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To assess the efficacy and safety of meloxicam 7.5mg once daily compared with diclofenac 100mg SR once daily over a treatment period of 8 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam | Experimental |
| |
| Diclofenac | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac | Drug |
| ||
| Meloxicam |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain on active movement assessed by a 100 mm visual analogue Scale (VAS) | Baseline, 8 weeks after first drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Lequesne index | Baseline, 8 weeks after first drug administration | |
| Change from baseline in global assessment by the patient and doctor on a 3-point scale | Baseline, 8 weeks after first drug administration |
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Inclusion Criteria:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria:
- none
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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|
| Number of patients with significant changes from baseline in Laboratory values | Baseline, 8 weeks after first drug administration |
| Number of patients with significant changes from baseline in physical examinations | Baseline, 8 weeks after first drug administration |
| Number of patients with Adverse Events | Up to 8 weeks after first drug administration |
| D013843 |
| Thiazines |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |