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Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT02405793
Recruitment Status : Withdrawn (Internal business decision not to move forward with study)
First Posted : April 1, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Meloxicam Test Capsules Drug: Meloxicam Tablets Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam low dose test capsule
Meloxicam SoluMatrix Capsules - low dose QD
Drug: Meloxicam Test Capsules
Experimental: Meloxicam high dose test capsule
Meloxicam SoluMatrix Capsules - high dose QD
Drug: Meloxicam Test Capsules
Active Comparator: Meloxicam tablets
Meloxicam Tablets QD
Drug: Meloxicam Tablets



Primary Outcome Measures :
  1. 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. [ Time Frame: Baseline to Week 6 ]

Secondary Outcome Measures :
  1. 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. [ Time Frame: Baseline to Week 6 ]
  2. 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. [ Time Frame: Baseline to Week 6 ]
  3. 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. [ Time Frame: Baseline to Week 6 ]
  4. Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3. [ Time Frame: 2 hours after dosing on Day 3 ]
  5. Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14. [ Time Frame: 2 hours after dosing on Day 14 ]
  6. Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 3. [ Time Frame: 2 hours after dosing on Day 3 ]
  7. Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale on Day 14. [ Time Frame: 2 hours after dosing on Day 14 ]
  8. Patient Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  9. Clinical Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  10. Amount of Rescue Medication Taken by Each Subject [ Time Frame: Baseline to Week 6/Early Termination ]
  11. Cumulative Discontinuations Due to Lack of Efficacy at Week 6 [ Time Frame: Baseline to Week 6 ]
  12. Responders with at Least a 10-mm Improvement in Mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score at Week 6. [ Time Frame: Baseline to Week 6 ]
  13. 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 [ Time Frame: Baseline to Week 6/Early Termination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT02405793     History of Changes
Other Study ID Numbers: MEL2-14-05
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: July 10, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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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