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This clinical trial aims to evaluate and compare the efficacy and safety of Conjuran® and Hyruan in patients with knee osteoarthritis following first and second cycle (repeat) administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conjuran | Experimental | Once a week for 5 injections |
|
| Hyruan | Active Comparator | Once a week for 5 injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conjuran | Device | Once a week for 5 injections |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight-Bearing Pain (WBP) Visual Analog Scale (VAS) | Change from baseline in WBP after the first treatment assessed using a 100-mm Visual Analog Scale (VAS), ranging from 0 to 100. Higher scores indicate worse pain | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight-Bearing Pain (WBP), Resting Pain (RP), and Motion Pain (MP) VAS | Change from baseline in WBP, RP, and MP after the first and second treatment cycles, assessed using a 100-mm VAS (0-100). Higher scores indicate worse pain. | Up to 56 weeks |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Hyruan | Drug | Once a week for 5 injections |
|
|
Change from baseline in WOMAC total and subscale scores after the first and second treatment cycles. WOMAC is a 24-item questionnaire with scores ranging from 0 to 96. Higher scores indicate worse symptoms. |
| Up to 56 weeks |
| EQ-5D (EuroQol 5-Dimension Health Questionnaire) | Change from baseline in EQ-5D score after the first and second treatment cycles. EQ-5D consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and an EQ Visual Analog Scale (EQ VAS; 0-100). Higher scores indicate better health status. | Up to 56 weeks |
| Patient Global Assessment (PGA), Investigator Global Assessment (IGA) | Change from baseline in PGA and IGA after the first and second treatment cycles, assessed using a 100-mm Visual Analog Scale (VAS) (0-100). Higher scores indicate worse disease status. | Up to 56 weeks |
| WBP and OMERACT-OARSI Responder Rate | Proportion of participants meeting WBP responder criteria or OMERACT-OARSI responder criteria | Up to 56 weeks |
| Rescue Medication Use | Proportion (%) of participants using rescue medication and amount of rescue medication consumed. | Up to 56 weeks |
| Incidence of Adverse Events, Laboratory Abnormalities, Vital Sign Abnormalities, and Physical Examination Findings [Safety Evaluation] | Incidence of adverse events, local adverse events, laboratory abnormalities, vital sign abnormalities, and physical examination findings. | Up to 56 weeks |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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