drugset / Trial / NCT00402571
Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
Phase 4
Completed
420 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 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.
Timeline
- Start
- 2002-01
- Primary completion
- —
- Completion
- 2004-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Acetaminophen | Small molecule | 4 g | — |