Effects of Therapeutic Doses of Acetaminophen in Moderate Drinkers

Phase 4

Completed

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

• Registration Number: NCT00400621
• Lead Sponsor: Denver Health and Hospital Authority

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04
• Study Completion: 2003-09
• Status Verified: 2006-11
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
mean change in serum ALT between treatment groups

Secondary Outcome Measures

Name	Time	Method
proportion of patients that developed an abnormal ALT
proportion of patients that developed hepatoxicity (ALT>1000 IU>L)
proportion of patients that developed drug induced liver injury