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

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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.


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
We found this trial at
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Duncansville, Pennsylvania 16635
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Crestview Hills, Kentucky 41017
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Greensboro, North Carolina 27401
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