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

Use our guide to learn which trials are right for you!

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
?
mi
from
Tulsa, OK
Click here to add this to my saved trials
Durham, North Carolina 27710
(919) 684-8111
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
?
mi
from
Durham, NC
Click here to add this to my saved trials
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...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
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...
?
mi
from
Orange, CA
Click here to add this to my saved trials
Augusta, Georgia 30909
?
mi
from
Augusta, GA
Click here to add this to my saved trials
Dallas, Texas 75390
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Danbury, Connecticut 06810
?
mi
from
Danbury, CT
Click here to add this to my saved trials
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...
?
mi
from
Detroit, MI
Click here to add this to my saved trials
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...
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Loma Linda, CA
Click here to add this to my saved trials
Memphis, Tennessee 38105
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Montgomery, Alabama 36116
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
Montgomery, Alabama 36117
?
mi
from
Montgomery, AL
Click here to add this to my saved trials
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...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Florida Hospital Florida Hospital is one of the country
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Phoenix, Arizona 85008
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Shreveport, Louisiana
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
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...
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
Washington DC, District of Columbia 20060
?
mi
from
Washington DC,
Click here to add this to my saved trials