Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

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