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NCT00564629 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males
A Phase 3 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
NCT00564629: Completed Phase 3 study, sponsored by Mallinckrodt.
NCT00564629 is a Phase 3 study that has completed, run by Mallinckrodt. The registered enrollment target is 105 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00564629, a Phase 3 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
Study Summary
To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever induced by a standard dose of endotoxin
Primary Outcome
This outcome measures when the antipyretic effect begins by statistical analysis of WSTD2, which is the weighted sum of temperature differences from the subject's core temperature at each assessment time point through the first 2 hours compared with the subject's core temperature at T0, weighted by the time elapsed between each 2 consecutive time points. The subject's core temperature was measured using an ingestible temperature monitoring capsule and associated data recorder.
Interventions
- DRUG Intravenous acetaminophen plus oral placebo
- DRUG Oral acetaminophen plus IV placebo
- BIOLOGICAL Reference standard endotoxin (RSE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2007-08 |
| Est. Completion | 2007-10 |
| Phase | Phase 3 |
What the finished NCT00564629 record still lists
NCT00564629 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Intravenous acetaminophen plus oral placebo is the first listed.
NCT00564629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00564629 about?
NCT00564629 is a clinical study titled "Study of the Efficacy and Safety of Intravenous vs Oral Acetaminophen for Treatment of Fever in Healthy Adult Males". To assess the rapidity of onset of antipyretic effect and the efficacy and safety of a single dose of IV acetaminophen (IV APAP) versus oral (PO) acetaminophen in the treatment of fever induced by a standard dose of endotoxin
What is the current status of trial NCT00564629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2007-08. Estimated completion is 2007-10.
What interventions are being tested in trial NCT00564629?
The interventions under investigation include: Intravenous acetaminophen plus oral placebo (DRUG), Oral acetaminophen plus IV placebo (DRUG), Reference standard endotoxin (RSE) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00564629?
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 NCT00564629's enrollment target sits among peer trials
105 1670th of 2000 higher than 330 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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