- Subject has been taking an NSAID at least 15 of the past 30 days for index knee pain
- Grades 2 or 3 OA as defined by the Kellgren and Lawrence Grading System of the medial
tibiofemoral joint (joint space narrowing in the medial compartment > lateral
compartment as assessed by x-ray) using the Altman Atlas of OA7. This must be
documented with a report from an x-ray of the study joint taken either at screening or
within 1 year prior to screening
- Subject meets American College of Rheumatology (ACR) clinical classification criteria
for osteoarthritis of the knee, defined by the following: Knee pain and at least 3 of
the following: oAge >50 oMorning stiffness oBony tenderness oBony enlargement oNo palpable warmth of synovium.
- Subject has a documented history of an allergic reaction (hives, rash, etc.) or a
clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids
- Significant pain outside the index knee, including significant hip or back pain that
can not be distinguished from OA pain or that interferes with ability to walk.
(Patients with bilateral knee OA will be allowed into the study. The index knee should
be defined as the more painful knee
- Predominantly patellofemoral knee osteoarthritis in the index knee as assessed by
- Subject who are unable to discontinue all formulations of prior analgesics other than
acetaminophen during the Washout Period of the study, or who are anticipated to be
unable to discontinue rescue medication for 24 hours prior to the respective visits.
(Low dose aspirin may be taken for cardiac prophylaxis
- Excessive signal knee joint laxity indicative of functional ligamentous deficiency