Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
NCT ID: NCT01002573
Last Updated: 2016-11-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
118 participants
INTERVENTIONAL
2010-07-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ibuprofen
Ibuprofen, 10 mg/kg
ibuprofen
Ibuprofen, 10 mg/kg
Acetaminophen
Acetaminophen, 10mg/kg
acetaminophen
Acetaminophen, 10mg/kg
Interventions
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ibuprofen
Ibuprofen, 10 mg/kg
acetaminophen
Acetaminophen, 10mg/kg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
16 Years
ALL
No
Sponsors
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Cumberland Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Art Wheeler, M.D.
Role: STUDY_DIRECTOR
Cumberland Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Khalil SN, Hahn BJ, Chumpitazi CE, Rock AD, Kaelin BA, Macias CG. A multicenter, randomized, open-label, active-comparator trial to determine the efficacy, safety, and pharmacokinetics of intravenous ibuprofen for treatment of fever in hospitalized pediatric patients. BMC Pediatr. 2017 Feb 1;17(1):42. doi: 10.1186/s12887-017-0795-y.
Other Identifiers
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CPI-CL-012
Identifier Type: -
Identifier Source: org_study_id