Meloxicam SoluMatrix® Capsules vs Meloxicam Tablets to Treat Osteoarthritis Pain

• Status: Withdrawn
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iroko Pharmaceuticals, LLC
• Treatments: Meloxicam

Criteria

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