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

Otsuka

Status and phase: Completed; Phase 3

Conditions: Alcohol Dependence

Treatments: Drug: Nalmefene hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT02382276

JapicCTI-152806 (Other Identifier)

339-14-002

Details and patient eligibility

About

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.

Enrollment: 405 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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405 participants in 1 patient group

Nalmefene hydrochloride 20 mg

Experimental group

Description:

As-needed; tablets, orally

Treatment:

Drug: Nalmefene hydrochloride