search
Back to results

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

Primary Purpose

Pain, Fever

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ibuprofen
Sponsored by
Cumberland Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pediatric (Birth to less than 6 months of age), Pain, Fever

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kosair Charaties Pediatric Research Unit
  • University of Mississippi Medical Center
  • Children's Medical Center Dallas
  • Baylor College of Medicine/Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ibuprofen

Arm Description

Ibuprofen, 10 mg/kg

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2015
Last Updated
October 28, 2020
Sponsor
Cumberland Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT02583399
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
August 8, 2017 (Actual)
Primary Completion Date
July 2, 2019 (Actual)
Study Completion Date
July 2, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cumberland Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Fever
Keywords
Pediatric (Birth to less than 6 months of age), Pain, Fever

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, Open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ibuprofen
Arm Type
Experimental
Arm Description
Ibuprofen, 10 mg/kg
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Ibuprofen, 10 mg/kg
Primary Outcome Measure Information:
Title
Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Description
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.
Time Frame
4 hours
Title
Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Description
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.
Time Frame
4 hours
Title
Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Description
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.
Time Frame
4 hours
Title
Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.
Description
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.
Time Frame
4 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Rice, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Study Chair
Facility Information:
Facility Name
Kosair Charaties Pediatric Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

We'll reach out to this number within 24 hrs