CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
acetaminophendrug
Likely dose
acetaminophen 4 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00616018
NCT00616018Phase 4Completed
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Acetaminophen Adduct Formation in Alcohol Abstaining Subjects Administered Therapeutic Doses of Acetaminophen for Ten Consecutive Days

Kennon Heard·interventional·Posted Feb 14, 2008·Updated Jul 12, 2012

In Brief

A Phase 4 clinical trial evaluating acetaminophen for Drug Induced Liver Injury. Completed, enrolled 35 participants across 1 site.

Detailed Summary

Acetaminophen is commonly used to treat fever or pain. Your body clears acetaminophen by processing it in the liver. During the processing, some of the acetaminophen may bind to proteins in the liver. The protein-acetaminophen product is called an "adduct." After a large acetaminophen overdose, the liver has to process a lot of acetaminophen, so large amounts of adducts are formed. However, we have found that lower levels may be formed even when people take recommended doses. The purpose of this study is to measure the amount of adducts formed when healthy people who do not drink alcohol take normal doses of acetaminophen for 10 days.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Induced Liver Injury
CountriesUnited States
CollaboratorsMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 14, 2008
Enrollment StartAug 1, 2007
Primary CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.4 years ago

Interventions

acetaminophendrug

4 g/day for 10 consecutive days