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Trial intelligence / Profile preview
Metadoxine for Alcoholism and Alcohol Liver Disease
NCT01504295Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2012
- Primary completion
- Jan 2015
- Countries
- 1
- Sponsor
- Brown University
- Modality
- Small Molecules
- Drugs
- Metadoxine
- Conditions
- alcohol use disorder (AUD)alcoholic liver disease (ALD)
01
Overview
Phase 2, randomised, double-blind trial of Metadoxine in alcohol use disorder (AUD) and alcoholic liver disease (ALD) (2 arms), sponsored by Brown University. Primary endpoint: Percent Days Abstinent at 12 weeks. Started Apr 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metadoxine
Metadoxine 500mg tablet t.i.d. for 12 weeks
Sugar pill
Placebo group
03
Who it enrols
Adults with alcohol use disorder and alcoholic liver disease, desiring abstinence, excluding those with severe psychiatric disorders, other substance dependence, or severe decompensated liver disease.
04
Endpoints
Primary
Percent Days Abstinent
Secondary
Follow-up Percent Days Abstinent
Adverse Events
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