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NCT00616018 · ClinicalTrials.gov registry record · Phase 4

Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days

A Phase 4 study of Drug Induced Liver Injury, sponsored by Kennon Heard.

Completed
Registry status
Phase 4
Development phase
35
Enrollment target
1
Study location

NCT00616018 is a Phase 4 study of Drug Induced Liver Injury that has completed, run by Kennon Heard. The registered enrollment target is 35 participants. The trial reports 1 study location across 1 state.

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The verdict

NCT00616018, a Phase 4 study of Drug Induced Liver Injury, has completed, sponsored by Kennon Heard.

COMPLETED
Registry status
Phase 4
Development phase
35 participants
Enrollment target
1
Study location

Study 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.

Conditions Studied

Interventions

  • DRUG acetaminophen

Study Locations (1)

Colorado

  • Denver Health Rocky Mountain Poison and Drug Center - Denver

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2007-08
Est. Completion 2008-01
Phase Phase 4

Sponsor

Kennon Heard

1 total trials

What the Registry Record Tells You About NCT00616018

The ClinicalTrials.gov registry entry for NCT00616018 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kennon Heard, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Drug Induced Liver Injury appearing as the primary indexed condition, and to 1 intervention - of which acetaminophen is the first listed.

NCT00616018 reports 1 study location spanning 1 distinct geographic area - top geographies include Colorado.

Frequently Asked Questions

What is clinical trial NCT00616018 about?

NCT00616018 is a clinical study titled "Acetaminophen Adduct Formation in Non-Drinkers Taking Therapeutic Doses of Acetaminophen for Ten Consecutive Days". 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 ...

What is the current status of trial NCT00616018?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2007-08. Estimated completion is 2008-01.

What conditions does trial NCT00616018 study?

This clinical trial studies the following conditions: Drug Induced Liver Injury.

What interventions are being tested in trial NCT00616018?

The interventions under investigation include: acetaminophen (DRUG).

Who is sponsoring clinical trial NCT00616018?

This trial is sponsored by Kennon Heard, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00616018 being conducted?

This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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