A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Trial Profile

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy and Safety Study of Diclofenac [Test] Capsules in Subjects With Osteoarthritis of the Knee or Hip

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Jun 2016

At a glance

  • Drugs Diclofenac (Primary)
  • Indications Musculoskeletal pain; Osteoarthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Iroko Pharmaceuticals
  • Most Recent Events

    • 23 Jun 2016 Results published in an Iroko Pharmaceuticals media release.
    • 25 Aug 2014 Diclofenac [ZOROVOLEX] was approved by the US FDA for the management of osteoarthritis pain based on data from this trial and its extension study, according to an Iroko Pharmaceuticals media release.
    • 29 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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