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A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

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Trial Profile

A Phase 3, Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Placebo-Controlled Study of Indomethacin Nanoformulation Capsules for the Treatment of Acute Postoperative Pain After Bunionectomy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Apr 2015

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At a glance

  • Drugs Indometacin (Primary)
  • Indications Postoperative pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Iroko Pharmaceuticals

    • Most Recent Events

    • 03 May 2014 Results of sensitivity analyses on the primary endpoint results presented at the 33rd Annual Scientific Meeting of the American Pain Society.
    • 30 Oct 2013 Primary endpoint 'Pain-intensity-difference' has been met according to results presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.
    • 30 Oct 2013 Results presented at the 77th American College of Rheumatology and the 48th Annual Meeting of the Association of Rheumatology and Health Professionals.

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