Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-002295-17 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to compare a combination of hyaluronic acid and chondroitin sulfate (V0220) to Hyalgan® on pain relief in patients with symptomatic knee osteoarthritis (OA) over 24 weeks when administered in three weekly injections.
Chondroitin sulfate is one of the components of cartilage. Studies have shown that chondroitin sulphate improves the quality of the hyaluronic acid produced in the joint. The benefit of V0220 combination is based on two main physicochemical properties, in line with the characteristics of osteoarthritic disease: optimising the rheological behaviour and improving the buffering effect on synovial flow ("outflow buffering").
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0220 | Experimental |
| |
| Hyaluronan | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chondroitin sulfate and sodium hyaluronate | Device | 3 weekly injections |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pain relief assessed on a global pain Visual Analogic Scale | change from baseline over 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional improvement (questionnaire) | change from baseline over 24 weeks | |
| Patient's and investigator's global assessment of the disease status (Visual Analogic Scale ) | change from baseline over 24 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel MAHEU, Dr | private practice / unaffiliated | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Hyaluronan |
| Drug |
3 weekly injections |
|
|
| Patient's health related quality of life (questionnaire) | over 24 weeks |
| Consumption of analgesic medication (paracetamol and NSAIDs)(number of days and quantity) | over 24 weeks |
| Medico-economic questionnaire | over 24 weeks |
| Occurrence of adverse events | over 24 weeks |
| D012216 |
| Rheumatic Diseases |