Osteoarthritis of Knee
Conditions
Brief summary
A Multi-Centre, Parallel, Double-Blind, Active comparator, Randomised phase III Clinical Trial
Interventions
DRUGHumia inj.
Single injection of 3mL Humia inj. Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks
DRUGHigh hyal Plus inj.
Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
Sponsors
Huons Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline of Weight-bearing pain (100mm-VAS) | Week 14 |
Secondary
| Measure | Time frame |
|---|---|
| Consumption of rescue medication | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 |
| 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 : Range of motion | Weeks 0, 3, 8, 14, 26, and 38 |
| Physical Examination : Tenderness on pressure | Weeks 0,3,8,14,26,and 38 |
| Proportion (%) of patients taking rescue medication | Weeks 0, 1, 2, 3, 8, 14, 26, and 38 |
| Responder Rate | Week 14 |
| Physical Examination : Swelling | Weeks 0, 3, 8, 14, 26, and 38 |
Countries
South Korea
Outcome results
None listed