Clinical Trial: Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study
Brief Summary: The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.
Detailed Summary:
Sponsor: Denver Health and Hospital Authority
Current Primary Outcome: mean change in serum aminotransferase levels between study groups
Original Primary Outcome: Same as current
Current Secondary Outcome:
- proportion of subjects tht developed an abnormal aminotransferase level
- proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)
- proportion of subjects that developed drug induced liver injury
Original Secondary Outcome: Same as current
Information By: Denver Health and Hospital Authority
Dates:
Date Received: November 20, 2006
Date Started: January 2002
Date Completion: July 2004
Last Updated: February 6, 2009
Last Verified: February 2009
