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Internal business decision not to move forward with study
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The purpose of this study is to evaluate the safety and efficacy of a low dose and a high dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain due to osteoarthritis of the knee or hip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Meloxicam low dose test capsule | Experimental | Meloxicam SoluMatrix Capsules - low dose QD |
|
| Meloxicam high dose test capsule | Experimental | Meloxicam SoluMatrix Capsules - high dose QD |
|
| Meloxicam tablets | Active Comparator | Meloxicam Tablets QD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meloxicam Test Capsules | Drug |
| ||
| Meloxicam Test Capsules |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | Baseline to Week 6 | |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured Using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
|---|---|
| D000077239 | Meloxicam |
| ID | Term |
|---|---|
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
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| Drug |
|
| Meloxicam Tablets | Drug |
|
| Baseline to Week 6 |
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Symptoms Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Baseline to Week 6 |
| Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3. | 2 hours after dosing on Day 3 |
| Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14. | 2 hours after dosing on Day 14 |
| Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3. | 2 hours after dosing on Day 3 |
| Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14. | 2 hours after dosing on Day 14 |
| Patient Global Impression of Change | Baseline to Week 6/Early Termination |
| Clinical Global Impression of Change | Baseline to Week 6/Early Termination |
| Amount of Rescue Medication Taken by Each Subject | Baseline to Week 6/Early Termination |
| Cumulative Discontinuations Due to Lack of Efficacy at Week 6 | Baseline to Week 6 |
| Responders with at Least a 10-mm Improvement in Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 6. | Baseline to Week 6 |
| Safety of Meloxicam SoluMatrix Capsules low dose, Meloxicam SoluMatrix Capsules high dose, and Meloxicam Tablets as Assessed by the Incidence of Adverse Events From Baseline to Week 6 or Early Termination | Baseline to Week 6/Early Termination |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |