Status:
COMPLETED
Aminotransferase Trends During Prolonged Acetaminophen Dosing
Lead Sponsor:
Denver Health and Hospital Authority
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Drug Toxicity
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to peo...
Detailed Description
Acetaminophen use is common and many consumers take 4g/day for longer than 4 days. The use of 4g/day of acetaminophen for more than 4 days causes an asymptomatic ALT elevation in some people. This ele...
Eligibility Criteria
Inclusion
- age 18 or older
Exclusion
- History of acetaminophen ingestion on any of the four days preceding study enrollment
- Measurable serum acetaminophen level at time of enrollment
- Viral markers of Hepatitis B or C, or viral markers of Hepatitis A with an ALT level greater than ULN during screening laboratory testing
- Serum ALT or AST level greater than ULN at Screening or Day 0
- Total bilirubin level greater than ULN at Screening or Day 0
- INR level greater than ULN at Screening
- Alkaline phosphatase level greater than ULN at Screening
- Platelet count less than 125 10\^9/L at Screening
- Known cholelithiasis
- Positive pregnancy test at Screening (female participants only)
- History of consuming more than an average of 3 alcohol containing drinks daily over the preceding 2 weeks
- History of consuming 3 or more alcohol containing drinks on any given day during the 2 weeks prior to study enrollment
- New prescription medication started within the previous 30 days
- Currently taking isoniazid
- Currently taking warfarin
- Currently adheres to a fasting type diet as determined by self report
- Currently has anorexia nervosa as determined by self report
- Participant is clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
- Known hypersensitivity or allergy to acetaminophen
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT00743093
Start Date
August 1 2008
End Date
August 1 2011
Last Update
September 18 2013
Active Locations (2)
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1
University of Colorado Health Sciences Center - GCRC
Aurora, Colorado, United States, 80045
2
Denver Health Rocky Mountain Poison and Drug Center
Denver, Colorado, United States, 80204