Clinical trial NCT02405793: Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain
Official title: A Phase 2b, Multicenter, Randomized, Single Blind, Fixed Dose, Parallel Group Study to Evaluate the Efficacy and Safety of Meloxicam SoluMatrix® [Test] Capsules and Meloxicam Tablets in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteoarthritis
Lead sponsor: Iroko Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2015-04-01
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Baseline to Week 6
Secondary outcomes:
measure: 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.
timeFrame: Baseline to Week 6
measure: 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.
timeFrame: Baseline to Week 6
measure: 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.
timeFrame: Baseline to Week 6
measure: Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3.
timeFrame: 2 hours after dosing on Day 3
measure: Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14.
timeFrame: 2 hours after dosing on Day 14
measure: Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3.
timeFrame: 2 hours after dosing on Day 3
measure: Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14.
timeFrame: 2 hours after dosing on Day 14
measure: Patient Global Impression of Change
timeFrame: Baseline to Week 6/Early Termination
measure: Clinical Global Impression of Change
timeFrame: Baseline to Week 6/Early Termination
measure: Amount of Rescue Medication Taken by Each Subject
timeFrame: Baseline to Week 6/Early Termination
measure: Cumulative Discontinuations Due to Lack of Efficacy at Week 6
timeFrame: Baseline to Week 6
measure: Responders with at Least a 10-mm Improvement in Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 6.
timeFrame: Baseline to Week 6
measure: 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
timeFrame: Baseline to Week 6/Early Termination
Other outcomes:
Locations:
Study officials:
References: