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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

Brief Summary:
The purpose of the study is to evaluate the efficacy, safety and tolerability of nalmefene in the treatment of alcohol dependence.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Drug: Placebo Drug: Nalmefene Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 678 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : March 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
as-needed use, tablets, orally, 6 months

Experimental: Nalmefene Drug: Nalmefene
18.06 mg, as-needed use, tablets, orally, 6 months. 18.06 mg nalmefene equals 20 mg nalmefene hydrochloride.
Other Name: Selincro™




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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).

  4. Liver Function Test Gamma-glutamyl Transferase (GGT) [ Time Frame: Week 24 ]
    GGT values

  5. Liver Function Test Alanine Aminotransferase (ALAT) [ Time Frame: Week 24 ]
    ALAT values



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00812461


  Hide Study Locations
Locations
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Belgium
BE002
Assebroek, Belgium, 8310
BE007
Brugge, Belgium, 8000
BE006
Charleroi, Belgium, 6000
BE005
Kortenberg, Belgium, 3070
BE001
Liège, Belgium, 4000
BE003
Mechelen, Belgium, 2800
BE004
Oostende, Belgium, 8400
Czech Republic
CZ001
Litomerice, Czech Republic, 41201
CZ002
Praha 10, Czech Republic, 100 00
CZ003
Praha 6, Czech Republic, 160 00
France
FR008
Angers, France, 4933
FR004
Bully les Mines, France, 62160
FR009
Clichy Cedex 92, France, 92110
FR012
Elancourt, France, 78990
FR021
La Rochelle, France, 17022
FR011
Le Pecq, France, 78230
FR019
Lille, France, 59037
FR016
Lyon, France, 69005
FR014
Nancy, France, 54000
FR015
Nimes, France, 30029
FR002
Rennes, France, 35000
FR001
Sartrouville, France, 78500
FR007
Strasbourg, France, 67000
FR005
Toulouse, France, 31000
FR006
Toulouse, France, 31200
FR003
Villejuif, France, 94804
Italy
IT017
Bologna, Italy, 40123
IT013
Bologna, Italy, 44042
IT008
Cento, Italy, 44042
IT006
Firenze, Italy, 50134
IT002
Parma, Italy, 43100
IT007
Rome, Italy, 00123
IT001
Rome, Italy, 00163
IT011
Rome, Italy, RM 00168
IT004
Rome, Italy, RM 00186
IT018
Soverato, Italy, CZ 88068
Poland
PL005
Gdansk, Poland, 80-952
PL004
Leszno, Poland, 64-100
PL006
Lublin, Poland, 20-109
PL007
Lublin, Poland, 20-442
PL002
Piekary Slaskie, Poland, 41940
PL003
Skorzewo, Poland, 60-185
PL001
Szczecin, Poland, 71-460
Portugal
PT003
Angra do Heroismo, Portugal, 9700-161
PT002
Lisboa, Portugal, 1350-179
PT001
Lisboa, Portugal, 1649-035
PT006
Mem Martins, Portugal, 2725
Spain
ES005
Alicante, Spain, 3550
ES006
Barcelona, Spain, 8003
ES008
Barcelona, Spain, 8025
ES004
Barcelona, Spain, 8028
ES014
Burgos, Spain, 9006
ES010
Madrid, Spain, 28034
ES001
Mallorca, Spain, 7193
ES002
Oviedo, Spain, 33011
ES003
Valencia, Spain, 46010
ES011
Zamora, Spain, 49021
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00812461     History of Changes
Other Study ID Numbers: 12023A
2007-002563-27 ( EudraCT Number )
First Posted: December 22, 2008    Key Record Dates
Results First Posted: July 9, 2013
Last Update Posted: July 22, 2013
Last Verified: July 2013

Keywords provided by H. Lundbeck A/S:
Pharmacologic Actions
Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents

Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ethanol
Nalmefene
Naltrexone
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Alcohol Deterrents