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
Phase of Trial: Phase III
Latest Information Update: 16 Jan 2018
At a glance
- Drugs DMI 9523 (Primary)
- Indications Musculoskeletal pain; Osteoarthritis
- Focus Registrational; Therapeutic Use
- Sponsors Ampio Pharmaceuticals
- 16 Jan 2018 According to an Ampio Pharmaceuticals media release, data from this trial is being discussed in J.P. Morgan Meeting 2018.
- 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.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History