Phase 3
Completed N=403
A Long-term Extension Study for the Phase 3 Study of Nalmefene (339-14-001) in Patients With Alcohol Dependence
Source: ClinicalTrials.gov NCT02382276 ↗Enrolled (actual)
403
Serious AEs
0.7%
Results posted
Jul 2020
Primary outcomePrimary: Number of Participants With Adverse Events — 96; 67; 141 Number of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
96; 67; 141 | — |
| SECONDARY Change in the Number of Heavy Drinking Days (HDDs) From Baseline |
-15.09; -17.15; -16.35 | — |
| SECONDARY Change in Total Alcohol Consumption (TAC) From Baseline |
-53.20; -57.93; -55.77 | — |
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 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
Data sourced from ClinicalTrials.gov (NCT02382276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.