Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

NCT02583399 | Completed Phase 4 Results FDA Drug

• 1 other identifier: CPI-CL-022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 4

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.

Conditions

Pain; Fever

Keywords

Pediatric (Birth to less than 6 months of age); Pain; Fever

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

Ibuprofen

EXPERIMENTAL

Ibuprofen, 10 mg/kg

Drug: Ibuprofen

Interventions

Ibuprofen DRUG

Ibuprofen, 10 mg/kg

Ibuprofen

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Cumberland Pharmaceuticals: lead

Study Sites (4)

Kosair Charaties Pediatric Research Unit

Louisville, Kentucky, 40202, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Glover CD, Berkenbosch JW, Taylor MB, Patel NV, Kaelin B, Gibson BHY, Zhong J. A Multi-Center Evaluation of the Pharmacokinetics and Safety of Intravenous Ibuprofen in Infants 1-6 Months of Age. Paediatr Drugs. 2023 Sep;25(5):585-593. doi: 10.1007/s40272-023-00576-9. Epub 2023 Jun 9.

  PMID: 37294477 DERIVED

MeSH Terms

Conditions

Pain; Fever

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Temperature Changes

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Sr. Manager, Clinical Operations
• Organization: Cumberland Pharmaceuticals Inc.

bkaelin@cumberlandpharma.com

615-255-0068

Study Officials

• Todd Rice, MD

  Vanderbilt University

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, Open-label

Study Record Dates

• First Submitted: October 20, 2015
• First Posted: October 22, 2015
• Study Start: August 8, 2017
• Primary Completion: July 2, 2019
• Study Completion: July 2, 2019
• Last Updated: November 20, 2020
• Results First Posted: November 20, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)