Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 2b, Multicenter, Randomized, Single Blind, Fixed Dose, Parallel Group Study to Evaluate the Efficacy and Safety of Meloxicam SoluMatrix® [Test] Capsules and Meloxicam Tablets in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Conditions
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Osteoarthritis

Intervention / Treatment
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* Drug: Meloxicam Test Capsules
* Drug: Meloxicam Test Capsules
* Drug: Meloxicam Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain Discontinued all analgesic therapy at Screening For women of childbearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control Ability to ambulate Exclusion Criteria: History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam Requires regular (more than 2 doses per week) use of opioid or opioid combination products to control OA pain of the knee or hip Clinically significant unstable cardiac, respiratory, neurological, immunological, hematological, or renal disease Significant difficulties swallowing capsules/tablets or unable to tolerate oral medication Previous participation in another clinical study of Meloxicam Capsules or received any investigational drug or device or investigational therapy within 30 days before Screening

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam low dose test capsule<br>Meloxicam SoluMatrix Capsules - low dose QD | Drug: Meloxicam Test Capsules<br> <br> |
| Experimental: Meloxicam high dose test capsule<br>Meloxicam SoluMatrix Capsules - high dose QD | Drug: Meloxicam Test Capsules<br> <br> |
| Active Comparator: Meloxicam tablets<br>Meloxicam Tablets QD | Drug: Meloxicam Tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |