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Study to assess the efficacy and safety of meloxicam suppository 15 mg once daily, meloxicam tablet 15 mg once daily compared with Indomethacin suppository (50 mg daily) in patients with ankylosing spondylitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam suppository | Experimental |
| |
| Meloxicam tablet | Experimental |
| |
| Indomethacin suppository | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam suppository | Drug |
| ||
| Meloxicam tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Overall pain during the previous 48 hours assessed on a Visual Analogue Scale (VAS) | 6 weeks | |
| Functional Index of ankylosing spondylitis of Dougados | 6 weeks | |
| Overall assessment of disease activity by the patient on VAS | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall assessment of disease activity by the investigator on a VAS | 6 weeks | |
| Global efficacy assessed by the patient (verbal rating scale) | 6 weeks | |
| Global efficacy assessed by the investigator (verbal rating scale) |
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Inclusion Criteria:
Exclusion Criteria:
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|
| Indomethacin | Drug |
|
| 6 weeks |
| Duration of morning stiffness | 6 weeks |
| Evaluation of spinal pain by the investigator (verbal rating scale) | 6 weeks |
| Assessment of Schober test | 6 weeks |
| Assessment of Chest expansion | 6 weeks |
| Assessment of Fingers - to - floor test | 6 weeks |
| Assessment of Night pain (verbal rating scale) | 6 weeks |
| Total number of study withdrawals | 6 weeks |
| Number of study withdrawals due to lack of efficacy | 6 weeks |
| Assessment of Paracetamol consumption | 6 weeks |
| Assessment of Patient status with regard to disease condition | 6 weeks |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000077239 | Meloxicam |
| D007213 | Indomethacin |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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