Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients



Status:Recruiting
Conditions:Chronic Pain, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Musculoskeletal
Healthy:No
Age Range:Any
Updated:12/26/2018
Start Date:July 17, 2017
End Date:December 2019
Contact:Byron Kaelin
Email:bkaelin@cumberlandpharma.com
Phone:615-255-0068

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A Multi-Center, Open-Label Pharmacokinetic and Safety Study for Reduction in Fever or Management of Pain in Pediatric Subjects Aged Birth to Six Months

The primary objective of this study is to evaluate the pharmacokinetic profile of a single
dose of intravenous ibuprofen administered over approximately ten (10) minutes.

The primary objective of this study is to evaluate the pharmacokinetic profile of a single
dose of intravenous ibuprofen administered over approximately ten (10) minutes.

Inclusion Criteria:

- Be a hospitalized male or female subject between birth (> 37 weeks gestational age)
and < six (6) months of age.

- Have a clinical indication of pain or fever.

- Have written informed consent provided by legal parent, guardian, or authorized agent
prior to participation in the study or performance of any study-only related
procedures.

Exclusion Criteria:

- Have inadequate intravenous access.

- Have an uncorrected ductus dependent congenital heart disease.

- Have any history of allergy or hypersensitivity to non-steroidal anti-inflammatory
drug or aspirin.

- Have a current history of uncorrected hypovolemia or acute renal disease.

- Have a current history of acute liver disease.

- Have received NSAID, acetaminophen, or aspirin drug therapy within four hours prior to
dosing. Have received another investigational drug within the past 30 days.

- Be otherwise unsuitable for the study, in the opinion of the Investigator.
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Mary Taylor, MD
Phone: 601-815-9480
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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1935 Medical District Dr
Dallas, Texas 75235
(214) 456-7000
Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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Dallas, TX
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1100 East Market Street
Louisville, Kentucky 40202
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Louisville, KY
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