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

NCT06307847 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 223

Last updated 2024-03-13

No results posted yet for this study

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

DRUG

SP5M001 inj

pre-filled syringe

DRUG

Synovian inj

pre-filled syringe

Sponsors & Collaborators

  • Shin Poong Pharmaceutical Co. Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2022-10-25
Completion
2022-10-25

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06307847 on ClinicalTrials.gov