A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Trial Profile

A Phase 3 Randomized Study to Confirm the Efficacy of an Intra-Articular Injection of Ampion™ in Adults With Pain Due to Severe Osteoarthritis of the Knee

Completed
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2017

At a glance

  • Drugs DMI 9523 (Primary)
  • Indications Musculoskeletal pain; Osteoarthritis
  • Focus Therapeutic Use
  • Sponsors Ampio Pharmaceuticals
  • Most Recent Events

    • 19 Dec 2017 Status changed from active, no longer recruiting to completed.
    • 14 Dec 2017 Primary endpoint evaluate responder status using OMERACT-OARSI scenario D using WOMAC A pain subscore, WOMAC C function subscore, and PGA as composite endpoints; Null Hypothesis: Greater than 30% of patients will be responders has been met.
    • 14 Dec 2017 Results published in the Ampio Pharmaceuticals Media Release.
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