Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

Summary

The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.

Timeline

Start

2011-12

Primary completion

2012-03

Completion

2012-10

Outcome

Met primary endpoint

paper proving non-inferiority of XLHA to HMWHA as the lower bound of 95% CI (-1.9 mm, 10.1 mm) was well above the predefined margin (-10 mm). PMID 28549436 ↗

Publications

• Ha CW, Park YB, Choi CH, Kyung HS, Lee JH, Yoo JD, Yoo JH, Choi CH, Kim CW, Kim HC, Oh KJ, Bin SI, Lee MC. Efficacy and safety of single injection of cross-linked sodium hyaluronate vs. three injections of high molecular weight sodium hyaluronate for osteoarthritis of the knee: a double-blind, randomized, multi-center, non-inferiority study. BMC Musculoskelet Disord. 2017 May 26;18(1):223. doi: 10.1186/s12891-017-1591-4.

Drugs

Indications