An Efficacy and Safety Study of Two Doses of Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee

Summary

This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Timeline

Start

2013-03-29

Primary completion

2013-08-19

Completion

2013-10

Outcome

Met primary endpoint

paper LMWF-5A resulted in a significant decrease in pain at 12 weeks compared to vehicle control (-0.93 vs -0.72; estimated difference from control: -0.25, p = 0.004); PMID 24498399 ↗

Publications

• Results Bar-Or D, Salottolo KM, Loose H, Phillips MJ, McGrath B, Wei N, Borders JL, Ervin JE, Kivitz A, Hermann M, Shlotzhauer T, Churchill M, Slappey D, Clift V. A randomized clinical trial to evaluate two doses of an intra-articular injection of LMWF-5A in adults with pain due to osteoarthritis of the knee. PLoS One. 2014 Feb 3;9(2):e87910. doi: 10.1371/journal.pone.0087910. eCollection 2014.

Drugs

Indications