Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Completed · Phase 4

Conditions studied: Pain, Fever

In brief

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.

Key facts

Study ID: NCT02583399
Run by: Cumberland Pharmaceuticals
People needed: 30
Starts: 2017-08-08
Expected to finish: 2019-07-02
Last updated by the study team: 2020-11-20

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Kosair Charaties Pediatric Research Unit — Louisville, Kentucky, United States
University of Mississippi Medical Center — Jackson, Mississippi, United States
Children's Medical Center Dallas — Dallas, Texas, United States
Baylor College of Medicine/Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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