Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
NCT ID: NCT01801735
Last Updated: 2015-05-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
600 participants
INTERVENTIONAL
2013-03-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Meloxicam Test Capsules
One Capsule QD
Meloxicam Test Capsules
Interventions
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Meloxicam Test Capsules
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Iroko Pharmaceuticals, LLC
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Phoenix, Arizona, United States
Carmichael, California, United States
Pismo Beach, California, United States
Milford, Connecticut, United States
DeLand, Florida, United States
Fleming Island, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Ponte Vedra, Florida, United States
Newton, Kansas, United States
Prairie Village, Kansas, United States
Wichita, Kansas, United States
Crestview Hills, Kentucky, United States
Brockton, Massachusetts, United States
Traverse City, Michigan, United States
Troy, Michigan, United States
Hazelwood, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Hartsdale, New York, United States
Greensboro, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Kettering, Ohio, United States
Duncansville, Pennsylvania, United States
Anderson, South Carolina, United States
Clinton, South Carolina, United States
Austin, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Charlottesville, Virginia, United States
Roanoke, Virginia, United States
Countries
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Other Identifiers
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MEL3-12-03
Identifier Type: -
Identifier Source: org_study_id
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