Aminotransferase Trends During Prolonged Acetaminophen Dosing
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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 people taking placebo for 16 to 40 days. Those people that continue to have
normal liver tests after 16 days will have completed their part of the study. People that
develop abnormal liver function tests will continue taking acetaminophen or placebo, and have
their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure
these tests return to normal and (2) determine when these tests return to normal while still
taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a
minor increase, you would be immediately told to stop taking the study drug.
Secondary objective is to determine the proportion of subjects that have detectable
acetaminophen-protein adducts after daily dosing.
Phase:
Phase 4
Details
Lead Sponsor:
Denver Health and Hospital Authority
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.