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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Alcohol Related Disorders
 Drug: acetaminophen (4g/day)
Drug: placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Hepatic Function Following Five Days of Therapeutic Dosing of Acetaminophen in Alcoholics

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • group mean aminotransferase measures
  • mean change in aminotransferase measures between study groups

Secondary Outcome Measures:
  • 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

Enrollment: 181
Study Start Date: November 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
acetaminophen 4 g/day
 Drug: acetaminophen (4g/day)
Placebo Comparator: 2
placebo undistinguishable from active drug
 Drug: placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00427206

Locations
United States, Colorado
Denver CARES
Denver, Colorado, United States, 80204
Canada, Ontario
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1
Sponsors and Collaborators
Denver Health and Hospital Authority
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00427206     History of Changes
Other Study ID Numbers: COMIRB #04-0486
Study First Received: January 24, 2007
Last Updated: February 6, 2009
Health Authority: Canada: Health Canada

Keywords provided by Denver Health and Hospital Authority:
acetaminophen
alcohol
liver injury

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

ClinicalTrials.gov processed this record on May 16, 2013