Status:
COMPLETED
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Lead Sponsor:
Cumberland Pharmaceuticals
Conditions:
Fever
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE3
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 treatmen...
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 chan...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01002573
Start Date
July 1 2010
End Date
June 1 2013
Last Update
November 7 2016
Active Locations (17)
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1
Maricopa Medical Center
Phoenix, Arizona, United States, 85008
2
Loma Linda University Medical Center
Loma Linda, California, United States, 92354
3
Children's Hospital of Orange County
Orange, California, United States, 92868
4
Howard University
Washington D.C., District of Columbia, United States, 20060