Clinical trial: Long-Term Analgesic Efficacy And Safety Of Tanezumab Alone Or In Combination With Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Versus NSAIDs Alone In Patients With Osteoarthritis Of The Knee Or Hip (NCT00809354)

Eligibility criteria:
Inclusion Criteria:

          -  Osteoarthritis of the knee or hip according to ACR criteria with Kellgren-Lawrence
             x-ray grade equal to, or greater than, 2.

          -  Patients must be experiencing some benefit from their current stable dose regimen of
             oral NSAID therapy of either naproxen 500-1000 mg/day or celecoxib 200 mg/day (either
             100 mg BID or 200 mg QD) and be tolerating their NSAID regimen.

          -  Pain level and function levels as required by the protocol at Screening and Baseline.

          -  Willing to discontinue all non-study pain medications for osteoarthritis except rescue
             medication (acetaminophen) and not use prohibited pain medications throughout the
             duration of the study except as permitted per protocol.

          -  Willing and able to comply with lifestyle guidelines, scheduled visits, treatment
             plan, laboratory tests and other study procedures.

        Exclusion Criteria:

          -  Pregnant women.

          -  BMI greater than 39.

          -  Fibromyalgia, regional pain caused by lumbar or cervical compression with
             radiculopathy or other moderate to sever pain that may confound assessments or
             self-evaluation of the pain associated with OA.

          -  Signs and symptoms of clinically significant cardiac disease with 6 months prior to
             screening.

          -  Diagnosis of TIA within 6 months prior to screening or diagnosis of stroke with
             residual deficits that would preclude completion of required study activities.

          -  History, diagnosis, signs or symptoms of clinically significant neurological and/or
             psychiatric disease/disorder.

          -  At Screening: uncontrolled hypertension, hemoglobin A1c greater than or equal to 10%,
             ALT or AST greater than or equal to 3X upper limit of normal, creatinine exceeding 1.7
             mg/dL (men) or 1.5 mg/dL (women).

          -  Patients on warfarin or other coumadin anticoagulant therapy and/or lithium therapy
             within 30 days prior to screening.

          -  Known hypersensitivity to NSAIDs or cyclooxygenase inhibitors.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment