drugset / Trial / NCT00427206

Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

NCT00427206 ↗

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

EvaluationDrugModalityDoseRoute
Comparator Acetaminophen Small molecule 4 g —