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
Phase of Trial: Phase III
Latest Information Update: 03 Jul 2019
At a glance
- Drugs DMI 9523 (Primary)
- Indications Musculoskeletal pain; Osteoarthritis
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms STEP
- Sponsors Ampio Pharmaceuticals
- 22 Nov 2017 Pooled analysis of this and 2 other trials (see CT profiles 214957 and 261154) has been published in Orthopedics, according to an Ampio Pharmaceuticals media release.
- 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.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History