Study of Meloxicam Capsules in Subjects With Osteoarthritis of the Knee or Hip

Completed · Phase 3

Conditions studied: Osteoarthritis

In brief

The purpose of this study is to evaluate the safety of Meloxicam SoluMatrix Capsules for up to 52 weeks in subjects with pain due to osteoarthritis (OA) of the knee or hip

Key facts

Study ID

NCT01801735

Run by

Iroko Pharmaceuticals, LLC

People needed

600

Starts

2013-03-01

Expected to finish

2014-08-01

Last updated by the study team

2015-05-12

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is male or female ≥ 40 years of age
• If a participant in the previous MEL3-12-02 study, completed the study and did not discontinue for lack of efficacy or safety
• Has a diagnosis of OA of the hip or knee with ongoing knee and/or articular hip pain
• Chronic user of nonsteroidal anti-inflammatory drugs (NSAIDs) and/or acetaminophen for OA pain
• If female and of childbearing potential, is nonlactating and nonpregnant

You may not qualify if…

• 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
• Has received any investigational drug (except Meloxicam SoluMatrix Capsules), device, or therapy within 30 days before Screening

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Phoenix, Arizona, United States
• Study site — Carmichael, California, United States
• Study site — Pismo Beach, California, United States
• Study site — Milford, Connecticut, United States
• Study site — DeLand, Florida, United States
• Study site — Fleming Island, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Ormond Beach, Florida, United States
• Study site — Ponte Vedra, Florida, United States
• Study site — Newton, Kansas, United States
• Study site — Prairie Village, Kansas, United States
• Study site — Wichita, Kansas, United States
• Study site — Crestview Hills, Kentucky, United States
• Study site — Brockton, Massachusetts, United States
• Study site — Traverse City, Michigan, United States
• Study site — Troy, Michigan, United States
• Study site — Hazelwood, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Omaha, Nebraska, United States
• Study site — Las Vegas, Nevada, United States
• Study site — Hartsdale, New York, United States
• Study site — Greensboro, North Carolina, United States

Full record on ClinicalTrials.gov

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