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
  Purpose

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.


Condition
Acetaminophen-protein Adduct Formation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Serum Acetaminophen-Cysteine (APAP-cys) Adduct Concentrations After 16 Days of Acetaminophen Dosing

Resource links provided by NLM:


Further study details as provided by Denver Health and Hospital Authority:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA

serum


Enrollment: 100
Study Start Date: November 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Acetaminophen Group
Subjects who completed COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

All subjects who have met completion criteria for COMIRB 06-1265 and were assigned to the acetaminophen treatment group for that study.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021410

Locations
United States, Colorado
University of Colorado Hospital CTRC
Aurora, Colorado, United States, 80045
Denver Health and Hospital Authority
Denver, Colorado, United States, 80204
Sponsors and Collaborators
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Principal Investigator: Kennon Heard, MD Denver Health and Hospital Authority
  More Information

No publications provided

Responsible Party: Kennon Heard, Fellowship Director, Denver Health and Hospital Authority
ClinicalTrials.gov Identifier: NCT01021410     History of Changes
Other Study ID Numbers: COMIRB 09-0510
Study First Received: November 25, 2009
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Denver Health and Hospital Authority:
acetaminophen
paracetamol
protein adduct
healthy volunteer
acetaminophen-protein adduct formation

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics

ClinicalTrials.gov processed this record on August 28, 2014