Status:
COMPLETED
To Assess the Safety and Effectiveness of Hyruan ONE Versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Lead Sponsor:
LG Chem
Conditions:
Osteoarthritis (OA) of the Knee
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
To Assess the Safety and Effectiveness of Hyruan ONE versus a Comparator for the Treatment of Knee Osteoarthritis in Europe
Eligibility Criteria
Inclusion
- Subject is ≥40 years old.
- Subject has radiographic evidence of mild-to-moderate OA (Kellgren Lawrence Scale grade II III) in one or both knees. Radiographs to be taken within 12 months prior to the Screening visit.
- Subject has OA pain in the target knee despite conservative physical treatments and/or analgesics.
Exclusion
- Subject has rheumatoid arthritis or other inflammatory metabolic arthritis.
- Subject has a documented history of hypersensitivity to HA.
- Subject has a documented infection or severe inflammation of the target knee joint.
- Subject has a skin disease in the area of the injection site.
- Subject has a clinically apparently tense effusion of the target knee on examination determined by either a positive bulge sign or positive ballottement of the patella (patellar tap).
- Subject has chronic pain requiring chronic ongoing analgesic therapy that confounds the measurement of pain in the target knee.
Key Trial Info
Start Date :
February 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2021
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT04732793
Start Date
February 3 2021
End Date
December 7 2021
Last Update
March 16 2022
Active Locations (1)
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1
Lubelskie Centrum Diagnostyczne
Świdnik, Poland, 21-040