drugset / Trial / NCT00400621
Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers
Phase 4
Completed
150 enrolled
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. · collab
RandomizedSingle-groupDouble-blind
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.
Timeline
- Start
- 2003-04
- Primary completion
- —
- Completion
- 2003-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | — | — |
Indications
No indication recorded.