Hepatic Function in Alcoholics Following 5 Days of Acetaminophen Dosing

February 6, 2009 updated by: Denver Health and Hospital Authority

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

181

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health
  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver CARES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
acetaminophen 4 g/day
Drug: acetaminophen (4g/day)
Placebo Comparator: 2
placebo undistinguishable from active drug
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
group mean aminotransferase measures
mean change in aminotransferase measures between study groups

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Denver Health and Hospital Authority

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

January 24, 2007

First Submitted That Met QC Criteria

January 25, 2007

First Posted (Estimate)

January 26, 2007

Study Record Updates

Last Update Posted (Estimate)

February 9, 2009

Last Update Submitted That Met QC Criteria

February 6, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMIRB #04-0486

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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