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Pivotal Study to Evaluate Efficacy and Safety of SP5M002 Inj. as Compared to Synovian Inj. in Patients With Mild to Moderate Knee Osteoarthritis - Trial NCT06399042

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.

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NCT06399042
Phase 3
Recruitment Completed
Device Trial
device
Trial Details
ClinicalTrials.gov • NCT06399042
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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

Study Focus

Osteoarthritis

SP5M002 inj

Interventional

device

Sponsor & Location

Shin Poong Pharmaceutical Co. Ltd.

Daegu,Daegu,Gwangju,Incheon,Jeonju,Jinju,Sejong,Seongnam,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul,Seoul, South Korea

Timeline & Enrollment

Phase 3

Jun 14, 2023

Sep 01, 2024

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 osteoarthropathy
Other specified osteochondropathies
Polyarthritis, unspecified
Other osteochondropathies
Osteochondritis dissecans

Data Source

ClinicalTrials.gov

NCT06399042

Device Trial