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

• Status: Completed
• Trial end date: 2017-01-18
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.
• Collaborator: H. Lundbeck A/S
• Treatments: Nalmefene; Naltrexone

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 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