NCT00427206

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 181 (actual)
• Sponsor: Denver Health and Hospital Authority · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.

Conditions

• Alcohol Related Disorders

Interventions

Type	Name	Description
DRUG	acetaminophen (4g/day)
DRUG	placebo

Timeline

• Start date: 2004-11-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2007-01-26
• Last updated: 2009-02-09

Locations

2 sites across 2 countries: United States, Canada