Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics
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ClinicalTrials.gov Identifier: NCT00402571
: November 22, 2006
Last Update Posted
: February 9, 2009
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Any patient, regardless of gender or ethnicity, who was:
18 years or older
admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
signed a written informed consent form.
Patients were excluded from the study at baseline if any of the following were present:
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
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.