Clinical trial: A Phase 1/2A, Single Dose Study Of PF-04383119 In Japanese Patients With Moderate To Severe Pain From Osteoarthritis Of The Knee (NCT00669409)

Eligibility criteria:
Inclusion Criteria:

          -  Japanese Male or female, Age 35-65 (Part 1), Age 35-75 (Part 2)

          -  Diagnosis of osteoarthritis (OA) of the knee based on American College of Rheumatology
             criteria

          -  Knee pain, and radiographic evidence of knee OA (Kellgren-Lawrence x-ray grade ≥2)
             obtained within 1 year of enrollment

          -  At least one of the following: age >50, morning stiffness <30 minutes in duration,
             crepitus, and OA of the knee must involve the index tibiofemoral joint and must have
             present for at least 6 months

          -  Patients who meet at least one of the following: unwilling to take non-opiate pain
             medications, or for whom non-opiate pain medications have failed, or are candidates
             for or seeking invasive interventions such as intraarticular injections, knee
             arthroplasty, or total knee surgery

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

        Exclusion Criteria:

          -  Diagnosis or history of RA, any inflammatory arthritis, gout, Paget's disease or any
             other disease that in the Investigator's opinion would interfere with the assessment
             of pain and other symptoms of OA

          -  Patients with regional pain syndromes suggestive of fibromyalgia or regional pain
             caused by lumbar or cervical compressions with radiculopathy or at risk of developing
             radiculopathy.

          -  Diagnosis or history of fibromyalgia

          -  Planned surgical procedure during the duration of the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 35 Years old.
Subject must be at most 75 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment