A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of AmpionTM (<5 Kilodalton Ultrafiltrate of 5% Human Serum Albumin) in Adults With Pain Due to Osteoarthritis (OA) of the Knee

Trial Profile

A Phase 3 Randomized, Placebo-controlled, Double-blind Study to Evaluate the Safety and Efficacy of a Single Intra-articular Injection of AmpionTM (<5 Kilodalton Ultrafiltrate of 5% Human Serum Albumin) in Adults With Pain Due to Osteoarthritis (OA) of the Knee

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2016

At a glance

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

    • 05 Jun 2015 According to an Ampio Pharmaceutical media release, the investigation focuses on whether the company and its executives violated federal securities laws by failing to disclose that the clinical research organization conducting the STEP study lacked autonomy and the trial drug supply for the STEP study was shipped to clinical sites at lower temperatures than were permitted by the drugs specifications. As a result of the company fraudulent conduct investors have been severely damaged.
    • 05 Jun 2015 According to an Ampio Pharmaceutical media release, Law offices of Howard G.Smith is investigating potential claim on behalf of investors Ampio pharmaceuticals.
    • 17 Sep 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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