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
To Access the Efficacy and Safety of Meloxicam 7.5mg once daily over a treatment period of 56 days
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in pain on active movement assessed by a 100 mm visual analogue scale (100 mm, 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 physical examination (tenderness) | Baseline, 8 weeks after first drug administration |
Not provided
Inclusion Criteria:
- Osteoarthritis of the knee requiring the therapy with non-steroidal anti-inflammatory drugs (NSAIDs)
Exclusion Criteria:
none
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Assessment of significant change from baseline in status according endoscopy | Baseline, 8 weeks after first drug administration |
| Assessment of significant change from baseline in gastrointestinal (GI) symptoms score | Baseline, 8 weeks after first drug administration |
| Assessment of significant change from baseline in laboratory values | Baseline, 8 weeks after first drug administration |
| Number of Patients with Adverse Events | Up to 8 weeks after first drug administration |
| Assessment of significant change from baseline in physical examination (swelling) | Baseline, 8 weeks after treatment |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |