Phase 3
Completed N=677
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)
Source: ClinicalTrials.gov NCT02364947 ↗Enrolled (actual)
677
Serious AEs
0.9%
Results posted
Sep 2019
Primary outcomePrimary: Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12 — -12.25; -12.09; -7.91 days/month — p=0.0001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 12 |
-12.25; -12.09; -7.91 | 0.0001 sig |
| SECONDARY Change in the Number of Heavy Drinking Days (HDDs) From Baseline at Week 24 |
-13.25; -13.88; -9.33 | <0.0001 sig |
| SECONDARY Change in Total Alcohol Consumption (TAC) From Baseline at Week 12 |
-44.90; -45.36; -32.43 | <0.0001 sig |
| SECONDARY Change in Total Alcohol Consumption (TAC) From Baseline at Week 24 |
-49.43; -49.55; -38.28 | 0.0001 sig |
| SECONDARY Response Shift Drinking Risk Level (RSDRL) at Week 12 |
41.3; 35.7; 20.1 | <0.0001 sig |
| SECONDARY Response Shift Drinking Risk Level (RSDRL) at Week 24 |
44.4; 47.5; 27.5 | 0.0002 sig |
| SECONDARY Response Low Drinking Risk Level (RLDRL) at Week 12 |
29.6; 25.3; 10.7 | <0.0001 sig |
| SECONDARY Response Low Drinking Risk Level (RLDRL) at Week 24 |
29.6; 32.6; 17.6 | 0.0079 sig |
| SECONDARY 70% TAC Responder Rate at Week 12 |
18.0; 19.5; 8.5 | 0.0022 sig |
| SECONDARY 70% TAC Responder Rate at Week 24 |
23.8; 23.4; 10.8 | 0.0003 sig |
| SECONDARY HDD Responder Rate at Week 12 |
35.0; 36.4; 19.2 | 0.0002 sig |
| SECONDARY HDD Responder Rate at Week 24 |
33.9; 44.0; 25.2 | 0.0724 |
| SECONDARY Change in CGI-S From Baseline at Week 12 |
-0.60; -0.63; -0.34 | 0.0002 sig |
| SECONDARY Change in CGI-S From Baseline at Week 24 |
-0.75; -0.77; -0.41 | <0.0001 sig |
| SECONDARY Change in CGI-I From Baseline at Week 12 |
2.62; 2.65; 3.13 | <0.0001 sig |
| SECONDARY Change in CGI-I From Baseline at Week 24 |
2.49; 2.44; 2.99 | <0.0001 sig |
| SECONDARY Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 12 |
3.666; 3.702; 3.858 | <0.0001 sig |
| SECONDARY Change in Logarithm Scale in Serum γ-glutamyltransferase From Baseline at Week 24 |
3.663; 3.692; 3.831 | <0.0001 sig |
| SECONDARY Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 12 |
2.968; 2.988; 3.038 | 0.0234 sig |
| SECONDARY Change in Logarithm Scale in Serum Alanine Aminotransferase From Baseline at Week 24 |
2.971; 2.987; 3.036 | 0.0348 sig |
Eligibility Criteria
Inclusion Criteria
- Japanese males and females aged 20 or above who have signed the informed consent form
- The patient has alcohol dependence, diagnosed according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) and confirmed by Mini-international Neuropsychiatric Interview (M. I. N. I.)
- The patient has a drinking risk level of High or above (> 60 g for men and > 40 g for women) both at the Screening Visit and at the Randomization Visit .
Exclusion Criteria
- The patient with a current diagnosis or history of substance use disorders (except for alcohol, nicotine, and caffeine), according to DSM-IV-TR and confirmed by M. I. N. I.
- The patient has reported current use of, or has tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines, barbiturates) at the screening test
Data sourced from ClinicalTrials.gov (NCT02364947). 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.