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A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Trial Profile

A Multicenter, Randomized, Open-Label, Parallel, Active-Comparator Trial to Determine the Efficacy, Safety, and Pharmacokinetics of Ibuprofen Injection in Pediatric Patients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2019

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At a glance

  • Drugs Ibuprofen (Primary) ; Paracetamol
  • Indications Fever
  • Focus Therapeutic Use
  • Sponsors Cumberland Pharmaceuticals
  • Most Recent Events

    • 07 Feb 2017 According to Cumberland Pharmaceuticals media release, results were published in the British BMC Pediatrics Journal.
    • 23 Nov 2015 Primary endpoint 'Fever Reduction' has been met, according to a Cumberland Pharmaceuticals media release.
    • 23 Nov 2015 According to a Cumberland Pharmaceuticals media release, ibuprofen injection (Caldolor) has been approved for pediatric patients six months of age and older.
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