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A clinical study of Ampion for the treatment of severe osteoarthritis of the knee (OAK)

Trial Profile

A clinical study of Ampion for the treatment of severe osteoarthritis of the knee (OAK)

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 27 Dec 2018

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At a glance

  • Drugs DMI 9523 (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 27 Dec 2018 New trial record
  • 13 Dec 2018 According to an Ampio Pharmaceuticals media release, the company will be filing the SPA submission in the near future. The trial is designed to expand by 150 patients (300 total patients) if necessary.
  • 13 Dec 2018 According to an Ampio Pharmaceuticals media release, the US FDA's Office of Tissue and Advanced Therapies (OTAT) has provided final guidance that the company should complete an additional trial of KL4 osteoarthritis patients with concurrent controls that would be carried out under a SPA.

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