Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

This study has been completed.
Sponsor:
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by:
Denver Health and Hospital Authority
ClinicalTrials.gov Identifier:
NCT00427206
First received: January 24, 2007
Last updated: February 6, 2009
Last verified: February 2009

January 24, 2007
February 6, 2009
November 2004
December 2005   (final data collection date for primary outcome measure)
  • group mean aminotransferase measures
  • mean change in aminotransferase measures between study groups
Same as current
Complete list of historical versions of study NCT00427206 on ClinicalTrials.gov Archive Site
  • proportion of subjects that develop an aminotransferase level greater than the upper limit of reference range
  • proportion of subjects that develop hepatotoxicity (ALT>1000 IU/L)
  • proportion of subjects that develop drug induced liver injury
Same as current
Not Provided
Not Provided
 
Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing
Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

The study objective was to determine if liver injury develops in alcoholic patients during or following 5 days of therapeutic acetaminophen dosing. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4g/day) or placebo for 5 consecutive days. All subjects were monitored an additional two days following the dosing period. The primary measures were aminotransferase measures taken at baseline and Days 2, 4, 6 and 7. We hypothesized that there would be no difference in aminotransferase means between the groups at any study period.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Alcohol Related Disorders
  • Drug: acetaminophen (4g/day)
  • Drug: placebo
  • Active Comparator: 1
    acetaminophen 4 g/day
    Intervention: Drug: acetaminophen (4g/day)
  • Placebo Comparator: 2
    placebo undistinguishable from active drug
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
181
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 18 years and older
  • admitted to participating detox facility with a positive BAL at the time of admittance
  • signed a written informed consent

Exclusion Criteria:

  • serum acetaminophen level greater than 20 mcg/ml
  • serum AST or ALT levels greater than 200 IU/L
  • INR greater than 1.5
  • if female, positive for beta-subunit of chorionic gonadotropin (beta-HCG)
  • clinically intoxicated, psychiatrically impaired or unable to give informed consent
  • known hypersensitivity to acetaminophen
  • history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
  • currently enrolled in another trial or had been enrolled in another trial in the preceding three months.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00427206
COMIRB #04-0486
Yes
Not Provided
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Principal Investigator: Richard C Dart, MD, PhD Denver Health/Rocky Mountain Poison & Drug Center
Principal Investigator: Bruna Brands, PhD Centre for Addiction and Mental Health
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