NCT02364947

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
678

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 18, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
3.2 years until next milestone

Results Posted

Study results publicly available

September 30, 2019

Completed
Last Updated

September 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

February 10, 2015

Results QC Date

August 30, 2019

Last Update Submit

September 3, 2019

Conditions

Alcohol Dependence

Outcome Measures

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

    Week 12

Secondary Outcomes (19)

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

    Week 24

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

    Week 12

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

    Week 24

  • Response Shift Drinking Risk Level (RSDRL) at Week 12

    Week 12

  • Response Shift Drinking Risk Level (RSDRL) at Week 24

    Week 24

  • +14 more secondary outcomes

Study Arms (3)

Nalmefene hydrochloride 10 mg

EXPERIMENTAL
Drug: Nalmefene hydrochloride

Nalmefene hydrochloride 20 mg

EXPERIMENTAL
Drug: Nalmefene hydrochloride

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Nalmefene hydrochlorideDRUG

As-needed; tablets, orally

Nalmefene hydrochloride 10 mgNalmefene hydrochloride 20 mg
PlaceboDRUG

As-needed; tablets, orally

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chubu

Region, Japan

Location

Hokkaido

Region, Japan

Location

Kanto

Region, Japan

Location

Kinki

Region, Japan

Location

Kyusyu

Region, Japan

Location

Tohoku

Region, Japan

Location

Tyugoku

Region, Japan

Location

MeSH Terms

Conditions

Alcoholism

Interventions

nalmefene

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Results Point of Contact

Title
Director of Clinical Trials
Organization
Otsuka Pharmaceutical Co., Ltd.
CL_OPCJ_RDA_Team@otsuka.jp

Study Officials

  • Osamu Sato

    Otsuka Pharmaceutical Co., Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 18, 2015

Study Start

February 9, 2015

Primary Completion

July 30, 2016

Study Completion

July 30, 2016

Last Updated

September 30, 2019

Results First Posted

September 30, 2019

Record last verified: 2019-07

Locations

JP(7)