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Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Internal business decision not to move forward with study)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

Tracking Information
First Submitted Date  ICMJE March 27, 2015
First Posted Date  ICMJE April 1, 2015
Last Update Posted Date July 10, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02405793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Patient Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  • Clinical Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  • Amount of Rescue Medication Taken by Each Subject [ Time Frame: Baseline to Week 6/Early Termination ]
  • Cumulative Discontinuations Due to Lack of Efficacy at Week 6 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: Baseline to Week 6/Early Termination ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Patient Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  • Clinical Global Impression of Change [ Time Frame: Baseline to Week 6/Early Termination ]
  • Amount of Rescue Medication Taken by Each Subject [ Time Frame: Baseline to Week 6/Early Termination ]
  • Cumulative Discontinuations Due to Lack of Efficacy at Week 6 [ Time Frame: 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. [ Time Frame: Baseline to Week 6 ]
  • Safety of Meloxicam SoluMatrix Capsules 5 mg, Meloxicam SoluMatrix Capsules 10 mg, and Meloxicam 15 mg 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Meloxicam Test Capsules
  • Drug: Meloxicam Tablets
Study Arms  ICMJE
  • Experimental: Meloxicam low dose test capsule
    Meloxicam SoluMatrix Capsules - low dose QD
    Intervention: Drug: Meloxicam Test Capsules
  • Experimental: Meloxicam high dose test capsule
    Meloxicam SoluMatrix Capsules - high dose QD
    Intervention: Drug: Meloxicam Test Capsules
  • Active Comparator: Meloxicam tablets
    Meloxicam Tablets QD
    Intervention: Drug: Meloxicam Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: July 8, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2015)
75
Estimated Study Completion Date  ICMJE July 2015
Estimated Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT02405793
Other Study ID Numbers  ICMJE MEL2-14-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Iroko Pharmaceuticals, LLC
Study Sponsor  ICMJE Iroko Pharmaceuticals, LLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Iroko Pharmaceuticals, LLC
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP