Efficacy of Nalmefene in Patients With Alcohol Dependence - Full Text View

Sponsored by:	H. Lundbeck A/S
Information provided by:	H. Lundbeck A/S
ClinicalTrials.gov Identifier:	NCT00812461

Purpose

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

Condition	Intervention	Phase
Alcohol Dependence	Drug: Nalmefene Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Nalmefene Nalmefene hydrochloride

U.S. FDA Resources

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:

Change from baseline in the monthly number of heavy drinking days. Change from baseline in the total alcohol consumption. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	600
Study Start Date:	March 2009
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Nalmefene 20 mg, as needed, orally, 24 weeks
2: Placebo Comparator	Drug: Placebo as needed, orally, 24 weeks

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 20 mg versus placebo in decreasing monthly heavy drinking days and decreasing the total consumption during a period of 24 weeks in adult patients with alcohol dependence.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

The patient has alcohol dependence diagnosed according to DSM-IV-TR

Exclusion Criteria:

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

Other protocol-defined inclusion and exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812461

Contacts

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Locations

France
FR005	Recruiting
Toulouse, France, 31000
FR002	Recruiting
Rennes, France, 35000
FR003	Recruiting
Villejuif, France, 94804
FR007	Recruiting
Strasbourg, France, 67000
FR006	Recruiting
Toulouse, France, 31200
FR004	Recruiting
Bully les Mines, France, 62160
FR009	Recruiting
Clichy Cedex 92, France, 92110
FR012	Recruiting
Elancourt, France, 78990
Spain
ES001	Recruiting
Mallorca, Spain, 7193
ES004	Recruiting
Barcelona, Spain, 8028
ES006	Recruiting
Barcelona, Spain, 8003
ES010	Recruiting
Madrid, Spain, 28034

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

No publications provided

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12023A, EudraCT 2007-002563-27
Study First Received:	December 19, 2008
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00812461 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; Italy: The Italian Medicines Agency; Portugal: National Pharmacy and Medicines Institute; Spain: Spanish Agency of Medicines

Keywords provided by H. Lundbeck A/S:

Pharmacologic Actions
Alcohol-Related Disorders
Alcoholism
Mental Disorders
Central Nervous System Agents

Study placed in the following topic categories:

Mental Disorders
Narcotic Antagonists
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Narcotics
Alcohol-Related Disorders
Peripheral Nervous System Agents
Nalmefene
Ethanol

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Disorders of Environmental Origin
Pharmacologic Actions
Mental Disorders
Sensory System Agents
Therapeutic Uses

Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents
Nalmefene

ClinicalTrials.gov processed this record on August 28, 2009