Please select the eligibility criteria that correspond to the clinical trial below.
Title: MEASURES OF GAIT AND SELF-REPORTED PAIN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE: A RANDOMIZED, SINGLE-BLIND WASHOUT, DOUBLE-BLIND TREATMENT, DOUBLE DUMMY CROSS-OVER PILOT TRIAL USING PLACEBO, OXYCODONE AND CELECOXIB (A9011030)
Brief 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.


Options:
A: 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
B: Inclusion Criteria:

* A clinical diagnosis of osteoarthritis of the hip or knee
* End-stage degenerative joint disease
* Eligibility for primary unilateral total or partial joint replacement surgery
* Pain level moderate to severe and at such a level as to require daily doses of an opioid analgesic medication

Exclusion Criteria:

* Has a life-long history of seizure disorder or epilepsy
* Had any of the following within the preceding 1 year: mild or moderate traumatic brain injury, stroke, transient ischemic attack, or brain neoplasm
* Had a severe traumatic brain injury within 15 years of screening (consisting of one or more of the following: brain contusion, intracranial hematoma, either unconsciousness or post traumatic amnesia lasting for more than 24 hours)
* Joint pain not associated with gout, fibromyalgia, rheumatoid arthritis, other autoimmune disease
* History of alcohol or drug abuse
* chronic hepatitis B and C or HIV, active hepatitis B and C within 3 months
* Severely impaired renal function or moderately to severely impaired hepatic function
* History of cancer within past 2 years
C: Inclusion Criteria:

* Clinical diagnosis of knee or hip osteoarthritis with history of pain at the reference joint for at least 3 months or clinical diagnosis of low back pain of benign origin for at least 3 months
* Must be dissatisfied with their current analgesic therapy (e.g. Non-steroidal anti-inflammatory drugs NSAIDS, COX-2 inhibitors, opioids, paracetamol/acetaminophen
* Have a pain intensity \>4 on Numerical Rating Scale

Exclusion Criteria:

* Life-long history of seizure disorder or epilepsy
* Any of the following within one year: mild/moderate traumatic brain injury, stroke, transient ischemic attack, and brain neoplasm
* Severe traumatic brain injury within 15 years (consisting of more than one of the following: brain contusion (injuries resulting in hemorrhage), intracranial hematoma, unconsciousness or post traumatic amnesia lasting for more than 24 hours) or residual sequelae suggesting transient changes in consciousness
* History of malignancy within past 2 years, with exception of a successfully treated basal cell carcinoma
* Presence of significant pain associated with conditions other than osteoarthritis or low back pain that could confound the assessment or self-evaluation of pain
D: 40 years and above, both genders, who have clinical and radiographic osteoarthritis symptomatic for at least six months.

Answer: A