A Multicenter, Randomized, Double-blind, Placebo-controlled, 3-parallel-group Comparison Trial to Investigate the Effect of Nalmefene on Alcohol Consumption Reduction in Patients With Alcohol Dependence (Phase 3 Trial)
Summary
The efficacy, safety, and dose-response of nalmefene hydrochloride at 10 mg and 20 mg in patients with alcohol dependence will be evaluated in a multicenter, randomized, double-blind, placebo-controlled, 3-parallel-group comparative trial. The superiority of nalmefene hydrochloride at 20 mg to placebo will be verified in terms of reduction of alcohol consumption.
Timeline
- Start
- 2015-02-09
- Primary completion
- 2016-07-30
- Completion
- 2016-07-30
Outcome
Met primary endpoint
registry analysis (unspecified test); Nalmefene Hydrochloride 20 mg vs Placebo; p = 0.0001; Mean Difference (Final Values) -4.34 (95% CI -6.05 to -2.62); NCT02364947 ↗
release “In the initial 24-week comparative trial, a statistically significant difference (P <0.0001) was observed between nalmefene and placebo for the primary endpoint” otsuka.co.jp ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalmefene | Small molecule | 10 mg | Oral |
| Subject | Nalmefene | Small molecule | 20 mg | Oral |