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Tradipitant in Alcohol Dependence
NCT00805441Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2008
- Primary completion
- Jul 2009
- Countries
- 1
- Sponsor
- Eli Lilly and Company
- Modality
- Small Molecules
- Drugs
- tradipitant
- Conditions
- alcohol dependence
01
Overview
Phase 2, randomised, double-blind trial in alcohol dependence comparing LY686017 with Placebo (2 arms). Primary endpoint: Percent Change From Baseline in Heavy Drinking Days at 16 weeks. Started Dec 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
LY686017
Tradipitant 50 mg daily
Placebo
Placebo daily
03
Who it enrols
Adult outpatients with Alcohol Dependence, drinking heavily, without other substance dependence, serious medical illness, or major psychiatric disorders.
04
Endpoints
Primary
Percent Change From Baseline in Heavy Drinking Days
Secondary
Percent Days Abstinent Per Month
Number of Drinks Per Drinking Day During a Month
Time to First Heavy Drinking Day
Drinker Inventory of Consequences
Alcohol Urge Questionnaire
Penn Alcohol Craving Scale
Beck Depression Inventory II
Beck Anxiety Index
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