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

Phase 3

Completed

• Conditions: Alcohol dependent

• Registration Number: JPRN-jRCT2080222754
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-02-12
• Study Completion: 2017-01-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 405

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified