Hepatic Function During and Following Three Days of Acetaminophen Dosing in Alcoholics

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:
NCT00402571
First received: November 20, 2006
Last updated: February 6, 2009
Last verified: February 2009
  Purpose

The study objective was to determine whether liver injury develops in alcoholic patients who ingest therapeutic doses of APAP for three consecutive days. Volunteers were recruited from two community detoxification centers to take either acetaminophen (4 g/day) or placebo for 3 consecutive days and remain in the facility an additional 2 days for monitoring. The primary measures were aminotransferase measures taken at baseline and Days 2-5. We hypothesized that there would be no difference in aminotransferase measures between the acetaminophen and placebo study groups.


Condition Intervention Phase
Alcohol Related Disorders
Drug: acetaminophen
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Official Title: Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • mean change in serum aminotransferase levels between study groups

Secondary Outcome Measures:
  • proportion of subjects tht developed an abnormal aminotransferase level
  • proportion of subjects that developed hepatotoxicity (ALT>1000 IU/L)
  • proportion of subjects that developed drug induced liver injury

Estimated Enrollment: 420
Study Start Date: January 2002
Estimated Study Completion Date: July 2004
  Eligibility

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

Inclusion Criteria

Any patient, regardless of gender or ethnicity, who was:

  1. 18 years or older
  2. admitted to one of the two controlled access alcohol detoxification centers with a positive BAL at the time of admittance
  3. signed a written informed consent form.

Patients were excluded from the study at baseline if any of the following were present:

  1. serum acetaminophen level greater than 20 mcg/ml
  2. serum AST or ALT levels greater than 200 IU/L
  3. INR greater than 1.5
  4. if female, positive for beta-subunit of chorionic gonadotropin
  5. clinically intoxicated, psychiatrically impaired or unable to give informed consent
  6. known hypersensitivity to acetaminophen
  7. history of ingesting more than four grams of APAP per day for any of the four days preceding study enrollment
  8. 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: NCT00402571

Locations
United States, Colorado
Denver CARES
Denver, Colorado, United States, 80204
United States, Washington
Recovery Centers of King County
Seattle, Washington, United States, 98122
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00402571     History of Changes
Other Study ID Numbers: COMIRB #00-715
Study First Received: November 20, 2006
Last Updated: February 6, 2009
Health Authority: United States: Institutional Review Board

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 April 17, 2014