Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- Change From Baseline in the Monthly Number of Heavy Drinking Days (HDDs) [ Time Frame: Baseline and Month 6 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]GGT values
- Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]ALAT values
|Study Start Date:||March 2009|
|Study Completion Date:||April 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|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™
Alcohol dependence is a maladaptive pattern of alcohol use, leading to clinically significant impairment or distress, as manifested by at least three of a number of criteria such as tolerance, withdrawal symptoms, frequent use of alcohol in larger amounts or over longer periods than was intended, and others. Excessive intake of alcohol reduces the life span by a decade, and alcohol drinking is strongly related to mortality from liver cirrhosis, chronic pancreatitis, certain cancers, hypertension, accidents and violence. This study is planned to evaluate the efficacy and safety of as needed use of nalmefene 18.06 mg versus placebo in decreasing monthly Heavy Drinking Days (HDDs) and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.
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|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|