Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
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| ClinicalTrials.gov Identifier: NCT01801735 |
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Recruitment Status :
Completed
First Posted : March 1, 2013
Results First Posted : May 12, 2015
Last Update Posted : May 12, 2015
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Sponsor:
Iroko Pharmaceuticals, LLC
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
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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 |
| 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 Genetics related topics:
Osteoarthritis
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Meloxicam
| Arm | Intervention/treatment |
|---|---|
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Experimental: Meloxicam Test Capsules
One Capsule QD
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Drug: Meloxicam Test Capsules |
Primary Outcome Measures :
- 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.
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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
| 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
| 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 |