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

NCT00402571 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2009-02-09

No results posted yet for this study

Summary

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.

Conditions

  • Alcohol Related Disorders

Interventions

DRUG

acetaminophen

Sponsors & Collaborators

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    collaborator INDUSTRY

  • Denver Health and Hospital Authority

    lead OTHER

Principal Investigators

  • Richard C Dart, MD, PhD · Denver Health/Rocky Mountain Poison & Drug Center

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2002-01-31
Completion
2004-07-31

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00402571 on ClinicalTrials.gov