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NCT06399042Recruitment Completed

Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis

A Multi-center, Randomized, Double-Blinded, Active Controlled, Phase III Study to Evaluate Efficacy and Safety of SP5M002 Injection Compared With Synovian Injection in Patients With Mild to Moderate Knee Osteoarthritis
Shin Poong Pharmaceutical Co. Ltd.Phase 3ClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Osteoarthritis
Drug/Device/Intervention
SP5M002 inj
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Shin Poong Pharmaceutical Co. Ltd.
Location
Daegu,Daegu,Gwangju,Incheon,Jeonju,Jinju,Sejong,Seongnam,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul, South Korea
Timeline & enrollment
Phase
Phase 3
Start date
Jun 14, 2023
End date
Sep 01, 2024
Enrollment
297 participants
Primary outcome

Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 12 from baseline (visit 2),Change in [Weight-Bearing Pain (WBP)-100mm-visual analogue scale (VAS)] at Week 6 from baseline (visit 2)

Summary

This is a randomized, double-blind, multicenter, Active Controlled, pivotal clinical trial to
 assess the efficacy and safety of the novel hexamethylenediamine (HMDA) cross-linked
 hyaluronate intra-articular injection (SP5M002) compared with an active comparator, the
 1,4-butanediol diglycidyl ether (BDDE) cross-linked hyaluronate (Synovian) in patients with
 knee osteoarthritis.

ICD-10 classifications
Other hypertrophic osteoarthropathyOther specified osteochondropathiesPolyarthritis, unspecifiedOther osteochondropathiesOsteochondritis dissecans
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06399042
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06399042 through Pure Global AI's free database. This Phase 3 trial is sponsored by Shin Poong Pharmaceutical Co. Ltd. and is currently Recruitment Completed. The study focuses on Osteoarthritis. Target enrollment is 297 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.