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COMPLETEDPhase 3NCT01002573

Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

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 treatmen...

Lead sponsor: Cumberland Pharmaceuticals•17 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cumberland Pharmaceuticals

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.

Age

0 - 16 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: November 7, 2016Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment118

Start dateJul 2010

Last updatedNov 7, 2016

Condition

Locations shown

Maricopa Medical Center

Phoenix, Arizona

Loma Linda University Medical Center

Loma Linda, California

Children's Hospital of Orange County

Orange, California

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 7, 2016Data synced to Clareo: May 3, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions