0.74-7.91 ± 0.61
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = 0.0001 (Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.) · Mean difference (final values): -4.34 · 95% CI -6.05 to -2.62
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.0001 (Efficacy of the doses (change from baseline in the number of HDDs vs placebo) was assessed using a closed testing procedure. The 20 mg dose was tested at a 5% level of significance and only if significant, the testing would proceed to the 10 mg dose.) · Mean difference (final values): -4.18 · 95% CI -6.05 to -2.32
SecondaryChange in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24
Time frame:
Week 24
Reported as:
Least squares mean · days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24
days/monthNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24-13.25 ± 0.66-13.88 ± 0.77-9.33 ± 0.63
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -3.92 · 95% CI -5.69 to -2.16
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -4.54 · 95% CI -6.46 to -2.63
SecondaryChange in Total Alcohol Consumption (TAC) From Baseline at Week 12
Time frame:
Week 12
Reported as:
Least squares mean · g/day
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12
g/dayNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12-44.90 ± 2.01-45.36 ± 2.32-32.43 ± 1.91
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -12.47 · 95% CI -17.81 to -7.13
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -12.94 · 95% CI -18.72 to -7.15
SecondaryChange in Total Alcohol Consumption (TAC) From Baseline at Week 24
Time frame:
Week 24
Reported as:
Least squares mean · g/day
Change in Total Alcohol Consumption (TAC) From Baseline at Week 24
g/dayNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Total Alcohol Consumption (TAC) From Baseline at Week 24-49.43 ± 2.13-49.55 ± 2.45-38.28 ± 1.99
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = 0.0001 · Mean difference (final values): -11.15 · 95% CI -16.77 to -5.53
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.0003 · Mean difference (final values): -11.27 · 95% CI -17.37 to -5.17
SecondaryResponse Shift Drinking Risk Level (RSDRL) at Week 12

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

Time frame:
Week 12
Reported as:
Number · percentage
Response Shift Drinking Risk Level (RSDRL) at Week 12
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Response Shift Drinking Risk Level (RSDRL) at Week 1241.335.720.1
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001 · Risk difference (rd): 22.0 · 95% CI 13.6 to 30.4
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0007 · Risk difference (rd): 15.7 · 95% CI 6.5 to 25.0
SecondaryResponse Shift Drinking Risk Level (RSDRL) at Week 24

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

Time frame:
Week 24
Reported as:
Number · percentage
Response Shift Drinking Risk Level (RSDRL) at Week 24
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Response Shift Drinking Risk Level (RSDRL) at Week 2444.447.527.5
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0002 · Risk difference (rd): 18.0 · 95% CI 8.8 to 27.2
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001 · Risk difference (rd): 20.6 · 95% CI 10.4 to 30.8
SecondaryResponse Low Drinking Risk Level (RLDRL) at Week 12

Proportion of patients with low or lower drinking risk level

Time frame:
Week 12
Reported as:
Number · percentage
Response Low Drinking Risk Level (RLDRL) at Week 12
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Response Low Drinking Risk Level (RLDRL) at Week 1229.625.310.7
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = <0.0001 · Risk difference (rd): 17.8 · 95% CI 10.5 to 25.1
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0002 · Risk difference (rd): 14.3 · 95% CI 6.4 to 22.2
SecondaryResponse Low Drinking Risk Level (RLDRL) at Week 24

Proportion of patients with low or lower drinking risk level

Time frame:
Week 24
Reported as:
Number · percentage
Response Low Drinking Risk Level (RLDRL) at Week 24
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Response Low Drinking Risk Level (RLDRL) at Week 2429.632.617.6
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0079 · Risk difference (rd): 11.0 · 95% CI 2.9 to 19.1
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0010 · Risk difference (rd): 14.8 · 95% CI 5.8 to 23.9
Secondary70% TAC Responder Rate at Week 12

Proportion of patients with a 70% decrease in TAC

Time frame:
Week 12
Reported as:
Number · percentage
70% TAC Responder Rate at Week 12
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
70% TAC Responder Rate at Week 1218.019.58.5
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0022 · Risk difference (rd): 9.9 · 95% CI 3.5 to 16.3
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0016 · Risk difference (rd): 11.1 · 95% CI 3.8 to 18.3
Secondary70% TAC Responder Rate at Week 24

Proportion of patients with a 70% decrease in TAC

Time frame:
Week 24
Reported as:
Number · percentage
70% TAC Responder Rate at Week 24
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
70% TAC Responder Rate at Week 2423.823.410.8
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0003 · Risk difference (rd): 13.6 · 95% CI 6.2 to 20.9
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0013 · Risk difference (rd): 12.8 · 95% CI 4.6 to 21.0
SecondaryHDD Responder Rate at Week 12

Proportion of patients with ≤4 HDDs

Time frame:
Week 12
Reported as:
Number · percentage
HDD Responder Rate at Week 12
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
HDD Responder Rate at Week 1235.036.419.2
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0002 · Risk difference (rd): 15.2 · 95% CI 7.1 to 23.3
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001 · Risk difference (rd): 17.9 · 95% CI 8.9 to 26.9
SecondaryHDD Responder Rate at Week 24

Proportion of patients with ≤4 HDDs

Time frame:
Week 24
Reported as:
Number · percentage
HDD Responder Rate at Week 24
percentageNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
HDD Responder Rate at Week 2433.944.025.2
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0724 · Risk difference (rd): 8.0 · 95% CI -0.7 to 16.7
  • Nalmefene Hydrochloride 10 mg vs Placebo · Cochran-Mantel-Haenszel · p = 0.0001 · Risk difference (rd): 19.6 · 95% CI 9.9 to 29.2
SecondaryChange 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).

Time frame:
Week 12
Reported as:
Least squares mean · units on a scale
Change in CGI-S From Baseline at Week 12
units on a scaleNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in CGI-S From Baseline at Week 12-0.60 ± 0.05-0.63 ± 0.06-0.34 ± 0.05
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = 0.0002 · Mean difference (final values): -0.27 · 95% CI -0.40 to -0.13
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.0001 · Mean difference (final values): -0.30 · 95% CI -0.45 to -0.15
SecondaryChange 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).

Time frame:
Week 24
Reported as:
Least squares mean · units on a scale
Change in CGI-S From Baseline at Week 24
units on a scaleNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in CGI-S From Baseline at Week 24-0.75 ± 0.06-0.77 ± 0.07-0.41 ± 0.05
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.33 · 95% CI -0.48 to -0.18
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.35 · 95% CI -0.51 to -0.19
SecondaryChange 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).

Time frame:
Week 12
Reported as:
Least squares mean · units on a scale
Change in CGI-I From Baseline at Week 12
units on a scaleNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in CGI-I From Baseline at Week 122.62 ± 0.072.65 ± 0.083.13 ± 0.06
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.51 · 95% CI -0.69 to -0.33
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.47 · 95% CI -0.67 to -0.27
SecondaryChange 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).

Time frame:
Week 24
Reported as:
Least squares mean · units on a scale
Change in CGI-I From Baseline at Week 24
units on a scaleNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in CGI-I From Baseline at Week 242.49 ± 0.072.44 ± 0.092.99 ± 0.07
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.51 · 95% CI -0.70 to -0.31
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.55 · 95% CI -0.77 to -0.33
SecondaryChange in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12

All-patients-randomised set

Time frame:
Week 12
Reported as:
Least squares mean · IU/L
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12
IU/LNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 123.666 ± 0.0273.702 ± 0.0313.858 ± 0.025
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.192 · 95% CI -0.262 to -0.121
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.0001 · Mean difference (final values): -0.156 · 95% CI -0.232 to -0.080
SecondaryChange in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24

All-patients-randomised set

Time frame:
Week 24
Reported as:
Least squares mean · IU/L
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24
IU/LNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 243.663 ± 0.0313.692 ± 0.0353.831 ± 0.028
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -0.168 · 95% CI -0.248 to -0.088
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.0017 · Mean difference (final values): -0.139 · 95% CI -0.226 to -0.052
SecondaryChange in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12

All-patients-randomised set

Time frame:
Week 12
Reported as:
Least squares mean · IU/L
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12
IU/LNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 122.968 ± 0.0232.988 ± 0.0273.038 ± 0.021
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = 0.0234 · Mean difference (final values): -0.070 · 95% CI -0.130 to -0.009
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.1374 · Mean difference (final values): -0.049 · 95% CI -0.115 to 0.016
SecondaryChange in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24

All-patients-randomised set

Time frame:
Week 24
Reported as:
Least squares mean · IU/L
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24
IU/LNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 242.971 ± 0.0232.987 ± 0.0273.036 ± 0.021
Statistical analysis
  • Nalmefene Hydrochloride 20 mg vs Placebo · Mixed Models Analysis · p = 0.0348 · Mean difference (final values): -0.066 · 95% CI -0.127 to -0.005
  • Nalmefene Hydrochloride 10 mg vs Placebo · Mixed Models Analysis · p = 0.1444 · Mean difference (final values): -0.049 · 95% CI -0.116 to 0.017

Adverse events

Collected over 24-week treatment period. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Nalmefene Hydrochloride 20 mg0/248 (0%)2/248 (0.8%)175/248 (70.6%)
Nalmefene Hydrochloride 10 mg1/184 (0.5%)2/184 (1.1%)125/184 (67.9%)
Placebo0/245 (0%)2/245 (0.8%)127/245 (51.8%)
Most frequent serious events
Most frequent serious events
EventNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
Femur fractureInjury, poisoning and procedural complications0/2481/1840/245
Spinal compression fractureInjury, poisoning and procedural complications0/2481/1840/245
Anastomotic ulcer haemorrhageInjury, poisoning and procedural complications0/2480/1841/245
AlcoholismPsychiatric disorders0/2480/1841/245
Chronic hepatitisHepatobiliary disorders1/2480/1840/245
GastroenteritisInfections and infestations1/2480/1840/245
Most frequent other events
Showing 10 of 11
Most frequent other events
EventNalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlacebo
NasopharyngitisInfections and infestations54/24840/18491/245
NauseaGastrointestinal disorders79/24858/18415/245
DizzinessNervous system disorders51/24820/18410/245
SomnolenceNervous system disorders39/24818/18417/245
VomitingGastrointestinal disorders34/24816/1845/245
HeadacheNervous system disorders24/24821/18420/245
MalaiseGeneral disorders24/2487/1848/245
InsomniaPsychiatric disorders20/24815/1842/245
Decreased appetiteMetabolism and nutrition disorders13/24811/1843/245
PalpitationsCardiac disorders13/2487/1842/245

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
<=18 years0000
Between 18 and 65 years213159217589
>=65 years29212777
Age, Continuous
Age, Continuous(years)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Mean48.9 ± 12.249.2 ± 11.948.1 ± 11.448.7 ± 11.8
Sex: Female, Male
Sex: Female, Male(Participants)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Female724690208
Male170134154458
Region of Enrollment
Region of Enrollment(participants)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Japan242180244666
Heavy Drinking Days (HDDs)
Heavy Drinking Days (HDDs)(days/month)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Mean22.64 ± 6.3723.49 ± 6.0722.97 ± 6.4422.99 ± 6.32
Total Alcohol Consumption (TAC)
Total Alcohol Consumption (TAC)(g/day)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Mean93.07 ± 37.4595.93 ± 41.1095.08 ± 48.7094.58 ± 42.79
Drinking Risk Level (DRL)
Drinking Risk Level (DRL)(Participants)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Low0000
Medium0011
High13593127355
Very high10787116310
Clinical Global Impression - Severity of Illness (CGI-S) score
Clinical Global Impression - Severity of Illness (CGI-S) score(units on a scale)Nalmefene Hydrochloride 20 mgNalmefene Hydrochloride 10 mgPlaceboTotal
Mean3.38 ± 1.063.48 ± 1.153.45 ± 1.093.43 ± 1.09

2 further baseline measures are reported on the registry.

08

Study locations

7 sites
  • Chubu
    Region, Japan
  • Hokkaido
    Region, Japan
  • Kanto
    Region, Japan
  • Kinki
    Region, Japan
  • Kyusyu
    Region, Japan
  • Tohoku
    Region, Japan
  • Tyugoku
    Region, Japan
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02364947
Lead sponsor
Otsuka Pharmaceutical Co., Ltd.
Collaborators
H. Lundbeck A/S
Responsible party
Sponsor
First posted
Feb 18, 2015
Start date
Feb 9, 2015
Primary completion
Jul 30, 2016
Completion
Jul 30, 2016
Results posted
Sep 30, 2019
Last update
Sep 30, 2019

Study contacts

Osamu Sato
study director · Otsuka Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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