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Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

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: NCT01801735
Recruitment Status : Completed
First Posted : March 1, 2013
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Brief Summary:
The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Meloxicam Test Capsules Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 600 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
Study Start Date : March 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Meloxicam

Arm Intervention/treatment
Experimental: Meloxicam Test Capsules
One Capsule QD
Drug: Meloxicam Test Capsules



Primary Outcome Measures :
  1. Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or Early Termination [ Time Frame: Baseline to Week 52/Early Termination ]
    The safety of Meloxicam 10 mg was assessed by the number of subjects with treatment-emergent adverse events (TEAEs), severe TEAEs, serious adverse events, treatment-related TEAEs, and adverse events (AEs) leading to discontinuation and subjects who died.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is male or female ≥ 40 years of age
  • If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
  • Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
  • Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
  • If female and of childbearing potential, is nonlactating and nonpregnant

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
  • Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801735


Locations
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United States, Alabama
Birmingham, Alabama, United States, 35216
United States, Arizona
Phoenix, Arizona, United States, 85053
United States, California
Carmichael, California, United States, 95608
Pismo Beach, California, United States, 93449
United States, Connecticut
Milford, Connecticut, United States, 06460
United States, Florida
DeLand, Florida, United States, 32720
Fleming Island, Florida, United States, 32003
Jacksonville, Florida, United States, 32205
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33143
Ormond Beach, Florida, United States, 32174
Ponte Vedra, Florida, United States, 32081
United States, Kansas
Newton, Kansas, United States, 67114
Prairie Village, Kansas, United States, 66206
Wichita, Kansas, United States, 67203
United States, Kentucky
Crestview Hills, Kentucky, United States, 41017
United States, Massachusetts
Brockton, Massachusetts, United States, 02301
United States, Michigan
Traverse City, Michigan, United States, 49684
Troy, Michigan, United States, 48098
United States, Missouri
Hazelwood, Missouri, United States, 63042
St Louis, Missouri, United States, 63141
United States, Nebraska
Omaha, Nebraska, United States, 68134
United States, Nevada
Las Vegas, Nevada, United States, 89144
United States, New York
Hartsdale, New York, United States, 10530
United States, North Carolina
Greensboro, North Carolina, United States, 27408
United States, Ohio
Cincinnati, Ohio, United States, 45219
Cincinnati, Ohio, United States, 45227
Cincinnati, Ohio, United States, 45255
Cincinnati, Ohio, United States, 45256
Columbus, Ohio, United States, 43212
Kettering, Ohio, United States, 45429
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
United States, South Carolina
Anderson, South Carolina, United States, 29621
Clinton, South Carolina, United States, 29325
United States, Texas
Austin, Texas, United States, 78705
Plano, Texas, United States, 75075
San Antonio, Texas, United States, 78209
San Antonio, Texas, United States, 78229
United States, Virginia
Charlottesville, Virginia, United States, 22911
Roanoke, Virginia, United States, 24018
Sponsors and Collaborators
Iroko Pharmaceuticals, LLC
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Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01801735    
Other Study ID Numbers: MEL3-12-03
First Posted: March 1, 2013    Key Record Dates
Results First Posted: May 12, 2015
Last Update Posted: May 12, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Meloxicam
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action