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

Completed · Phase 3

Conditions studied: Fever

In brief

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.

Key facts

Study ID

NCT01002573

Run by

Cumberland Pharmaceuticals

People needed

118

Starts

2010-07-01

Expected to finish

2013-06-01

Last updated by the study team

2016-11-07

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Maricopa Medical Center — Phoenix, Arizona, United States
• Loma Linda University Medical Center — Loma Linda, California, United States
• Children's Hospital of Orange County — Orange, California, United States
• Howard University — Washington D.C., District of Columbia, United States
• Jackson Memorial Hospital (U. Miami) — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Joseph M. Still Burn Center — Augusta, Georgia, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• LSU Health Sciences Center — Shreveport, Louisiana, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Staten Island University Hospital — Staten Island, New York, United States
• The Children's Hospital at Saint Francis — Tulsa, Oklahoma, United States
• LeBonheur Children's Hospital — Memphis, Tennessee, United States
• Children's Medical Center Dallas — Dallas, Texas, United States
• Children's Memorial Hermann Hospital — Houston, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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