Efficacy of Nalmefene in Patients With Alcohol Dependence (ESENSE2)

July 17, 2013 updated by: H. Lundbeck A/S

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
678

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • Selincro™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline and Month 6
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).
Baseline and Month 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Month 6
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).
Baseline and Week 24
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).
Week 24
Liver Function Test Gamma-glutamyl Transferase (GGT)
Time Frame: Week 24
GGT values
Week 24
Liver Function Test Alanine Aminotransferase (ALAT)
Time Frame: Week 24
ALAT values
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12023A
  • 2007-002563-27 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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