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A Phase IIIB Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

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Trial Profile

A Phase IIIB Multi-Center, Open-Label, Prospective, Repeated Dose, Multi-Day Study of the Safety & Efficacy of Intravenous Acetaminophen in Pediatric Inpatients

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 16 May 2017

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At a glance

  • Drugs Paracetamol (Primary)
  • Indications Acute pain; Fever
  • Focus Adverse reactions; Registrational
  • Sponsors Cadence Pharmaceuticals

    • Most Recent Events

    • 02 Nov 2010 According to a Cadence Pharmaceuticals media release, the US FDA has approved OFIRMEV (IV parcetamol) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
    • 19 Jan 2009 Status changed from active, no longer recruiting to completed.
    • 17 Dec 2008 Results are expected in the first quarter of 2009.

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