Measuring Gait And Self-Reported Pain In Patients With Osteoarthritis Of The Knee Using Placebo/Oxycodone/Celecoxib.
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: celecoxib; Oxycodone; placebo
Intervention description: oral, 100 mg bid; oral, 20 mg bid; oral bid
Intervention MeSH terms: Celecoxib; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 6.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The Purpose of this trial is to evaluate the use of a cross-over trial design in an
      osteoarthritis population. We will determine the inter- and intra-subject variability in
      osteoarthritis (OA) endpoints and evaluate if efficacy can be detected by measuring OA
      endpoints following treatment with 2 different types of analgesics in a crossover study of
      this design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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 <30 minutes oCrepitus on active motion
             oBony tenderness oBony enlargement oNo palpable warmth of synovium.

        Exclusion Criteria:

          -  Subject has a documented history of an allergic reaction (hives, rash, etc.) or a
             clinically significant intolerance to celecoxib, sulfonamides, aspirin, or opioids
             including oxycodone

          -  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
             clinical examination

          -  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