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Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days (Non-Drinker)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616018
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : July 12, 2012
Last Update Posted : July 12, 2012
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Kennon Heard, Denver Health and Hospital Authority

Tracking Information
First Submitted Date  ICMJE February 4, 2008
First Posted Date  ICMJE February 14, 2008
Results First Submitted Date  ICMJE March 3, 2011
Results First Posted Date  ICMJE July 12, 2012
Last Update Posted Date July 12, 2012
Study Start Date  ICMJE August 2007
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 10, 2012)
Serum Level of Acetaminophen-cysteine (APAP-Cys) Protein Adducts [ Time Frame: Day 0, 4, 7, 9, 11, and 14. ]
Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.
Original Primary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
serum level of APAP-Cys protein adducts [ Time Frame: before, during and following 10 days of therapy ]
Change History Complete list of historical versions of study NCT00616018 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2012)
Alanine Aminotransferase (ALT) [ Time Frame: Day 0, 4, 7, 9, 11, and 14. ]
ALT was measured at Day 0, 4, 7, 9, 11, and 14.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2008)
Alanine Aminotransferase (ALT) [ Time Frame: before, during and following 10 days of therapy ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Official Title  ICMJE Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Brief Summary Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Drug Induced Liver Injury
Intervention  ICMJE Drug: acetaminophen
4 g/day for 10 consecutive days
Other Name: Tylenol Extra Strength
Study Arms  ICMJE Experimental: A
all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
Intervention: Drug: acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2008)
35
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date January 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. age 21 years or older
  2. provide written informed consent
  3. consume, on average, less than 1 alcoholic beverage daily for the previous 3 months and would be considered non-drinkers

Exclusion Criteria:

  1. History of ingesting more than 4 grams of acetaminophen per day for any of the 4 days preceding study enrollment
  2. Currently taking isoniazid
  3. Consumption of any alcoholic beverage during the run-in period
  4. A detectable serum acetaminophen at baseline
  5. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 50 IU/L at the start of the run-in period or at baseline
  6. Platelet count less than 125,000/cc at baseline
  7. Positive pregnancy test at baseline (female participants only)
  8. Currently adheres to a fasting type diet as determined by self report
  9. Currently has anorexia nervosa as determined by self report
  10. Subject appears clinically intoxicated, psychiatrically impaired or unable to give informed consent for any reason
  11. Known hypersensitivity to acetaminophen
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00616018
Other Study ID Numbers  ICMJE COMIRB #06-1187
COMIRB #06-1187
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kennon Heard, Denver Health and Hospital Authority
Study Sponsor  ICMJE Kennon Heard
Collaborators  ICMJE McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators  ICMJE
Principal Investigator: Kennon Heard, MD Denver Health/Rocky Mountain Poison & Drug Center
PRS Account Denver Health and Hospital Authority
Verification Date July 2012

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