Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 5/27/2013 |
Start Date: | February 2013 |
End Date: | November 2013 |
Contact: | Alexis Gomez |
Email: | agomez@iroko.com |
Phone: | 267-546-1426 |
A Phase 3, Multicenter, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Fixed-Dose, Parallel-Group, Efficacy, and Safety Study of Meloxicam SoluMatrix™ Capsules in Patients With Pain Due to Osteoarthritis of the Knee or Hip
The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and
effective for the treatment of osteoarthritis pain of the knee or hip.
Inclusion Criteria:
- Primary diagnosis of Functional Class I-III OA of the hip or knee
- Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen
for OA pain
- Discontinued all analgesic therapy at Screening
- For women of child-bearing potential: a woman who is not pregnant and not nursing,
and who is practicing an acceptable method of birth control
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
- Previous participation in another clinical study of Meloxicam Capsules or received
any investigational drug or device or investigational therapy within 30 days before
Screening
We found this trial at
39
sites
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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611 NE Main Street
Simpsonville, South Carolina 29681
Simpsonville, South Carolina 29681
864-962-0431
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