Aminotransferase Trends During Prolonged Acetaminophen Dosing
Information source: Denver Health and Hospital Authority
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Drug Toxicity; Healthy
Intervention: acetaminophen (Drug); placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Denver Health and Hospital Authority Official(s) and/or principal investigator(s):
Kennon Heard, MD, Principal Investigator, Affiliation: Denver Health/Rocky Mountain Poison & Drug Center
Overall contact:
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
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.
Clinical Details
Official title: Aminotransferase Trends During Prolonged Therapeutic Acetaminophen Dosing
Study design: Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: alanine aminotransferase (ALT)
Secondary outcome: acetaminophen-protein adducts
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 elevation most likely resolves while continuing treatment, but it is possible
that some individuals may go on to develop clinical liver injury. By carefully following
healthy subjects who are taking the maximal daily dose of acetaminophen, we can safely
determine if the ALT elevation resolves or progresses to clinical liver injury. If a subject
develops clinical liver injury we can intervene before irreversible injury occurs.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- age 18 or older
Exclusion Criteria:
1. History of acetaminophen ingestion on any of the four days preceding study enrollment
2. Measurable serum acetaminophen level at time of enrollment
3. Viral markers of Hepatitis A, B or C during screening laboratory testing
4. Serum ALT or AST level greater than ULN at baseline
5. Total bilirubin level greater than ULN at baseline
6. INR level greater than ULN at baseline
7. Alkaline phosphatase level greater than ULN at baseline
8. Platelet count less than 125,000/mL at baseline
9. Known cholelithiasis
10. Positive pregnancy test at baseline (female participants only)
11. History of consuming more than an average of 3 alcohol containing drinks daily over
the preceding 2 weeks
12. History of consuming 3 or more alcohol containing drinks on any given day during the
2 weeks prior to study enrollment
13. New prescription medication started within the previous 30 days
14. Currently taking isoniazid
15. Currently taking warfarin
16. Currently adheres to a fasting type diet as determined by self report
17. Currently has anorexia nervosa as determined by self report
18. Participant is clinically intoxicated, psychiatrically impaired or unable to give
informed consent for any reason
19. Known hypersensitivity or allergy to acetaminophen
Locations and Contacts
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Denver Health Rocky Mountain Poison and Drug Center, Denver, Colorado 80204, United States; Recruiting
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Kennon Heard, MD, Principal Investigator
University of Colorado Health Sciences Center - GCRC, Aurora, Colorado 80045, United States; Recruiting
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Kennon Heard, MD, Principal Investigator
Additional Information
Related publications: Case JP, Baliunas AJ, Block JA. Lack of efficacy of acetaminophen in treating symptomatic knee osteoarthritis: a randomized, double-blind, placebo-controlled comparison trial with diclofenac sodium. Arch Intern Med. 2003 Jan 27;163(2):169-78. Davern TJ 2nd, James LP, Hinson JA, Polson J, Larson AM, Fontana RJ, Lalani E, Munoz S, Shakil AO, Lee WM; Acute Liver Failure Study Group. Measurement of serum acetaminophen-protein adducts in patients with acute liver failure. Gastroenterology. 2006 Mar;130(3):687-94. Erratum in: Gastroenterology. 2006 May;130(6):1933. García Rodríguez LA, González-Pérez A. Long-term use of non-steroidal anti-inflammatory drugs and the risk of myocardial infarction in the general population. BMC Med. 2005 Nov 29;3:17. Golden HE, Moskowitz RW, Minic M. Analgesic efficacy and safety of nonprescription doses of naproxen sodium compared with acetaminophen in the treatment of osteoarthritis of the knee. Am J Ther. 2004 Mar-Apr;11(2):85-94.
Starting date: August 2008
Ending date: January 2011
Last updated: September 17, 2009
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