A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of Two Doses of Intra-Articular Injection of Ampion in Adults With Pain Due to Osteoarthritis of the Knee
Phase of Trial: Phase III
Latest Information Update: 12 Apr 2018
At a glance
- Drugs DMI 9523 (Primary)
- Indications Osteoarthritis
- Focus Registrational; Therapeutic Use
- Acronyms SPRING
- Sponsors Ampio Pharmaceuticals
- 12 Apr 2018 According to an Ampio media release, the Company has begun preliminary discussions with the Food and Drug Administration on details of the Biologics License Application (BLA) submission process for Ampion, a treatment for severe osteoarthritis-of-the-knee. The company is planning to file BLA based on AP-003-A and AP-003-C trials.
- 22 Nov 2017 Pooled analysis of this and 2 other trials (see CT profiles 225451 and 261154) has been published in Orthopedics, according to an Ampio Pharmaceuticals media release.
- 09 Jun 2015 Results published in Stem Cell Translational Medicine on June 3, 2015, according to an Ampio Pharmaceuticals media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History