Status:
COMPLETED
Safety and Efficacy of Nalmefene in Patients With Alcohol Dependence
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is long-term safety, tolerability and efficacy of nalmefene in patients with 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, withdra...
Eligibility Criteria
Inclusion
- 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 Heavy Drinking Days (HDDs) in the 4 weeks preceding the Screening Visit
Exclusion
- The patient:
- had a severe psychiatric disorder or 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
- was pregnant or breast-feeding
- Other protocol-defined inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
665 Patients enrolled
Trial Details
Trial ID
NCT00811941
Start Date
March 1 2009
End Date
November 1 2010
Last Update
August 7 2013
Active Locations (60)
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1
CZ007
Litoměřice, Czechia, 412 01
2
CZ006
Lnáře, Czechia, 38742
3
CZ005
Prague, Czechia, 100 00
4
CZ004
Prague, Czechia, 160 00