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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: Completed Phase 4 study of Drug Induced Liver Injury, sponsored by Kennon Heard.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Acetaminophen-cysteine (APAP-Cys) protein adduct concentrations were measured at Day 0, 4, 7, 9, 11 and 14. All units are in nmol/mL serum.
Conditions Studied
Interventions
- DRUG acetaminophen
Study Locations (1)
Colorado
- Denver Health Rocky Mountain Poison and Drug Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2007-08 |
| Est. Completion | 2008-01 |
| Phase | Phase 4 |
What the finished NCT00616018 record still lists
NCT00616018 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Drug Induced Liver Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00616018's enrollment target sits among peer trials
35 1506th of 2000 higher than 482 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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