Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Trial Profile

Prospective, Multi-Center, Randomized, Open-Label, Single and Repeated Dose, 48 Hour Study, of Intravenous Acetaminophen in Pediatric Inpatients to Determine Pharmacokinetics (PK) and Safety in Acute Pain and Fever

Completed
Phase of Trial: Phase I

Latest Information Update: 18 Jun 2015

At a glance

  • Drugs Paracetamol (Primary)
  • Indications Acute pain
  • Focus Pharmacokinetics
  • Sponsors Cadence Pharmaceuticals
  • Most Recent Events

    • 28 Dec 2010 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 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.
    • 17 Dec 2008 Pharmacokinetic and safety results announced in a Cadence Pharmaceuticals media release.
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