Trial · 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)

NCT02364947, Phase 3, Completed, Otsuka Pharmaceutical Co., Ltd.; results first posted 2019-09-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT02364947. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02364947

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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)
NCT number: NCT02364947
Status: Completed
Phases: Phase 3
Enrollment: 678 participants, actual
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Conditions: Alcohol Dependence
Interventions: Nalmefene hydrochloride, Placebo
First posted: 2015-02-18
Last updated: 2019-09-30
Results first posted: 2019-09-30

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12	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	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24	Week 24
Secondary	Change in Total Alcohol Consumption (TAC) From Baseline at Week 12	Week 12
Secondary	Change in Total Alcohol Consumption (TAC) From Baseline at Week 24	Week 24
Secondary	Response Shift Drinking Risk Level (RSDRL) at Week 12	Week 12	Proportion of patients with a downward shift in drinking risk level of two categories or more
Secondary	Response Shift Drinking Risk Level (RSDRL) at Week 24	Week 24	Proportion of patients with a downward shift in drinking risk level of two categories or more
Secondary	Response Low Drinking Risk Level (RLDRL) at Week 12	Week 12	Proportion of patients with low or lower drinking risk level
Secondary	Response Low Drinking Risk Level (RLDRL) at Week 24	Week 24	Proportion of patients with low or lower drinking risk level
Secondary	70% TAC Responder Rate at Week 12	Week 12	Proportion of patients with a 70% decrease in TAC
Secondary	70% TAC Responder Rate at Week 24	Week 24	Proportion of patients with a 70% decrease in TAC

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12	Week 12	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	days/month	LEAST_SQUARES_MEAN
SECONDARY	Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24	Week 24	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	days/month	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Alcohol Consumption (TAC) From Baseline at Week 12	Week 12	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	g/day	LEAST_SQUARES_MEAN
SECONDARY	Change in Total Alcohol Consumption (TAC) From Baseline at Week 24	Week 24	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	g/day	LEAST_SQUARES_MEAN
SECONDARY	Response Shift Drinking Risk Level (RSDRL) at Week 12	Week 12	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER
SECONDARY	Response Shift Drinking Risk Level (RSDRL) at Week 24	Week 24	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER
SECONDARY	Response Low Drinking Risk Level (RLDRL) at Week 12	Week 12	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER
SECONDARY	Response Low Drinking Risk Level (RLDRL) at Week 24	Week 24	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER
SECONDARY	70% TAC Responder Rate at Week 12	Week 12	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER
SECONDARY	70% TAC Responder Rate at Week 24	Week 24	Full analysis set, which included all patients who had data on the number of HDDs at baseline and at ≥1 time point after initiation of the study drug.	percentage	NUMBER

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group60

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12	Nalmefene Hydrochloride 20 mg	-12.25	Standard Error 0.64	days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12	Nalmefene Hydrochloride 10 mg	-12.09	Standard Error 0.74	days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12	Placebo	-7.91	Standard Error 0.61	days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24	Nalmefene Hydrochloride 20 mg	-13.25	Standard Error 0.66	days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24	Nalmefene Hydrochloride 10 mg	-13.88	Standard Error 0.77	days/month
Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24	Placebo	-9.33	Standard Error 0.63	days/month
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12	Nalmefene Hydrochloride 20 mg	-44.90	Standard Error 2.01	g/day
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12	Nalmefene Hydrochloride 10 mg	-45.36	Standard Error 2.32	g/day
Change in Total Alcohol Consumption (TAC) From Baseline at Week 12	Placebo	-32.43	Standard Error 1.91	g/day
Change in Total Alcohol Consumption (TAC) From Baseline at Week 24	Nalmefene Hydrochloride 20 mg	-49.43	Standard Error 2.13	g/day

1 to 10 of 60Source ClinicalTrials.gov

See all 60 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nalmefene Hydrochloride 20 mg	248
Overall Study	STARTED	Nalmefene Hydrochloride 10 mg	184
Overall Study	STARTED	Placebo	245
Overall Study	COMPLETED	Nalmefene Hydrochloride 20 mg	189
Overall Study	COMPLETED	Nalmefene Hydrochloride 10 mg	139
Overall Study	COMPLETED	Placebo	219
Overall Study	NOT COMPLETED	Nalmefene Hydrochloride 20 mg	59
Overall Study	NOT COMPLETED	Nalmefene Hydrochloride 10 mg	45
Overall Study	NOT COMPLETED	Placebo	26

Source ClinicalTrials.gov

Adverse events51

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Palpitations	Cardiac disorders	Nalmefene Hydrochloride 20 mg	13	248
other	Palpitations	Cardiac disorders	Nalmefene Hydrochloride 10 mg	7	184
other	Palpitations	Cardiac disorders	Placebo	2	245
other	Constipation	Gastrointestinal disorders	Nalmefene Hydrochloride 20 mg	13	248
other	Constipation	Gastrointestinal disorders	Nalmefene Hydrochloride 10 mg	8	184
other	Constipation	Gastrointestinal disorders	Placebo	2	245
other	Nausea	Gastrointestinal disorders	Nalmefene Hydrochloride 20 mg	79	248
other	Nausea	Gastrointestinal disorders	Nalmefene Hydrochloride 10 mg	58	184
other	Nausea	Gastrointestinal disorders	Placebo	15	245
other	Vomiting	Gastrointestinal disorders	Nalmefene Hydrochloride 20 mg	34	248

1 to 10 of 51Source ClinicalTrials.gov

See all 51 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nalmefene Hydrochloride 20 mg	0	248
Total, all-cause mortality	Nalmefene Hydrochloride 10 mg	1	184
Total, all-cause mortality	Placebo	0	245
Total, other adverse events	Nalmefene Hydrochloride 20 mg	175	248
Total, other adverse events	Nalmefene Hydrochloride 10 mg	125	184
Total, other adverse events	Placebo	127	245
Total, serious adverse events	Nalmefene Hydrochloride 20 mg	2	248
Total, serious adverse events	Nalmefene Hydrochloride 10 mg	2	184
Total, serious adverse events	Placebo	2	245

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02364947

GET https://conductscience.org/api/trials/v1/NCT02364947/results?page=2

API reference For AI assistants