drugset / Trial / NCT00427206
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Phase 4
Completed
181 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 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.
Timeline
- Start
- 2004-11
- Primary completion
- 2005-12
- Completion
- 2005-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acetaminophen | Small molecule | 4 g | — |