Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583399
• Other study ID #: CPI-CL-022
• Status: Completed
• Phase: Phase 4
• Start date: August 8, 2017
• Est. completion date: July 2, 2019

Study information

• Verified date: October 2020
• Source: Cumberland Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2, 2019
• Est. primary completion date: July 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Fever
• Pain

Intervention

Drug:
• Ibuprofen
Ibuprofen, 10 mg/kg

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Cumberland Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.	This outcome measurement was to the determine the area under the plot of plasma concentrations of drug against time after drug administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.	4 hours
Primary	Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.	This outcome measurement was to measure the maximal or peak measured serum concentration (Cmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.	4 hours
Primary	Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.	This outcome measurement was to determine the half-life or the period of time required for the concentration or amount of drug in the body to be reduced to exactly one-half of a given concentration or amount. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.	4 hours
Primary	Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.	This outcome measurement was to determine the time to maximum concentration (Tmax) of a single dose of intravenous ibuprofen (IVIb) after its administration. Pharmacokinetic samples were collected immediately following the first dose, the utilizing sparse sampling techniques, samples were collected at 30 minutes, 1 hour, 2 hours and 4 hours.	4 hours