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NCT00493311 · ClinicalTrials.gov registry record · Phase 3
Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
NCT00493311: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT00493311 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00493311, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
Study Summary
A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study.
Primary Outcome
The primary efficacy endpoint was WSTD6 defined as the weighted sum of temperature differences from the temperature at each assessment timepoint through 6 hours compared with the temperature at T0, weighted by the time elapsed between each 2 consecutive timepoints.
Interventions
- DRUG IV Placebo
- DRUG IV Acetaminophen
- BIOLOGICAL Reference Standard Endotoxin (RSE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2007-06 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
What the finished NCT00493311 record still lists
NCT00493311 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 3 interventions - of which IV Placebo is the first listed.
NCT00493311 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00493311 about?
NCT00493311 is a clinical study titled "Safety of Intravenous Acetaminophen Vs Placebo for the Treatment of Endotoxin-Induced Fever in Healthy Adult Males". A research study to determine if acetaminophen (APAP) given intravenously (IV-a liquid given through a needle into a vein in your arm) is safe and effective in controlling fever when compared to placebo. Acetaminophen given this way is the investigational part of this study.
What is the current status of trial NCT00493311?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2007-06. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00493311?
The interventions under investigation include: IV Placebo (DRUG), IV Acetaminophen (DRUG), Reference Standard Endotoxin (RSE) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00493311?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00493311's enrollment target sits among peer trials
60 1804th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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