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Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind


Related Conditions & MeSH terms


NCT number NCT00400621
Study type Interventional
Source Denver Health and Hospital Authority
Contact
Status Completed
Phase Phase 4
Start date April 2003
Completion date September 2003