Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)
|ClinicalTrials.gov Identifier: NCT00812461|
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : July 9, 2013
Last Update Posted : July 22, 2013
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence||Drug: Placebo Drug: Nalmefene||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||678 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Nalmefene Efficacy Study II: Randomised, Double-blind, Placebo-controlled, Parallel-group, Efficacy Study of 20 mg Nalmefene, as Needed Use, in Patients With Alcohol Dependence|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||April 2011|
|Placebo Comparator: Placebo||
as-needed use, tablets, orally, 6 months
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Other Name: Selincro™
- Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [ Time Frame: Baseline and Month 6 ]Number of HDDs over a month (28 days), where one HDD was defined as a day with alcohol consumption ≥60 grams (g) for men and ≥40 g for women.
- Change From Baseline in the Monthly Total Alcohol Consumption (TAC) [ Time Frame: Baseline and Month 6 ]TAC was defined as mean daily alcohol consumption in g/day over a month (28 days).
- Drinking Risk Level (RSDRL) Response [ Time Frame: Month 6 ]RSDRL response was defined as a downward shift from baseline in Drinking Risk Level (DRL); for patients at very high risk at Baseline: a shift to medium risk or below, and for patients at high or medium risk at Baseline: a shift to low risk or below.
- Change From Baseline in Clinical Status Using CGI-S [ Time Frame: Baseline and Week 24 ]The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients).
- Change in Clinical Status Using the CGI-I [ Time Frame: Week 24 ]The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse).
- Liver Function Test Gamma-glutamyl Transferase (GGT) [ Time Frame: Week 24 ]GGT values
- Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 24 ]ALAT values
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812461
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|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|