Phase 3
N=118
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Fever
Bottom Line
View on ClinicalTrials.gov: NCT01002573 ↗Enrolled (actual)
118
Serious AEs
4.0%
Results posted
Nov 2016
Primary outcome: Primary: Fever Reduction — -1.5; -0.9 degree Celsius*Time
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ibuprofen (Drug); acetaminophen (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- Cumberland Pharmaceuticals
- Primary completion
- Jun 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fever Reduction |
-1.5; -0.9 | — |
| SECONDARY Change From Baseline in Temperature After the First 30 Minutes of Treatment |
-0.5; -0.3 | — |
| SECONDARY Change From Baseline in Temperature After the First 60 Minutes of Treatment |
-0.9; -0.5 | — |
| SECONDARY Change in Temperature |
-1.5; -0.9 | — |
| SECONDARY Change From Baseline in Temperature After the First Four Hours of Treatment |
-4.4; -2.6 | — |
| SECONDARY Time to Afebrility (in Hours) |
2.2; 3.3 | — |
| SECONDARY Number of Afebrile and Febrile Subject at 4 Hours Post-Dose |
43; 40; 3; 11 | — |
Summary
The primary objective of the study is to determine the superiority of a single dose of intravenous ibuprofen compared to acetaminophen for the treatment of fever during the first two hours of treatment.
Eligibility Criteria
Inclusion Criteria
- Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
- Be between birth (28 weeks to < 40 weeks gestational age) to ≤ 16 years of age.
- Have new (less than 7 days) onset of fever, documented by temperature greater than or equal to 101.0 ºF (38.3 ºC).
Exclusion Criteria
- Have inadequate intravenous access.
- Have received antipyretic drug therapy within 2 hours before dosing.
- Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
- Have received another investigational drug within the past 30 days.
- Be otherwise unsuitable for the study, in the opinion of the Investigator.
- Have a fever due to hyperthermia.
- Pregnant or nursing.
Data sourced from ClinicalTrials.gov (NCT01002573). 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.