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NCT00743093 · ClinicalTrials.gov registry record · Phase 4
Aminotransferase Trends During Prolonged Acetaminophen Dosing
A Phase 4 study of Healthy and Drug Toxicity, sponsored by Denver Health and Hospital Authority.
- Completed
- Registry status
- Phase 4
- Development phase
- 398
- Enrollment target
- 2
- Study locations
NCT00743093: Completed Phase 4 study of Healthy and Drug Toxicity, sponsored by Denver Health and Hospital Authority.
NCT00743093 is a Phase 4 study of Healthy and Drug Toxicity that has completed, run by Denver Health and Hospital Authority. The registered enrollment target is 398 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (38% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00743093, a Phase 4 study of Healthy and Drug Toxicity, has completed, sponsored by Denver Health and Hospital Authority.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 398 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16 days will have completed their part of the study. People that develop abnormal liver function tests will continue taking acetaminophen or placebo, and have their liver tests monitored closely for up to an additional 24 days. This is to (1) make sure these tests return to normal and (2) determine when these tests return to normal while still taking acetaminophen or placebo. If at any time the liver tests indicate anything more than a minor increase, you would be immediately told to stop taking the study drug. Secondary objective is to determine the proportion of subjects that have detectable acetaminophen-protein adducts after daily dosing.
Primary Outcome
ALT was measured on Day 0 and 16 for all study participants. Subjects with an elevated ALT at Day 16 continued dosing with study drug and continued to have their ALT measured every three days until the ALT elevation resolved or until Day 40. Persistent ALT elevation was defined as any subject with an unresolved ALT elevation at study Day 40.
Conditions Studied
Interventions
- DRUG placebo
- DRUG acetaminophen
Study Locations (2)
Colorado
- University of Colorado Health Sciences Center - GCRC - Aurora
- Denver Health Rocky Mountain Poison and Drug Center - Denver
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 398 participants |
| Start Date | 2008-08 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT00743093 record still lists
NCT00743093 is an interventional study that assigns participants to a tested intervention. The registered 398 participants enrollment target is mid-sized for trials with a published cap, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (38% lower).
The record links to 2 conditions, with Healthy appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00743093 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT00743093 about?
NCT00743093 is a clinical study titled "Aminotransferase Trends During Prolonged Acetaminophen Dosing". The objective of this study is to monitor liver function tests (blood levels of an indicator of liver function) of healthy people taking the maximum labeled daily dose of acetaminophen compared to people taking placebo for 16 to 40 days. Those people that continue to have normal liver tests after 16...
What is the current status of trial NCT00743093?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 398 participants. The study started on 2008-08. Estimated completion is 2011-08.
What conditions does trial NCT00743093 study?
This clinical trial studies the following conditions: Healthy, Drug Toxicity.
What interventions are being tested in trial NCT00743093?
The interventions under investigation include: placebo (DRUG), acetaminophen (DRUG).
Who is sponsoring clinical trial NCT00743093?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00743093 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
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 NCT00743093's enrollment target sits among peer trials
398 64th of 1090 higher than 1,027 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy 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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