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

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

Assessment of Hepatic Function in Alcoholic Patients Administered Therapeutic Dosing of Acetaminophen- a Multicenter Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

420

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

  • United States
    • Colorado
      • Denver, Colorado, United States, 80204
        • Denver CARES
    • Washington
      • Seattle, Washington, United States, 98122
        • Recovery Centers of King County

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

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mean change in serum aminotransferase levels between study groups

Secondary Outcome Measures

Outcome Measure
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

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

January 1, 2002

Primary Completion

December 6, 2022

Study Completion

July 1, 2004

Study Registration Dates

First Submitted

November 20, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 22, 2006

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 #00-715

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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