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Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:
A Multi-center, Randomized, Double-Blinded, Active-Controlled, Phase II Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis

Clinical Trial Summary

This clinical trial is for patients who have been diagnosed with Kellgren-Lawrence (K&L) Grade 2 or 3 knee osteoarthritis on radiographic examination. Only subjects who voluntarily agree to participate by filling out the written Informed Consent document will undergo screening for subject selection (inclusion/exclusion) criteria, at which time the severity of OA in each knee will be used to determined which knee will be treated (index knee - i.e., the more severely affected knee), and enroll in this study.

Clinical Trial Description

Patients who meet the inclusion/exclusion criteria will be randomly assigned at visit 2 to either of study group 1(low-dose), study group 2 (mid-dose) or active control group at 1:1:1 ratio. Patients will be administered with investigational product. Investigational product will be administered into the to-be-treated (index) knee one time within 7 days after randomization. All patients enrolled will be followed up a total of 6 times (1, 4, 8, 12, 24, and 52 weeks) for up to post-dose 12 months. The patients should visit the study facility according to the visit schedule, and will undergo safety evaluation (vital sign, laboratory test, etc.) and efficacy evaluation [Western Ontario and McMaster Universities osteoarthritis index (WOMAC), 100-mm visual analogue scale (VAS), International Knee Documentation Committee (IKDC) subjective knee evaluation]. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05182034
Study type Interventional
Source Medipost Co Ltd.
Contact Eunyoung Lee
Phone +82234656748
Email ley0113@medi-post.co.kr
Status Recruiting
Phase Phase 2
Start date February 24, 2022
Completion date August 30, 2023
View Details
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