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Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
This study has been completed.
Study NCT00616018   Information provided by Denver Health and Hospital Authority
First Received: February 4, 2008   Last Updated: February 6, 2009   History of Changes

February 4, 2008
February 6, 2009
August 2007
January 2008   (final data collection date for primary outcome measure)
serum level of APAP-Cys protein adducts [ Time Frame: before, during and following 10 days of therapy ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00616018 on ClinicalTrials.gov Archive Site
alanine aminotransferase (ALT) [ Time Frame: before, during and following 10 days of therapy ] [ Designated as safety issue: Yes ]
Same as current
 
Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days
Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days

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.

 
Phase IV
Interventional
Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Drug Induced Liver Injury
Drug: acetaminophen
Experimental: all subjects receive acetaminophen in this open-label study
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
35
January 2008
January 2008   (final data collection date for primary outcome measure)

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 four 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 ALT or 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
Both
21 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00616018
Kennon Heard, MD/Medical Toxicology Fellowship Director, Denver Health/Rocky Mountain Poison and Drug Center
COMIRB #06-1187, COMIRB #06-1187
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Principal Investigator: Kennon Heard, MD Denver Health/Rocky Mountain Poison & Drug Center
Denver Health and Hospital Authority
February 2009

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