Osteoarthritis
Conditions
Brief summary
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.
Interventions
DRUGMeloxicam Tablets
Sponsors
Iroko Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 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 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 |
| 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 |
| 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 |
| Patient Global Impression of Change | Baseline to Week 6/Early Termination |
Outcome results
None listed