Status:
COMPLETED
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Lead Sponsor:
Kennon Heard
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Drug Induced Liver Injury
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver....
Eligibility Criteria
Inclusion
- age 21 years or older
- provide written informed consent
- consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers
Exclusion
- History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
- Currently taking isoniazid
- Consumption of any alcoholic beverage during the run-in period
- A detectable serum acetaminophen at baseline
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
- Platelet count less than 125,000/cc at baseline
- Positive pregnancy test at baseline (female participants only)
- Currently adheres to a fasting type diet as determined by self report
- Currently has anorexia nervosa as determined by self report
- Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
- Known hypersensitivity to acetaminophen
Key Trial Info
Start Date :
August 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00616018
Start Date
August 1 2007
End Date
January 1 2008
Last Update
July 12 2012
Active Locations (1)
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1
Denver Health Rocky Mountain Poison and Drug Center
Denver, Colorado, United States, 80204