Status:
COMPLETED
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Alcohol Related Disorders
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 detoxif...
Eligibility Criteria
Inclusion
- 18 years and older
- admitted to participating detox facility with a positive BAL at the time of admittance
- signed a written informed consent
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00427206
Start Date
November 1 2004
End Date
December 1 2005
Last Update
February 9 2009
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Denver CARES
Denver, Colorado, United States, 80204
2
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1