Status:
COMPLETED
Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip
Lead Sponsor:
Iroko Pharmaceuticals, LLC
Conditions:
Osteoarthritis
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT01801735
Start Date
March 1 2013
End Date
August 1 2014
Last Update
May 12 2015
Active Locations (40)
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1
Birmingham, Alabama, United States, 35216
2
Phoenix, Arizona, United States, 85053
3
Carmichael, California, United States, 95608
4
Pismo Beach, California, United States, 93449