A Study to Evaluate the Safety and Efficacy of Humia Inj. in Patients With Symptomatic Osteoarthritis of the Knee

Study Overview
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Brief Summary
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A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial

Conditions
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Osteoarthritis of Knee

Intervention / Treatment
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* Drug: Humia inj.
* Drug: High hyal Plus inj.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary knee osteoarthritis confirmed clinically and radiologically according to American College of Rheumatology criteria have joint pain Kellgren-Lawrence Grade Ⅰ to Ⅲ confirmed radiologically within 6 months Knee pain under weight-bearing pain(100mm-VAS) greater than 40mm Able to walk without assistive devices Patients willing and able to provide signed informed consent after the nature of the study has been explained Exclusion criteria: Body Mass Index (BMI) > 32 History of rheumatoid arthritis or other inflammatory arthritis in knee articular cavity Systemic Intravenous Steroid injection within 1 month, intra-articular corticosteroid injection within 3 months or hyaluronate injection within 6 months Has clinically severe tense effusion of the target knee diagnosed Positive according to Patella tap test Undergo Knee Replacement Surgery of the target knee

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Humia inj.<br>Participants with symptomatic Primary Osteoarthritis of Knee received a single injection of 3ml Humia inj. | Drug: Humia inj.<br>* Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks<br>|
| Active Comparator: High Hyal Plus inj.<br>Participants (Control Group) with symptomatic Primary Osteoarthritis of Knee received single injection of 2ml High Hyal Plus inj. given weekly for 3 weeks | Drug: High hyal Plus inj.<br>* Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Weight-bearing pain (100mm-VAS) |  | Week 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Weight-bearing pain (100mm-VAS) |  | Weeks 3, 8, 14, and 26 | 
| Change from Visit 8 of Weight-bearing pain (100mm-VAS) |  | Week 38 | 
| Physical Examination : Swelling |  | Weeks 0, 3, 8, 14, 26, and 38 | 
| Physical Examination : Tenderness on pressure |  | Weeks 0,3,8,14,26,and 38 | 
| Physical Examination : Range of motion |  | Weeks 0, 3, 8, 14, 26, and 38 | 
| Consumption of rescue medication |  | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 | 
| Proportion (%) of patients taking rescue medication |  | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 | 
| Responder Rate |  | Week 14 |