Study of Meloxicam Capsules to Treat Osteoarthritis Pain

NCT01787188 | Completed Phase 3 Results

• 1 other identifier: MEL3-12-02
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 40

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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.

  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.

  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.

  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.

  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.

  Baseline to Week 6

Study Arms (3)

Meloxicam Test Capsules low dose QD

EXPERIMENTAL

Meloxicam Test Capsules low dose QD

Drug: Meloxicam Test Capsules

Meloxicam Test Capsules high dose QD

EXPERIMENTAL

Meloxicam Test Capsules high dose QD

Drug: Meloxicam Test Capsules

Placebo Capsule QD

PLACEBO COMPARATOR

Placebo Capsule QD

Drug: Placebo Capsules

Interventions

Meloxicam Test Capsules DRUG

Meloxicam Test Capsules low dose QD

Placebo Capsules DRUG

Placebo Capsule QD

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC: lead

Study Sites (40)

Achieve Clinical Research, LLC

Birmingham, Alabama, 35216, United States

Location

Medical Center

Carmichael, California, 95608, United States

Location

Arroyo Medical Group, Inc

Pismo Beach, California, 93449, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Avail Clinical Research

DeLand, Florida, 32720, United States

Location

Fleming Island Center for Clinical Research

Fleming Island, Florida, 32003, United States

Location

Westside Center for Clinical Research

Jacksonville, Florida, 32205, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33143, United States

Location

Peninsula Research, Inc

Ormond Beach, Florida, 32174, United States

Location

St Johns Center for Clinical Research

Ponte Vedra, Florida, 32081, United States

Location

Heartland Research Associates, LLC

Newton, Kansas, 67114, United States

Location

Clinical Trials Technology Inc

Prairie Village, Kansas, 66206, United States

Location

Professional Research Network of Kansas, LLC

Wichita, Kansas, 67203, United States

Location

Community Research

Crestview Hills, Kentucky, 41017, United States

Location

Beacon Clinical Research, LLC

Brockton, Massachusetts, 02301, United States

Location

Medical Research Associates, Inc

Traverse City, Michigan, 49684, United States

Location

Troy Internal Medicine, PC / Research Department

Troy, Michigan, 48098, United States

Location

Healthcare Research

Hazelwood, Missouri, 63042, United States

Location

Sundance Clinical Research, LLC

St Louis, Missouri, 63141, United States

Location

Heartland Clinical Research, Inc

Omaha, Nebraska, 68134, United States

Location

Meridian Clinical Research

Omaha, Nebraska, 68134, United States

Location

Office of Matthew Barton, MD

Las Vegas, Nevada, 89144, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Triad Clinical Research

Greensboro, North Carolina, 27408, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, 45219, United States

Location

Community Research

Cincinnati, Ohio, 45227, United States

Location

Sterling Research Group, Ltd

Cincinnati, Ohio, 45246, United States

Location

Community Research - Anderson

Cincinnati, Ohio, 45255, United States

Location

Radiant Research, Inc

Columbus, Ohio, 43212, United States

Location

Wells Institute for Health Awareness

Kettering, Ohio, 45429, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Radiant Research, Inc

Anderson, South Carolina, 29621, United States

Location

Palmetto Clinical Trial Services, LLC

Clinton, South Carolina, 29325, United States

Location

Premier Research - Austin

Austin, Texas, 78705, United States

Location

Clinical Investigations of Texas, LLC

Plano, Texas, 75075, United States

Location

Quality Research Inc

San Antonio, Texas, 78209, United States

Location

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research Center, LLC

Charlottesville, Virginia, 22911, United States

Location

Hypothetest, LLC

Roanoke, Virginia, 24018, United States

Location

Related Publications (1)

• 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.

  PMID: 26503347 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Daniel Solorio, Executive Director of Clinical Operations
• Organization: Iroko Pharmaceuticals, LLC

dsolorio@iroko.com

267-546-3150

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: February 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: March 11, 2015
• Results First Posted: March 11, 2015

Record last verified: 2015-03

Locations

US (40)