Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip
1 other identifier
interventional
600
1 country
40
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2013
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2013
CompletedFirst Posted
Study publicly available on registry
March 1, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
May 12, 2015
CompletedMay 12, 2015
April 1, 2015
1.3 years
February 21, 2013
April 24, 2015
April 24, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Safety of Meloxicam 10 mg as Assessed by the Incidence of Adverse Events From Baseline to Week 52 or 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.
Baseline to Week 52/Early Termination
Study Arms (1)
Meloxicam Test Capsules
EXPERIMENTALOne Capsule QD
Interventions
Eligibility Criteria
You may qualify if:
- 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
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
- Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Birmingham, Alabama, 35216, United States
Unknown Facility
Phoenix, Arizona, 85053, United States
Unknown Facility
Carmichael, California, 95608, United States
Unknown Facility
Pismo Beach, California, 93449, United States
Unknown Facility
Milford, Connecticut, 06460, United States
Unknown Facility
DeLand, Florida, 32720, United States
Unknown Facility
Fleming Island, Florida, 32003, United States
Unknown Facility
Jacksonville, Florida, 32205, United States
Unknown Facility
Jacksonville, Florida, 32216, United States
Unknown Facility
Miami, Florida, 33143, United States
Unknown Facility
Ormond Beach, Florida, 32174, United States
Unknown Facility
Ponte Vedra, Florida, 32081, United States
Unknown Facility
Newton, Kansas, 67114, United States
Unknown Facility
Prairie Village, Kansas, 66206, United States
Unknown Facility
Wichita, Kansas, 67203, United States
Unknown Facility
Crestview Hills, Kentucky, 41017, United States
Unknown Facility
Brockton, Massachusetts, 02301, United States
Unknown Facility
Traverse City, Michigan, 49684, United States
Unknown Facility
Troy, Michigan, 48098, United States
Unknown Facility
Hazelwood, Missouri, 63042, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Omaha, Nebraska, 68134, United States
Unknown Facility
Las Vegas, Nevada, 89144, United States
Unknown Facility
Hartsdale, New York, 10530, United States
Unknown Facility
Greensboro, North Carolina, 27408, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cincinnati, Ohio, 45255, United States
Unknown Facility
Cincinnati, Ohio, 45256, United States
Unknown Facility
Columbus, Ohio, 43212, United States
Unknown Facility
Kettering, Ohio, 45429, United States
Unknown Facility
Duncansville, Pennsylvania, 16635, United States
Unknown Facility
Anderson, South Carolina, 29621, United States
Unknown Facility
Clinton, South Carolina, 29325, United States
Unknown Facility
Austin, Texas, 78705, United States
Unknown Facility
Plano, Texas, 75075, United States
Unknown Facility
San Antonio, Texas, 78209, United States
Unknown Facility
San Antonio, Texas, 78229, United States
Unknown Facility
Charlottesville, Virginia, 22911, United States
Unknown Facility
Roanoke, Virginia, 24018, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alexis Gomez, Director of Clinical Operations
- Organization
- Iroko Pharmaceuticals, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2013
First Posted
March 1, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
May 12, 2015
Results First Posted
May 12, 2015
Record last verified: 2015-04