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 67-year-old woman comes to the clinic due to recent episode of choking, dysphagia, and cough.  Her other medical problems include hypertension, dyslipidemia, and osteoarthritis.  She does not smoke or use alcohol. She lives with her husband and she is able to do her own daily activities. She used to teach elementary school. Blood pressure is 135/80 mm Hg.  The patient's breath smells bad. Other physical examinations are normal.  A barium swallow study reveals an abnormality in the upper esophagus with an outpouching at the junction of the lower part of the throat and the upper portion of the esophagus.

Patient description (patient's own words): I'm a 67-year-old lady, and I went to the clinic due to nonstop choking, difficulty swallowing, and coughing. I also suffer from hypertension, cholesterol, and osteoarthritis. I do not smoke or drink alcohol. I live with my husband, and we are independent retired elementary school teachers. During the exam, my blood pressure was 135/80 mm Hg. The doctor told me I had a smelly breath. How embarrassing! The rest of my physical exam was normal. I did a barium swallow test, which is an X-ray of my throat, which revealed a problem in the upper part of my esophagus, where there's a small pouch or bulge at the spot where my throat meets the esophagus.

Does the patient match the trial criteria? Contradiction