Clinical trial: A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of JNJ-39439335 in Patients With Osteoarthritis (NCT01343303)

Eligibility criteria:
Inclusion Criteria:

          -  Nonsmoker >= 6 months prior to first dose

          -  body mass index (BMI) <= 36 kg/m2

          -  Meet American College of Rheumatology (ACR) clinical classification criteria for
             osteoarthritis of knee by meeting at least 3 of the following: age > 50, morning
             stiffness < 30 minutes, crepitus on active motion, bony tenderness, bony enlargement,
             no palpable warmth of synovium

          -  Has Functional Class I-III osteoarthritis (OA) of knee with continuing OA-knee joint
             pain >= 5 days/week x 3 months prior to screening, and has been taking a non-opioid
             analgesic for OA knee pain daily for >=5 days prior to screening with benefit

          -  Otherwise healthy based on physical exam, medical history, vital signs, 12-lead
             electrocardiogram (ECG), can clinical laboratory tests

          -  Women must be postmenopausal or surgically sterile.

        Exclusion Criteria:

          -  Oral temperature >37.5 deg C at Screening or Day -1

          -  Failure of burn prevention measures quiz at Screening

          -  patients with occupations or hobbies in which they are routinely exposed to situations
             in which they could sustain burns

          -  orthopedic and/or prosthetic device on target knee joint

          -  Significant pain outside the target knee, including significant hip or back pain
             (bilateral knee OA is permitted)

          -  Unable to discontinue prior analgesic medications/non-steroidal antiinflammatory drugs
             (NSAIDS) other than paracetamol during the study

          -  Surgical intervention for any pain within 3 months prior to screening or has plans for
             surgical intervention while in the study

          -  History of prior diagnosis of inflammatory arthritis (including rheumatoid arthritis)

          -  Treatment with local corticosteroid injections or viscosupplementation in target
             joint, or use of oral or intramuscular corticosteroids, within 3 months prior to
             Screening

          -  History of active peptic ulceration, active dyspepsia, gastrointestinal bleeding,
             Crohn's disease, ulcerative colitis, chronic diarrhea esophageal, and gastric or
             duodenal ulcer within 3 months prior to screening or any other condition, which in the
             Investigator's opinion, precludes use of an NSAID.
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.
Subject must be at most 65 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