Phase 3
Completed N=403
Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Source: ClinicalTrials.gov NCT01787188 ↗Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: 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. — -36.52; -34.41; -25.68 mm — p=0.0005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
-36.52; -34.41; -25.68 | 0.0005 sig |
| SECONDARY 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. |
-26.12; -20.42; -16.51 | 0.0003 sig |
| SECONDARY 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. |
-31.31; -30.82; -20.98 | 0.0004 sig |
| SECONDARY 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. |
-30.51; -27.89; -20.07 | <0.0001 sig |
| SECONDARY 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. |
-21.62; -15.67; -11.28 | <0.0001 sig |
| SECONDARY 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. |
-25.86; -25.45; -16.03 | 0.0008 sig |
| SECONDARY 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. |
-29.85; -29.71; -19.72 | 0.0014 sig |
| SECONDARY 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. |
-25.15; -22.83; -14.67 | <0.0001 sig |
| SECONDARY 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. |
-20.45; -14.41; -10.00 | 0.0001 sig |
| SECONDARY 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. |
-24.41; -24.38; -14.73 | 0.0012 sig |
| SECONDARY 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. |
-28.21; -28.40; -17.95 | 0.0014 sig |
| SECONDARY 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. |
-23.78; -21.70; -13.26 | <0.0001 sig |
| SECONDARY 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. |
-19.84; -14.88; -8.86 | 0.0001 sig |
| SECONDARY 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. |
-26.52; -23.39; -14.30 | 0.0001 sig |
| SECONDARY 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. |
-29.68; -28.10; -18.74 | 0.0012 sig |
| SECONDARY 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. |
-24.76; -21.33; -13.09 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01787188). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.