Pivotal Study to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis

Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
This is a randomized, double‐blind, multicenter, non��inferiority, pivotal clinical trial to assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross‐linked hyaluronate intra‐articular injection (SP5M001) compared with an active comparator, the 1,4‐butanediol diglycidyl ether (BDDE) cross‐linked hyaluronate (Synovian) in patients with knee osteoarthritis.
Epistemonikos ID: 9ccbfed9d7597f1bf6ea5ae0b95b3f424181e13e
First added on: May 15, 2024