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Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

Primary Purpose

Osteoarthritis

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Meloxicam Test Capsules
Meloxicam Test Capsules
Meloxicam Tablets
Sponsored by
Iroko Pharmaceuticals, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Meloxicam low dose test capsule

    Meloxicam high dose test capsule

    Meloxicam tablets

    Arm Description

    Meloxicam SoluMatrix Capsules - low dose QD

    Meloxicam SoluMatrix Capsules - high dose QD

    Meloxicam Tablets QD

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 3.
    Change From Pre-dose to 2 Hours Post-dose in Pain Intensity as Measured by the Numerical Pain Rating Scale on Day 14.
    Change From Pre-dose to 2 Hours Post-dose in Morning Stiffness Severity as Measured by the Numerical Rating Scale 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.
    Patient Global Impression of Change
    Clinical Global Impression of Change
    Amount of Rescue Medication Taken by Each Subject
    Cumulative Discontinuations Due to Lack of Efficacy at 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.
    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

    Full Information

    First Posted
    March 27, 2015
    Last Updated
    July 8, 2015
    Sponsor
    Iroko Pharmaceuticals, LLC
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02405793
    Brief Title
    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

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Internal business decision not to move forward with study
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    July 2015 (Anticipated)
    Study Completion Date
    July 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Iroko Pharmaceuticals, LLC

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Osteoarthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Meloxicam low dose test capsule
    Arm Type
    Experimental
    Arm Description
    Meloxicam SoluMatrix Capsules - low dose QD
    Arm Title
    Meloxicam high dose test capsule
    Arm Type
    Experimental
    Arm Description
    Meloxicam SoluMatrix Capsules - high dose QD
    Arm Title
    Meloxicam tablets
    Arm Type
    Active Comparator
    Arm Description
    Meloxicam Tablets QD
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam Test Capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam Test Capsules
    Intervention Type
    Drug
    Intervention Name(s)
    Meloxicam Tablets
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    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
    Title
    Patient Global Impression of Change
    Time Frame
    Baseline to Week 6/Early Termination
    Title
    Clinical Global Impression of Change
    Time Frame
    Baseline to Week 6/Early Termination
    Title
    Amount of Rescue Medication Taken by Each Subject
    Time Frame
    Baseline to Week 6/Early Termination
    Title
    Cumulative Discontinuations Due to Lack of Efficacy at Week 6
    Time Frame
    Baseline to Week 6
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

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