Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Status:
Completed
Trial end date:
2005-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
Denver Health and Hospital Authority
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.