Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain
Status: | Completed |
---|---|
Conditions: | Arthritis, Osteoarthritis (OA) |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 7/11/2015 |
Start Date: | May 2015 |
End Date: | July 2015 |
Contact: | Claire Sheridan, PhD |
Email: | csheridan@iroko.com |
Phone: | 267-546-3061 |
A Phase 2b, Multicenter, Randomized, Single Blind, Fixed Dose, Parallel Group Study to Evaluate the Efficacy and Safety of Meloxicam SoluMatrix® [Test] Capsules and Meloxicam Tablets in Patients With Pain Due to Osteoarthritis of the Knee or Hip
The purpose of this study is to evaluate the safety and efficacy of a low dose and a high
dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain
due to osteoarthritis of the knee or hip.
dose of Meloxicam SoluMatrix® Capsules versus Meloxicam Tablets for the treatment of pain
due to osteoarthritis of the knee or hip.
Inclusion Criteria:
- Primary diagnosis of Functional Class I-III osteoarthritis (OA) of the hip or knee
- Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen
for OA pain
- Discontinued all analgesic therapy at Screening
- For women of childbearing potential: a woman who is not pregnant and not nursing,
and who is practicing an acceptable method of birth control
- Ability to ambulate
Exclusion Criteria:
- History of allergic reaction or clinically significant intolerance to acetaminophen,
aspirin, or any NSAIDs, including meloxicam
- Requires regular (more than 2 doses per week) 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/tablets 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
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