Safety 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:	NCT00811941

Purpose

The purpose of the study is long-term safety and tolerability of nalmefene in patients with alcohol dependence.

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

MedlinePlus related topics: Alcoholism

Drug Information available for: Ethanol Morphinan-3,14-diol, 17-(cyclopropylmethyl)-4,5-epoxy-6-methylene-, hydrochloride, (5alpha)- Nalmefene

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety Study
Official Title:	A 52-Week, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Safety and Tolerability Study of Nalmefene, as Needed Use, in Patients With Alcohol Dependence

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

Primary Outcome Measures:

Safety is measured by adverse events, clinical safety laboratory tests, vital signs, weight, body mass index, electrocardiograms, profile of moods states and physical examination. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Reduction of alcohol consumption; Alcohol dependence symptoms and clinical status; Liver function and other laboratory tests; Pharmacoeconomic outcomes [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	668
Study Start Date:	February 2009
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Nalmefene 20 mg, as needed, orally, 52 weeks
2: Placebo Comparator	Drug: Placebo as needed, orally, 52 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 long-term safety and tolerability of as needed use of 20 mg nalmefene versus placebo over a period of 52 weeks in 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 severe psychiatric disorder
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 tremens 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 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: NCT00811941

Contacts

Contact: Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

Sponsors and Collaborators

H. Lundbeck A/S

Investigators

Study Director:

Email contact via H. Lundbeck A/S

LundbeckClinicalTrials@lundbeck.com

More Information

Responsible Party:	H. Lundbeck A/S ( H. Lundbeck A/S )
Study ID Numbers:	12013A, EudraCT 2007-002315-92
Study First Received:	December 18, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00811941
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Hungary: National Institute of Pharmacy; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Ministry of Health and Social Development of the Russian Federation; Slovakia: State Institute for Drug Control; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency

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
Alcoholism
Substance-Related Disorders
Disorders of Environmental Origin

Alcohol-Related Disorders
Nalmefene
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009