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NCT02583399 · ClinicalTrials.gov registry record · Phase 4
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
A Phase 4 study, sponsored by Cumberland Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02583399: Completed Phase 4 study, sponsored by Cumberland Pharmaceuticals.
NCT02583399 is a Phase 4 study that has completed, run by Cumberland Pharmaceuticals. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02583399, a Phase 4 study, has completed, sponsored by Cumberland Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
Primary Outcome
This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.
Interventions
- DRUG Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2019-07-02 |
| Phase | Phase 4 |
What the finished NCT02583399 record still lists
NCT02583399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Ibuprofen is the first listed.
NCT02583399 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02583399 about?
NCT02583399 is a clinical study titled "Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients". The primary objective of this study is to evaluate the pharmacokinetic profile of a single dose of intravenous ibuprofen administered over approximately ten (10) minutes.
What is the current status of trial NCT02583399?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2017-08-08. Estimated completion is 2019-07-02.
What interventions are being tested in trial NCT02583399?
The interventions under investigation include: Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT02583399?
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 NCT02583399's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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