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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021633-31 | EudraCT Number |
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The main objective is the comparison of three different dosage regimens of hyaluronic acid in the treatment of osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hyaluronic acid 5 x 2.5 ml | Active Comparator |
| |
| Hyaluronic acid 1 X 5 ml | Experimental |
| |
| Hyaluronic acid 2 x 5 ml | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hyaluronic acid 5 x 2.5 ml | Drug | 5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The main objective is to evaluate the efficacy of different dosage regimens of intraarticular Hyaluronic Acid 5 ml (Adant®)compared to a standard treatment (2.5ml X 5 i.a) in patients with osteoarthritis of the knee. | Primary endpoint: Pain, Function and patient's assessment according to OARSI 2004 responder criteria. Every patient who has received 100% of injections by the end of the study and has fulfilled the follow-up visits will be considered evaluable. The percentage of patients in each group who do not complete the study due to lack of efficacy will be evaluated. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of the different dosage regimens | Safety endpoints: Recording of adverse events and physical examination | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alejandro Escudero | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Reina Sofia | Córdoba | Andalusia | 14004 | Spain |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Hyaluronic acid 1 x 5 ml | Drug | 1 intraarticular administration of Adant® 5ml |
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| Hyaluronic acid 2 x 5 ml | Drug | 2 intraarticular administration of Adant® 5ml with a two-week interval between administrations. |
|
| D012216 |
| Rheumatic Diseases |