Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Status:
Completed
Trial end date:
2004-07-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Denver Health and Hospital Authority
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.