Acetaminophen-Protein Adduct Resolution
Information source: Denver Health and Hospital Authority
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acetaminophen
Phase: N/A
Status: Recruiting
Sponsored by: Denver Health and Hospital Authority Official(s) and/or principal investigator(s):
Kennon Heard, MD, Principal Investigator, Affiliation: Denver Health and Hospital Authority
Overall contact:
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Summary
The purpose of this study is to better understand the pharmacokinetics of acetaminophen and
further clinical interpretations of laboratory results that confirm the presence of
acetaminophen-cys adducts. This study will determine how long adducts persist in serum after
a therapeutic course of acetaminophen as taken in a previous study (COMIRB 06-1265).
Subjects will be asked to complete three study visits, each three days apart, following
termination of COMIRB 06-1265. Each study visit will include collection of blood samples for
batch testing of aminotransferase, serum acetaminophen and protein adducts. No interventions
are planned.
Clinical Details
Official title: Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: The primary outcome of the proposed study is to determine the proportion of subjects with acetaminophen-cys adduct concentrations above the limit of quantification at day 6 after stopping maximum acetaminophen dosing.
Secondary outcome: The secondary outcomes of the proposed study are the serum acetaminophen-cys adduct concentrations at 3, 6, 9 days after stopping maximum acetaminophen dosing of the COMIRB 06-1265 study.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Any subject randomized to the acetaminophen arm of COMIRB 06-1265 and meets
completion criteria
Exclusion Criteria:
- Subjects who enter the extended dosing period in protocol 06-1265.
- Subjects who were randomized to placebo.
Locations and Contacts
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
University of Colorado Hospital CTRC, Aurora, Colorado 80045, United States; Recruiting
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Denver Health and Hospital Authority, Denver, Colorado 80204, United States; Recruiting
Jody L Green, PhD, Phone: 303-389-1246, Email: jody.green@rmpdc.org
Kennon Heard, MD, Principal Investigator
Additional Information
Starting date: November 2009
Last updated: June 21, 2010
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