Clinical trial: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee (NCT00689273)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female of any race, between the ages of 18 and 75 years inclusive

          -  Female subjects must be of non-childbearing potential and have a negative pregnancy
             test at Screening.

          -  Osteoarthritis of the knee of at least 6 months duration and meeting the American
             College of Rheumatology Criteria. For radiographic criteria the Xray must have been
             taken within the last 5 years. If none is available, one should be taken and the
             diagnostic criteria confirmed prior to randomization.

          -  Willing and able to discontinue all current analgesic therapy, including OTC pain
             medications and topical analgesics for OA pain, for period beginning with washout
             phase (lasting 2 days or 5 half-lives of patient's current analgesic medication prior
             to Day -6) and continuing for the entire duration of study. As an exception,
             acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the
             discretion of a qualified member of the study team.

          -  If a subject has evidence or a history of clinically significant endocrine, pulmonary,
             gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological
             disease, the investigator must confirm that the disease is stable (at least 4 weeks)
             and under control.

          -  QTc interval ≤450 msec and a PR interval ≤210 msec on Screening ECG.

        Exclusion Criteria:

          -  Pregnant or lactating females, and females of childbearing potential.

          -  Arthroscopy performed on index knee within 1 year of screening.

          -  Active depression as defined by or meeting The Hospital Anxiety and Depression Scale
             (HADS) of >10.

          -  Unwillingness to refrain from consumption of grapefruit or grapefruit juice from 7
             days prior to the first dose of study medication until completion of the study.

          -  First degree or higher AV block, defined as PR interval >210 msecs, bundle branch
             block, fascicular block or intraventricular conduction delay or clinically relevant
             abnormality on screening ECG.

          -  Active malignancy of any type or history of a malignancy within 10 years (with the
             exception of subjects with a history of treated basal cell carcinoma).

          -  Symptomatic OA of the hip ipsilateral to index knee which the patient considers more
             painful than the knee.

          -  Use of prohibited medications as listed below, in the absence of appropriate washout
             period. The following analgesic agents must be discontinued within 48 hours or 5 half
             lives of the analgesic being washed out prior to the baseline period (Day -6 to Day
             0);

               -  NSAIDs and selective COX-2 inhibitors;

               -  Acetaminophen ( as an exception acetaminophen may be used for non-joint related
                  pain at doses ≤1g/day);

               -  Opioids.

               -  Oral or I/M corticosteroids within 4 weeks prior to screening. I/A steroids
                  within 12 weeks prior to baseline in study joint or any other joints within 4
                  weeks prior to baseline, or I/A hyaluronic acid within 24 weeks prior to
                  baseline;

               -  Use of concomitant medications that are CYP3A inhibitors or CYP3A inducers, or
                  that are P-glycoprotein substrates within 48 hours or 5 half lives prior to
                  baseline.
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 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? Contradiction