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Acetaminophen-Protein Adduct Resolution (AR)

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Kennon Heard, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT01021410
First received: November 25, 2009
Last updated: August 7, 2012
Last verified: August 2012
History of Changes

November 25, 2009
August 7, 2012
November 2009
March 2011   (final data collection date for primary outcome measure)
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. [ Time Frame: Day 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01021410 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Days 3, 6, 9 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Acetaminophen-Protein Adduct Resolution
Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum
Non-Probability Sample

All subjects who have met completion criteria for COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.
Acetaminophen-protein Adduct Formation
Not Provided
Acetaminophen Group
Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01021410
COMIRB 09-0510
No
Kennon Heard, Denver Health and Hospital Authority
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Principal Investigator: Kennon Heard, MD Denver Health and Hospital Authority
Denver Health and Hospital Authority
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP