NCT06307847

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

A Multi-center, Randomized, Double-Blinded, Active Controlled, Non-Inferiority, Phase III Clinical Trial to Evaluate Efficacy and Safety of SP5M001 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 223 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoarthritis Thumb

Interventions

Type	Name	Description
DRUG	SP5M001 inj	pre-filled syringe
DRUG	Synovian inj	pre-filled syringe

Timeline

• Start date: 2021-04-14
• Primary completion: 2022-10-25
• Completion: 2022-10-25
• First posted: 2024-03-13
• Last updated: 2024-03-13

Locations

14 sites across 1 country: South Korea