Study of Meloxicam Capsules to Treat Osteoarthritis Pain

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Drug: Meloxicam Test Capsules; Drug: Placebo Capsules

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35216
      • Achieve Clinical Research, LLC
  • California
    • Carmichael, California, United States, 95608
      • Medical Center
    • Pismo Beach, California, United States, 93449
      • Arroyo Medical Group, Inc
  • Connecticut
    • Milford, Connecticut, United States, 06460
      • Clinical Research Consulting
  • Florida
    • DeLand, Florida, United States, 32720
      • Avail Clinical Research
    • Fleming Island, Florida, United States, 32003
      • Fleming Island Center for Clinical Research
    • Jacksonville, Florida, United States, 32205
      • Westside Center for Clinical Research
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research Corporation
    • Ormond Beach, Florida, United States, 32174
      • Peninsula Research, Inc
    • Ponte Vedra, Florida, United States, 32081
      • St Johns Center For Clinical Research
  • Kansas
    • Newton, Kansas, United States, 67114
      • Heartland Research Associates, LLC
    • Prairie Village, Kansas, United States, 66206
      • Clinical Trials Technology Inc
    • Wichita, Kansas, United States, 67203
      • Professional Research Network of Kansas, LLC
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Community Research
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
      • Beacon Clinical Research, LLC
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Medical Research Associates, Inc
    • Troy, Michigan, United States, 48098
      • Troy Internal Medicine, PC / Research Department
  • Missouri
    • Hazelwood, Missouri, United States, 63042
      • HealthCare Research
    • St Louis, Missouri, United States, 63141
      • Sundance Clinical Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
    • Omaha, Nebraska, United States, 68134
      • Heartland Clinical Research, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89144
      • Office of Matthew Barton, MD
  • New York
    • Hartsdale, New York, United States, 10530
      • Drug Trials America
  • North Carolina
    • Greensboro, North Carolina, United States, 27408
      • Triad Clinical Research
  • Ohio
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group, Ltd
    • Cincinnati, Ohio, United States, 45227
      • Community Research
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Group, Ltd
    • Cincinnati, Ohio, United States, 45255
      • Community Research - Anderson
    • Columbus, Ohio, United States, 43212
      • Radiant Research, Inc
    • Kettering, Ohio, United States, 45429
      • Wells Institute for Health Awareness
  • Pennsylvania
    • Duncansville, Pennsylvania, United States, 16635
      • Altoona Center For Clinical Research
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Radiant Research, Inc
    • Clinton, South Carolina, United States, 29325
      • Palmetto Clinical Trial Services, LLC
  • Texas
    • Austin, Texas, United States, 78705
      • Premier Research - Austin
    • Plano, Texas, United States, 75075
      • Clinical Investigations of Texas, LLC
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc
  • Virginia
    • Charlottesville, Virginia, United States, 22911
      • Charlottesville Medical Research Center, LLC
    • Roanoke, Virginia, United States, 24018
      • HypotheTest, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meloxicam Test Capsules low dose QD	Drug: Meloxicam Test Capsules
Experimental: Meloxicam Test Capsules high dose QD	Drug: Meloxicam Test Capsules
Placebo Comparator: Placebo Capsule QD	Drug: Placebo Capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to Week 12/Early Termination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline to Week 2
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.	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.	Baseline to Week 6
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 2
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.	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.	Baseline to Week 6
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 2
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.	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.	Baseline to Week 6
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 2
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.	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.	Baseline to Week 6
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.	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.	Baseline to Week 12/Early Termination
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.	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.	Baseline to Week 12/Early Termination

Collaborators and Investigators

• Sponsor: Iroko Pharmaceuticals, LLC
• Investigators: Principal Investigator: Alan Kivitz, MD, Altoona Center For Clinical Research; Principal Investigator: Jeffry Jacqmein, MD, Jacksonville Center for Clinical Research; Principal Investigator: John Champlin, MD, Medical Center; Principal Investigator: Larkin T Wadsworth, MD, Sundance Clinical Research, LLC; 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: 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: Richard Montgomery, MD, Triad 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: 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 6, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 8, 2013

Study Record Updates

• Last Update Posted (Estimate): March 11, 2015
• Last Update Submitted That Met QC Criteria: March 9, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Meloxicam
• Other Study ID Numbers: MEL3-12-02