Phase 4
N=30
Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Pain · Fever
Bottom Line
View on ClinicalTrials.gov: NCT02583399 ↗Enrolled (actual)
30
Serious AEs
4.2%
Results posted
Nov 2020
Primary outcome: Primary: Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. — 75.74 mcg*hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ibuprofen (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
75.74 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
56.28 | — |
| PRIMARY Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
1.30 | — |
| PRIMARY Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes. |
10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Be a hospitalized male or female subject between birth (> 37 weeks gestational age) and < six (6) months of age.
- Have a clinical indication of pain or fever.
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or performance of any study-only related procedures.
Exclusion Criteria
- Have inadequate intravenous access.
- Have an uncorrected ductus dependent congenital heart disease.
- Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory drug or aspirin.
- Have a current history of uncorrected hypovolemia or acute renal disease.
- Have a current history of acute liver disease.
- Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to dosing. Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
Data sourced from ClinicalTrials.gov (NCT02583399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.