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Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)

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ClinicalTrials.gov Identifier: NCT00812461
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : July 9, 2013
Last Update Posted : July 22, 2013
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S

Tracking Information
First Submitted Date  ICMJE December 19, 2008
First Posted Date  ICMJE December 22, 2008
Results First Submitted Date  ICMJE March 12, 2013
Results First Posted Date  ICMJE July 9, 2013
Last Update Posted Date July 22, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
  • 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).
Original Primary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
Change from baseline in the monthly number of heavy drinking days. Change from baseline in the total alcohol consumption. [ Time Frame: 24 weeks ]
Change History Complete list of historical versions of study NCT00812461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2013)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
Proportion of responders based on drinking measures; Alcohol dependence symptoms and clinical status; Liver function and other laboratory tests; Pharmacoeconomic outcomes; Treatment discontinuation effects; Safety and tolerability [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Nalmefene in Patients With Alcohol Dependence
Official Title  ICMJE 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
Brief Summary The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Dependence
Intervention  ICMJE
  • Drug: Placebo
    as-needed use, tablets, orally, 6 months
  • Drug: Nalmefene
    18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
    Other Name: Selincro™
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Nalmefene
    Intervention: Drug: Nalmefene
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2013)
678
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2008)
600
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

In- and outpatients who:

  • had a primary diagnosis of alcohol dependence according to Diagnostic and Statistical Manual of Mental Disorders - text revision (DSM-IV-TR) criteria
  • had had ≥6 HDDs in the 4 weeks preceding the Screening Visit
  • had had an average alcohol consumption at WHO medium risk level or above in the 4 weeks preceding the Screening Visit

Exclusion Criteria:

The patient:

  • had a DSM-IV Axis I disorder other than alcohol dependence or nicotine dependence
  • had an antisocial personality disorder
  • had risk of suicide evaluated by the suicidality module of the Mini-International Neuropsychiatric Interview (MINI)
  • had a history of delirium tremens or alcohol withdrawal seizures
  • reported current or recent (within 3 months preceding screening) treatment with disulfiram, acamprosate, topiramate, naltrexone or carbimide, or with any opioid antagonists
  • reported current or recent treatment with antipsychotics or antidepressants
  • was pregnant or breast-feeding

Other protocol-defined inclusion and exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Czech Republic,   France,   Italy,   Poland,   Portugal,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00812461
Other Study ID Numbers  ICMJE 12023A
2007-002563-27 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party H. Lundbeck A/S
Study Sponsor  ICMJE H. Lundbeck A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account H. Lundbeck A/S
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP