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NCT02382276 Clinical Trial

A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Alcohol Dependence Clinical Trial

Official title:
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02382276
Other study ID # 339-14-002
Secondary ID JapicCTI-152806
Status Completed
Phase Phase 3
First received
Last updated
Start date July 13, 2015
Est. completion date January 18, 2017

Study information
Verified date July 2020
Source Otsuka Pharmaceutical Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The long-term safety and efficacy of nalmefene hydrochloride at 20 mg in patients with alcohol dependence will be evaluated in a multicenter, open-label, uncontrolled trial.

Recruitment information / eligibility
Status Completed
Enrollment 405
Est. completion date January 18, 2017
Est. primary completion date January 18, 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Patients who have completed Study 339-14-001

- Patients who have signed the informed consent form for Study 339-14-002

Exclusion Criteria:

- The patient has a clinically significant unstable illness (eg, complication of New York Heart Association (NYHA) class III or IV heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2, hepatic failure, and neoplastic disorder)

- The patient has a clinically significant abnormal electrocardiogram (ECG) which is inappropriate for the participation in the trial in the opinion of the investigator or subinvestigator

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nalmefene hydrochloride

Locations
Country Name City State
Japan Chubu Region
Japan Hokkaido Region
Japan Kanto Region
Japan Kinki Region
Japan Kyusyu Region
Japan Tohoku Region
Japan Tyugoku Region

Sponsors (2)
Lead Sponsor Collaborator
Otsuka Pharmaceutical Co., Ltd. H. Lundbeck A/S

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants With Adverse Events 24-week treatment period
Secondary Change in the Number of Heavy Drinking Days (HDDs) From Baseline Week 24
Secondary Change in Total Alcohol Consumption (TAC) From Baseline Week 24
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