Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Denver Health and Hospital Authority
• Collaborator: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• 18 years and older

• admitted to participating detox facility with a positive BAL at the time of admittance

• signed a written informed consent

Exclusion Criteria:

• serum acetaminophen level greater than 20 mcg/ml

• serum AST or ALT levels greater than 200 IU/L

• INR greater than 1.5

• if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)

• clinically intoxicated, psychiatrically impaired or unable to give informed consent

• known hypersensitivity to acetaminophen

• history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment

• currently enrolled in another trial or had been enrolled in another trial in the preceding three months.