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



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:40 - Any
Updated:5/27/2013
Start Date:March 2013
End Date:July 2014
Contact:Alexis Gomez
Email:agomez@iroko.com
Phone:267-546-1426

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A Multicenter, Open-Label, Safety Study of Meloxicam SoluMatrix™ Capsules in Subjects With Osteoarthritis of the Knee or Hip


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


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 (ecept Meloxicam SoluMatrix Capsules), device,
or therapy within 30 days before Screening
We found this trial at
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