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Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

NCT00400621 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-07-08

No results posted yet for this study

Summary

The study objective was to evaluate the safety of ten consecutive days of therapeutic acetaminophen dosing in moderate alcohol consumers. The main outcome was liver injury (measured by an increase in mean serum ALT or AST levels). Patients were randomly assigned to 10 days of acetaminophen or placebo. Blood tests were measured at baseline, day 4 and day 11 to look for injury. We hypothesized that there would be no difference in liver enzymes between the two groups.

Conditions

  • Moderate Alcohol Consumption (1-3 Drinks Per Day)

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

  • Kennon Heard, MD · Rocky Mountain Poison Center

Study Design

Allocation
RANDOMIZED
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Completion
2003-09-30

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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 NCT00400621 on ClinicalTrials.gov