Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Public ClinicalTrials.gov record NCT02583399. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months
Study identification
- NCT ID
- NCT02583399
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Lead sponsor
- Cumberland Pharmaceuticals
- Industry
- Enrollment
- 30 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- Up to 6 Months
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 7, 2017
- Primary completion
- Jul 1, 2019
- Completion
- Jul 1, 2019
- Last update posted
- Nov 19, 2020
2017 – 2019
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Kosair Charaties Pediatric Research Unit | Louisville | Kentucky | 40202 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| Baylor College of Medicine/Texas Children's Hospital | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02583399, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 19, 2020 · Synced Jul 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02583399 live on ClinicalTrials.gov.