Study of Meloxicam Capsules to Treat Osteoarthritis Pain
- Conditions
- Osteoarthritis
- Interventions
- Drug: Placebo Capsules
- Registration Number
- NCT01787188
- Lead Sponsor
- Iroko Pharmaceuticals, LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 403
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meloxicam Test Capsules low dose QD Meloxicam Test Capsules Meloxicam Test Capsules low dose QD Meloxicam Test Capsules high dose QD Meloxicam Test Capsules Meloxicam Test Capsules high dose QD Placebo Capsule QD Placebo Capsules Placebo Capsule QD
- Primary Outcome Measures
Name Time Method 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. Baseline to Week 12/Early Termination 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.
- Secondary Outcome Measures
Name Time Method 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. Baseline to Week 2 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.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. Baseline to Week 6 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 6 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 2 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.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. Baseline to Week 6 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.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. Baseline to Week 12/Early Termination 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.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. Baseline to Week 2 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.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. Baseline to Week 6 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.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. Baseline to Week 2 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.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. Baseline to Week 12/Early Termination 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.
Trial Locations
- Locations (37)
Office of Matthew Barton, MD
🇺🇸Las Vegas, Nevada, United States
Sterling Research Group, Ltd
🇺🇸Cincinnati, Ohio, United States
Community Research - Anderson
🇺🇸Cincinnati, Ohio, United States
Radiant Research, Inc
🇺🇸Anderson, South Carolina, United States
Clinical Trials Technology Inc
🇺🇸Prairie Village, Kansas, United States
Heartland Research Associates, LLC
🇺🇸Newton, Kansas, United States
Professional Research Network of Kansas, LLC
🇺🇸Wichita, Kansas, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Beacon Clinical Research, LLC
🇺🇸Brockton, Massachusetts, United States
Drug Trials America
🇺🇸Hartsdale, New York, United States
Premier Research - Austin
🇺🇸Austin, Texas, United States
Clinical Investigations of Texas, LLC
🇺🇸Plano, Texas, United States
Healthcare Research
🇺🇸Hazelwood, Missouri, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
Arroyo Medical Group, Inc
🇺🇸Pismo Beach, California, United States
Achieve Clinical Research, LLC
🇺🇸Birmingham, Alabama, United States
Medical Center
🇺🇸Carmichael, California, United States
Avail Clinical Research
🇺🇸DeLand, Florida, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Fleming Island Center for Clinical Research
🇺🇸Fleming Island, Florida, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
Peninsula Research, Inc
🇺🇸Ormond Beach, Florida, United States
St Johns Center for Clinical Research
🇺🇸Ponte Vedra, Florida, United States
Heartland Clinical Research, Inc
🇺🇸Omaha, Nebraska, United States
Troy Internal Medicine, PC / Research Department
🇺🇸Troy, Michigan, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Sundance Clinical Research, LLC
🇺🇸St Louis, Missouri, United States
Triad Clinical Research
🇺🇸Greensboro, North Carolina, United States
Palmetto Clinical Trial Services, LLC
🇺🇸Clinton, South Carolina, United States
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Charlottesville Medical Research Center, LLC
🇺🇸Charlottesville, Virginia, United States
Westside Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Medical Research Associates, Inc
🇺🇸Traverse City, Michigan, United States
Hypothetest, LLC
🇺🇸Roanoke, Virginia, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States