Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers
Status:
Completed
Trial end date:
2003-09-01
Target enrollment:
Participant gender:
Summary
The study objective was to evaluate the safety of ten consecutive days of therapeutic
acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury
(measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to
10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11
to look for injury. We hypothesized that there would be no difference in liver enzymes
between the two groups.
Phase:
Phase 4
Details
Lead Sponsor:
Denver Health and Hospital Authority
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.