Efficacy and Safety of LBSA0103 Versus Hyruan Plus Injection in Patients With Knee Osteoarthritis

Study Overview
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Brief Summary
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The purpose of this study is to compare efficacy and safety of intra-articular LBSA0103 once versus intra-articular hyaluronic acid injections (Hyruan Plus Injection) once weekly for 3 weeks in the treatment of patients with osteoarthritis of the knee.

Official Title
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An Double-blind, Active-controlled, Parallel-group, Randomized, Multi-center Study to Compare Efficacy and Safety of LBSA0103 Once Versus Hyruan Plus Injection Once Weekly for 3weeks in the Treatment of Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: Placebo
* Drug: Hyruan Plus
* Drug: LBSA0103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 40 years of age Kellgren & Lawrence grade I-III If there is more than one knee having a weight bearing pain of at least 40mm evaluated by 100mm VAS Be willing to discontinue all nonsteroidal anti-inflammatory drugs(NSAIDs), analgesics, condroichin sulfate/glucosamine or physical therapy for the duration of the study Exclusion Criteria: Body mass index > 32 Have rheumarthritis Patients who have a weight-bearing pain of less than 40mm on both knees when measured by 100mm-VAS Have Sudek's atrophy, Paget's disease, Spinal disc herniation Kellgren & Lawrence Grade IV

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: Placebo and then LBSA0103<br>The experimental group receive once weekly for 2 weeks intraarticular injections of Placebo(saline). And then, they receive once intraarticular injections of LBSA0103 into the target knee. | Drug: Placebo<br>* First 2 weeks Placebo(2ml) once weekly in experimental group<br>Drug: LBSA0103<br>* at third week LBSA0103(60mg) once in experimental group<br>|
| Active Comparator: Hyruan Plus<br>The control group received once weekly for 3 weeks intraarticular injections of Hyruan Plus Inj. into the target knee. | Drug: Hyruan Plus<br>* Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-bearing pain | using 100mm-VAS | 12 weeks after the last injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight-bearing pain | using 100mm-VAS | 1,6 weeks after the last injection | 
| WOMAC-likert assessment | Pain, Function, Stiffness, Total score | 1,6,12 weeks after the last injection | 
| Patient Global Assessment | using 100mm-VAS | 1,6,12 weeks after the last injection | 
| Investigator Global Assessment | using 100mm-VAS | 1,6,12 weeks after the last injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoartritis, Knee, LBSA0103, Hyruan Plus Inj.