Clinical trial NCT02583399: Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Fever
Keywords: Pediatric (Birth to less than 6 months of age)
Pain
Fever
Lead sponsor: Cumberland Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multi-center, Open-label
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
timeFrame: 4 hours
measure: Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
timeFrame: 4 hours
measure: Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
timeFrame: 4 hours
measure: Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
timeFrame: 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kosair Charaties Pediatric Research Unit
state: Kentucky
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Dallas
country: United States
facility: Children's Medical Center Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine/Texas Children's Hospital
state: Texas
Study officials:
affiliation: Vanderbilt University
name: Todd Rice, MD
role: STUDY_CHAIR
References: