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NCT00606489 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
A Phase 3 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 61
- Enrollment target
NCT00606489: Completed Phase 3 study, sponsored by Cumberland Pharmaceuticals.
NCT00606489 is a Phase 3 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 61 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
NCT00606489, a Phase 3 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 61 participants
- Enrollment target
Study Summary
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
Primary Outcome
Area under the curve temperature from baseline to hour 24 following initiation of treatment.
Interventions
- DRUG Placebo
- DRUG Caldolor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2007-11 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
What the finished NCT00606489 record still lists
NCT00606489 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 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 2 interventions - of which Placebo is the first listed.
NCT00606489 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00606489 about?
NCT00606489 is a clinical study titled "Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients". The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours for at least 24 hours.
What is the current status of trial NCT00606489?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 61 participants. The study started on 2007-11. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00606489?
The interventions under investigation include: Placebo (DRUG), Caldolor (DRUG).
Who is sponsoring clinical trial NCT00606489?
This trial is sponsored by Cumberland Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00606489's enrollment target sits among peer trials
61 1803rd of 2000 higher than 197 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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