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NCT00470600 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients
A Phase 3 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 185
- Enrollment target
NCT00470600: Completed Phase 3 study, sponsored by Cumberland Pharmaceuticals.
NCT00470600 is a Phase 3 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 185 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00470600, a Phase 3 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 185 participants
- Enrollment target
Study Summary
The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients self-assessment of pain.
Primary Outcome
Measurement of the patient's self assessment of pain with movement using the validated visual analog scale (VAS) during the post-operative period (study hour-6 through hour-28). VAS assessments document the patient's self reported level of pain from "No pain" (0 mm) to "Worst possible pain" (100 mm) on a 100 mm line. VAS assessments were performed immediately following surgery \[variable since every surgery has a unique length of time even if it is the same procedure\] and at hours 6, 8, 12, 16,
Interventions
- OTHER Normal Saline
- DRUG Caldolor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-09 |
| Phase | Phase 3 |
What the finished NCT00470600 record still lists
NCT00470600 is an interventional study that assigns participants to a tested intervention. The registered 185 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 (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Normal Saline is the first listed.
NCT00470600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00470600 about?
NCT00470600 is a clinical study titled "Efficacy and Safety Study of Caldolor (IV Ibuprofen) in Hospitalized Adult Orthopedic Patients". The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative hospitalized adult orthopedic patients every 6 hours for at least 24 hours is to determine the efficacy of Caldolor (IV ibuprofen) compared to placebo for the treatment of post-operative pain by patients se...
What is the current status of trial NCT00470600?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 185 participants. The study started on 2007-05. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00470600?
The interventions under investigation include: Normal Saline (OTHER), Caldolor (DRUG).
Who is sponsoring clinical trial NCT00470600?
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 NCT00470600's enrollment target sits among peer trials
185 1417th of 2000 higher than 583 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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