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Study of Meloxicam Capsules to Treat Osteoarthritis Pain

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ClinicalTrials.gov Identifier: NCT01787188
Recruitment Status : Completed
First Posted : February 8, 2013
Results First Posted : March 11, 2015
Last Update Posted : March 11, 2015
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Tracking Information
First Submitted Date  ICMJE February 6, 2013
First Posted Date  ICMJE February 8, 2013
Results First Submitted Date  ICMJE February 6, 2015
Results First Posted Date  ICMJE March 11, 2015
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference is calculated as the WOMAC pain subscale score assessed at Week 12 minus the WOMAC pain subscale score assessed at baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2013)
The mean change from baseline in the WOMAC pain subscale score. [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT01787188 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2015)
  • Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. [ Time Frame: Baseline to Week 2 ]
    The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 2 minus the WOMAC pain subscale score assessed at baseline.
  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. [ Time Frame: Baseline to Week 6 ]
    The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Week 6 minus the WOMAC pain subscale score assessed at baseline.
  • Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    The pain in subjects with osteoarthritis was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score. The WOMAC pain subscale score is calculated as the average of the visual analogue scale (VAS) scores from 5 pain subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their pain level over the last 24 hours, with 0 mm representing "No Pain" and 100 mm representing "Extreme Pain". The WOMAC pain subscale score difference was calculated as the WOMAC pain subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC pain subscale score assessed at baseline.
  • Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: Baseline to Week 2 ]
    Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 2 minus the total WOMAC score assessed at baseline.
  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: Baseline to Week 6 ]
    Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 6 minus the total WOMAC score assessed at baseline.
  • Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Week 12/early termination minus the total WOMAC score assessed at baseline.
  • Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Pain, Stiffness, and Function Measured Using the Total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    Pain, stiffness, and function in subjects with osteoarthritis were measured using the Western Ontario and McMaster Universities (WOMAC) Index, which is a 24-item questionnaire. The total (composite) WOMAC score is calculated as the average of the mean visual analogue scale (VAS) scores from the questions in the pain, stiffness, and function subscales. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their response to each of the questions, with 0 mm representing "No Pain, Stiffness, or Difficulty" and 100 mm representing "Extreme Pain, Stiffness, and Difficulty". The total WOMAC score difference was calculated as the total WOMAC score assessed at Weeks 2, 6, and 12 minus the total WOMAC score assessed at baseline.
  • Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: Baseline to Week 2 ]
    The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 2 minus the WOMAC function subscale score assessed at baseline.
  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: Baseline to Week 6 ]
    The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 6 minus the WOMAC function subscale score assessed at baseline.
  • Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Week 12/early termination minus the WOMAC function subscale score assessed at baseline.
  • Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Function Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    The function in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function subscale score. The WOMAC function subscale score is calculated as the mean of the visual analogue scale scores from 17 function subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their functional limitation level over the last 24 hours, with 0 mm meaning "No Functional Limitation" and 100 mm meaning "Extreme Functional Limitation". The WOMAC function subscale score difference was calculated as the WOMAC function subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC function subscale score assessed at baseline.
  • Change From Baseline to Week 2 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: Baseline to Week 2 ]
    The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 2 minus the WOMAC stiffness subscale score assessed at baseline.
  • Change From Baseline to Week 6 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: Baseline to Week 6 ]
    The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 6 minus the WOMAC stiffness subscale score assessed at baseline.
  • Change From Baseline to Week 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Week 12/early termination minus the WOMAC stiffness subscale score assessed at baseline.
  • Change From Baseline to the Average of Weeks 2, 6, and 12 After Trial Entry in Osteoarthritis Stiffness Measured on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. [ Time Frame: Baseline to Week 12/Early Termination ]
    The stiffness in osteoarthritis subjects within the past 24 hours was measured at baseline using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) stiffness subscale score. The WOMAC stiffness subscale score is calculated as the mean of the visual analogue scale scores from 2 stiffness subscale questions. Subjects mark the VAS, which is a horizontal line 100 mm in length, with a single vertical line to indicate their stiffness level over the last 24 hours, with 0 mm meaning "No Stiffness" and 100 mm meaning "Extreme Stiffness". The WOMAC stiffness subscale score difference was calculated as the WOMAC stiffness subscale score assessed at Weeks 2, 6, and 12 minus the WOMAC stiffness subscale score assessed at baseline.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy, and Safety Study of Meloxicam SoluMatrix™ Capsules in Patients With Pain Due to Osteoarthritis of the Knee or Hip
Brief Summary The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Drug: Meloxicam Test Capsules
  • Drug: Placebo Capsules
Study Arms  ICMJE
  • Experimental: Meloxicam Test Capsules low dose QD
    Meloxicam Test Capsules low dose QD
    Intervention: Drug: Meloxicam Test Capsules
  • Experimental: Meloxicam Test Capsules high dose QD
    Meloxicam Test Capsules high dose QD
    Intervention: Drug: Meloxicam Test Capsules
  • Placebo Comparator: Placebo Capsule QD
    Placebo Capsule QD
    Intervention: Drug: Placebo Capsules
Publications * Altman R, Hochberg M, Gibofsky A, Jaros M, Young C. Efficacy and safety of low-dose SoluMatrix meloxicam in the treatment of osteoarthritis pain: a 12-week, phase 3 study. Curr Med Res Opin. 2015 Dec;31(12):2331-43. doi: 10.1185/03007995.2015.1112772.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2013)
403
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2013)
402
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Primary diagnosis of Functional Class I-III OA of the hip or knee
  • Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for OA pain
  • Discontinued all analgesic therapy at Screening
  • For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control

Exclusion Criteria:

  • History of allergic reaction or clinically significant intolerance to acetaminophen, aspirin, or any NSAIDs, including meloxicam
  • Requires continuous 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 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01787188
Other Study ID Numbers  ICMJE MEL3-12-02
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
Principal Investigator: Charles P Andrews, MD Diagnostics Research Group
Principal Investigator: Eddie Armas, MD Well Pharma Medical Research Corporation
Principal Investigator: Matthew Barton, MD Office of Matthew Barton, MD
Principal Investigator: David Bouda, MD Heartland Clinical Research, Inc
Principal Investigator: John Champlin, MD Medical Center
Principal Investigator: David Chen, MD Beacon Clinical Research, LLC
Principal Investigator: Melanie Christina, MD Clinical Investigations of Texas, LLC
Principal Investigator: James R Clark, MD Charlottesville Medical Research Center, LLC
Principal Investigator: Stephen Daniels, DO Premier Research Group - Austin
Principal Investigator: Richard R Eckert, MD Hypothetest, LLC
Principal Investigator: Brandon Essink, MD Meridian Clinical Research
Principal Investigator: John Flinchbaugh, DO Fleming Island Center for Clinical Research
Principal Investigator: Neil Fraser, MD Troy Internal Medicine, PC / Research Department
Principal Investigator: Richard M Glover, MD Heartland Research Associates, LLC
Principal Investigator: John M Hill, MD Avail Clinical Research
Principal Investigator: Curtis S Horn, MD Quality Research Inc
Principal Investigator: Jeffry Jacqmein, MD Jacksonville Center For Clinical Research
Principal Investigator: Richard Montgomery, MD Triad Clinical Research
Principal Investigator: Alan Kivitz, MD Altoona Center for Clinical Research
Principal Investigator: James Kopp, MD Radiant Research, Inc
Principal Investigator: Gregory F Lakin, DO Professional Research Network of Kansas, LLC
Principal Investigator: Sathish Modugu, MD Drug Trials America
Principal Investigator: Julie Mullen, DO Sterling Research Group, Ltd
Principal Investigator: Thomas Nussdorfer, MD Medical Research Associates, Inc
Principal Investigator: Naynesh Patel, MD Wells Institute for Health Awareness
Principal Investigator: Kashyap Patel, MD Peninsula Research, Inc
Principal Investigator: Stephen J Poland, MD Community Research
Principal Investigator: Larry D Reed, MD, PhD Healthcare Research
Principal Investigator: Erich Schramm, MD St. Johns Center for Clinical Research
Principal Investigator: Douglas R Schumacher, MD Radiant Research, Inc
Principal Investigator: Louis Stephens, MD Palmetto Clinical Trial Services, LLC
Principal Investigator: Mark Stich, DO Westside Center for Clinical Research
Principal Investigator: Haydn M Thomas, MD Clinical Trials Technology Inc
Principal Investigator: Susann Varano, MD Clinical Research Consulting
Principal Investigator: Larkin T Wadsworth, MD Sundance Clinical Research, LLC
Principal Investigator: Robert J Wagner, MD Community Research
Principal Investigator: Matthew A Wenker, MD Sterling Research Group, Ltd
Principal Investigator: Hayes T Williams, MD, PhD Achieve Clinical Research, LLC
Principal Investigator: James Maynard, MD Community Research
Principal Investigator: Roger Guthrie, MD Arroyo Medical Group, Inc
PRS Account Iroko Pharmaceuticals, LLC
Verification Date March 2015

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