A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Cumberland Pharmaceuticals17 sites in 1 country118 target enrollmentJuly 2010

ConditionsFever

Interventionsibuprofen acetaminophen

Drugsibuprofen acetaminophen

Overview

Phase: Phase 3
Intervention: ibuprofen
Conditions: Fever
Sponsor: Cumberland Pharmaceuticals
Enrollment: 118
Locations: 17
Primary Endpoint: Fever Reduction
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Detailed Description

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 as measured by the area under the change in temperature versus time curve during the first 2 hours of treatment.

Registry

clinicaltrials.gov

Start Date

July 2010

End Date

June 2013

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Cumberland Pharmaceuticals

Responsible Party

Sponsor

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.

Arms & Interventions

ibuprofen

Ibuprofen, 10 mg/kg

Intervention: ibuprofen

Acetaminophen

Acetaminophen, 10mg/kg

Intervention: acetaminophen

Outcomes

Primary Outcomes

Fever Reduction

Time Frame: 0 to 2 hours post-dose

Treatment of fever as measured by the area under the change in temperature versus time curve during the first two hours of treatment (AUC0-2)

Secondary Outcomes

Change From Baseline in Temperature After the First Four Hours of Treatment(0 to 4 hours post-dose)
Change From Baseline in Temperature After the First 30 Minutes of Treatment(30 minutes following treatment)
Change From Baseline in Temperature After the First 60 Minutes of Treatment(60 minutes following treatment)
Time to Afebrility (in Hours)(4 Hour post treatment)
Change in Temperature(4 hours following treatment)
Number of Afebrile and Febrile Subject at 4 Hours Post-Dose(4 Hours Post-Dose)