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Completed

NCT Number: NCT02583399

Safety and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric Patients

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.

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Key information

Conditions

Pain Body Temperature Changes Fever Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kosair Charaties Pediatric Research Unit, Louisville, Kentucky, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ibuprofen

Drug

Ibuprofen, 10 mg/kg

Primary outcomes

  1. Area Under the Curve (AUC) 0-4 Hours of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

    Time frame: 4 hours

    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.

  2. Maximum Observed Plasma Concentration (Cmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

    Time frame: 4 hours

    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.

  3. Elimination Half Life (T 1/2) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

    Time frame: 4 hours

    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. Time to Maximum Concentration (Tmax) of a Single Dose of Intravenous Ibuprofen (IVIb) Administered Over 5-7 Minutes.

    Time frame: 4 hours

    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.

Sponsors and collaborators

Lead sponsor

Cumberland Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 22, 2015
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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