Study of Meloxicam Capsules to Treat Osteoarthritis Pain

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy, and Safety Study of Meloxicam SoluMatrix™ Capsules 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: Placebo Capsules


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of Functional Class I-III OA of the hip or knee Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain Discontinued all analgesic therapy at Screening For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control Exclusion Criteria: History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam Requires continuous 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 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meloxicam Test Capsules low dose QD<br>Meloxicam Test Capsules low dose QD | Drug: Meloxicam Test Capsules<br> <br> |
| Experimental: Meloxicam Test Capsules high dose QD<br>Meloxicam Test Capsules high dose QD | Drug: Meloxicam Test Capsules<br> <br> |
| Placebo Comparator: Placebo Capsule QD<br>Placebo Capsule QD | Drug: Placebo Capsules<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 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain. The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 12/Early Termination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain. The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 2 | 
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain. The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 6 | 
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. | The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing No Pain and 100 mm representing Extreme Pain. The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty. The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline. | Baseline to Week 2 | 
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty. The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline. | Baseline to Week 6 | 
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty. The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. | Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing No Pain, Stiffness, or Difficulty and 100 mm representing Extreme Pain, Stiffness, and Difficulty. The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation. The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 2 | 
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation. The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 6 | 
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation. The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. | The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning No Functional Limitation and 100 mm meaning Extreme Functional Limitation. The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness. The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 2 | 
| Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness. The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 6 | 
| Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness. The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 12/Early Termination | 
| Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. | The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning No Stiffness and 100 mm meaning Extreme Stiffness. The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline. | Baseline to Week 12/Early Termination |