Clinical trial NCT01002573: Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Official title: A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fever
Keywords: Pediatric
Fever
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-10-27
Enrollment: 118
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Have written informed consent provided by legal parent, guardian, or authorized agent prior to participation in the study or study-only related procedures.
2. Be between birth (28 weeks to \< 40 weeks gestational age) to ≤ 16 years of age.
3. 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:

1. Have inadequate intravenous access.
2. Have received antipyretic drug therapy within 2 hours before dosing.
3. Have any history of allergy or hypersensitivity to NSAIDs or aspirin.
4. Have received another investigational drug within the past 30 days.
5. Be otherwise unsuitable for the study, in the opinion of the Investigator.
6. Have a fever due to hyperthermia.
7. Pregnant or nursing.

Primary outcomes:
measure: Fever Reduction
timeFrame: 0 to 2 hours post-dose
Secondary outcomes:
measure: Change From Baseline in Temperature After the First 30 Minutes of Treatment
timeFrame: 30 minutes following treatment
measure: Change From Baseline in Temperature After the First 60 Minutes of Treatment
timeFrame: 60 minutes following treatment
measure: Change in Temperature
timeFrame: 4 hours following treatment
measure: Change From Baseline in Temperature After the First Four Hours of Treatment
timeFrame: 0 to 4 hours post-dose
measure: Time to Afebrility (in Hours)
timeFrame: 4 Hour post treatment
measure: Number of Afebrile and Febrile Subject at 4 Hours Post-Dose
timeFrame: 4 Hours Post-Dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Maricopa Medical Center
state: Arizona
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Orange
country: United States
facility: Children's Hospital of Orange County
state: California
city: Washington DC
country: United States
facility: Howard University
state: District of Columbia
city: Miami
country: United States
facility: Jackson Memorial Hospital (U. Miami)
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Augusta
country: United States
facility: Joseph M. Still Burn Center
state: Georgia
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Detroit
country: United States
facility: Children's Hospital of Michigan
state: Michigan
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Tulsa
country: United States
facility: The Children's Hospital at Saint Francis
state: Oklahoma
city: Memphis
country: United States
facility: LeBonheur Children's Hospital
state: Tennessee
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Children's Memorial Hermann Hospital
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
affiliation: Cumberland Pharmaceuticals, Inc.
name: Art Wheeler, M.D.
role: STUDY_DIRECTOR
References:
citation: Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.