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



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 16
Updated:11/30/2013
Start Date:July 2010

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


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.

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 101.0ºF (38.3ºC).

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.
We found this trial at
21
sites
231 E Chestnut St
Louisville, Kentucky 40202
(502) 629-6000
Kosair Children's Hospital For more than a century, Kosair Children's Hospital and its predecessor hospitals...
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Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Durham, NC
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1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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Augusta, Georgia 30909
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Augusta, GA
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Dallas, Texas 75390
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Dallas, TX
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Danbury, Connecticut 06810
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Danbury, CT
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3901 Beaubien St
Detroit, Michigan 48201
(313) 745-5437
Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Detroit, MI
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Memphis, Tennessee 38105
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Montgomery, Alabama 36116
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Montgomery, Alabama 36117
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1514 Jefferson Hwy.
New Orleans, Louisiana 70121
504-842-3000
Ochsner Medical Center Ochsner Medical Center is located near uptown New Orleans and includes acute...
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
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Phoenix, Arizona 85008
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Shreveport, Louisiana
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475 Seaview Ave
Staten Island, New York 10305
(718) 226-9000
Staten Island University Hospital Staten Island University Hospital is a 714-bed, specialized teaching hospital located...
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Tulsa, OK
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Washington DC, District of Columbia 20060
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