Randomized, Multiple-Center, Double-Blind, Placebo-Controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-Operative Pain Following Orthopedic Trauma, Injury, or Surgery.

Trial Profile

Randomized, Multiple-Center, Double-Blind, Placebo-Controlled Study of the Safety and Analgesic Efficacy of Repeated Dosing of PMI-150 (Intranasal Ketamine) to Treat Acute Post-Operative Pain Following Orthopedic Trauma, Injury, or Surgery.

Completed
Phase of Trial: Phase III

Latest Information Update: 06 Apr 2017

At a glance

  • Drugs Ketamine (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Hospira; Javelin Pharmaceuticals
  • Most Recent Events

    • 10 Jan 2012 Actual end date changed from Feb 2009 to Aug 2011 as reported by ClinicalTrials.gov.
    • 12 Feb 2010 Primary endpoint 'Sum of pain intensity difference' has been met, after reexamination of topline data by third party.
    • 12 Aug 2009 Primary endpoint 'Sum of pain intensity difference' has not been met.
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