A long-term extension study for the phase 3 study of nalmefene (339-14-001) in patients with alcohol dependence

Otsuka Pharmaceutical Co., Ltd.0 sites405 target enrollmentFebruary 12, 2015

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Not specified
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Enrollment: 405
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The efficacy in reducing alcohol consumption was sustained by long-term treatment with nalmefene. Long-term treatment with nalmefene showed no notable safety concerns and was well tolerated by patients with alcohol dependence.

Registry

who.int

Start Date

February 12, 2015

End Date

January 18, 2017

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Eligibility Criteria

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 3 or 4 heart failure or angina pectoris, renal function disorder with estimated glomerular filtration rate (eGFR) of under 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.