Trials / Completed
CompletedNCT02364947
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 678 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Nalmefene hydrochloride | As-needed; tablets, orally |
| DRUG | Placebo | As-needed; tablets, orally |
Timeline
- Start date
- 2015-02-09
- Primary completion
- 2016-07-30
- Completion
- 2016-07-30
- First posted
- 2015-02-18
- Last updated
- 2019-09-30
- Results posted
- 2019-09-30
Locations
7 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT02364947. Inclusion in this directory is not an endorsement.