Study of Meloxicam Capsules to Treat Osteoarthritis Pain
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01787188 |
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Recruitment Status :
Completed
First Posted : February 8, 2013
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Osteoarthritis | Drug: Meloxicam Test Capsules Drug: Placebo Capsules | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 403 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | February 2013 |
| Actual Primary Completion Date : | October 2013 |
| Actual Study Completion Date : | October 2013 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Meloxicam Test Capsules low dose QD
Meloxicam Test Capsules low dose QD
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Drug: Meloxicam Test Capsules |
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Experimental: Meloxicam Test Capsules high dose QD
Meloxicam Test Capsules high dose QD
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Drug: Meloxicam Test Capsules |
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Placebo Comparator: Placebo Capsule QD
Placebo Capsule QD
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Drug: Placebo Capsules |
- 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. [ Time Frame: 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.
- 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. [ Time Frame: 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 Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. [ Time Frame: 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. [ Time Frame: 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 Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: 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 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: 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. [ Time Frame: 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 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. [ Time Frame: 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 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: 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. [ Time Frame: 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 Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: 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.
- 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. [ Time Frame: 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 Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: 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 Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: 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 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: 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. [ Time Frame: 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01787188
Show 40 study locations
| Principal Investigator: | Charles P Andrews, MD | Diagnostics Research Group | |
| Principal Investigator: | Eddie Armas, MD | Well Pharma Medical Research Corporation | |
| Principal Investigator: | Matthew Barton, MD | Office of Matthew Barton, MD | |
| Principal Investigator: | David Bouda, MD | Heartland Clinical Research, Inc | |
| Principal Investigator: | John Champlin, MD | Medical Center | |
| Principal Investigator: | David Chen, MD | Beacon Clinical Research, LLC | |
| Principal Investigator: | Melanie Christina, MD | Clinical Investigations of Texas, LLC | |
| Principal Investigator: | James R Clark, MD | Charlottesville Medical Research Center, LLC | |
| Principal Investigator: | Stephen Daniels, DO | Premier Research Group - Austin | |
| Principal Investigator: | Richard R Eckert, MD | Hypothetest, LLC | |
| Principal Investigator: | Brandon Essink, MD | Meridian Clinical Research | |
| Principal Investigator: | John Flinchbaugh, DO | Fleming Island Center for Clinical Research | |
| Principal Investigator: | Neil Fraser, MD | Troy Internal Medicine, PC / Research Department | |
| Principal Investigator: | Richard M Glover, MD | Heartland Research Associates, LLC | |
| Principal Investigator: | John M Hill, MD | Avail Clinical Research | |
| Principal Investigator: | Curtis S Horn, MD | Quality Research Inc | |
| Principal Investigator: | Jeffry Jacqmein, MD | Jacksonville Center For Clinical Research | |
| Principal Investigator: | Richard Montgomery, MD | Triad Clinical Research | |
| Principal Investigator: | Alan Kivitz, MD | Altoona Center for Clinical Research | |
| Principal Investigator: | James Kopp, MD | Radiant Research, Inc | |
| Principal Investigator: | Gregory F Lakin, DO | Professional Research Network of Kansas, LLC | |
| Principal Investigator: | Sathish Modugu, MD | Drug Trials America | |
| Principal Investigator: | Julie Mullen, DO | Sterling Research Group, Ltd | |
| Principal Investigator: | Thomas Nussdorfer, MD | Medical Research Associates, Inc | |
| Principal Investigator: | Naynesh Patel, MD | Wells Institute for Health Awareness | |
| Principal Investigator: | Kashyap Patel, MD | Peninsula Research, Inc | |
| Principal Investigator: | Stephen J Poland, MD | Community Research | |
| Principal Investigator: | Larry D Reed, MD, PhD | Healthcare Research | |
| Principal Investigator: | Erich Schramm, MD | St. Johns Center for Clinical Research | |
| Principal Investigator: | Douglas R Schumacher, MD | Radiant Research, Inc | |
| Principal Investigator: | Louis Stephens, MD | Palmetto Clinical Trial Services, LLC | |
| Principal Investigator: | Mark Stich, DO | Westside Center for Clinical Research | |
| Principal Investigator: | Haydn M Thomas, MD | Clinical Trials Technology Inc | |
| Principal Investigator: | Susann Varano, MD | Clinical Research Consulting | |
| Principal Investigator: | Larkin T Wadsworth, MD | Sundance Clinical Research, LLC | |
| Principal Investigator: | Robert J Wagner, MD | Community Research | |
| Principal Investigator: | Matthew A Wenker, MD | Sterling Research Group, Ltd | |
| Principal Investigator: | Hayes T Williams, MD, PhD | Achieve Clinical Research, LLC | |
| Principal Investigator: | James Maynard, MD | Community Research | |
| Principal Investigator: | Roger Guthrie, MD | Arroyo Medical Group, Inc |
| Responsible Party: | Iroko Pharmaceuticals, LLC |
| ClinicalTrials.gov Identifier: | NCT01787188 |
| Other Study ID Numbers: |
MEL3-12-02 |
| First Posted: | February 8, 2013 Key Record Dates |
| Results First Posted: | March 11, 2015 |
| Last Update Posted: | March 11, 2015 |
| Last Verified: | March 2015 |
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Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Meloxicam Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |