Clinical trial: Efficacy Study of "Go On" in Magnetic Resonance Imaging (MRI) Improvement in Osteoarthritis (OA) Knee (NCT00750724)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects who are capable of giving written informed consent, which includes compliance
             with the requirements and restrictions listed in the consent form.

          -  Ambulatory non pregnant females and males 40-<80 years of age.

          -  Subjects who withdraw pain medication or nutritional supplements for symptom relief
             for OA hand for a total of at least 30 days before screening visit 0.

          -  Pain at or below 40 mm on a 100 mm VAS in the index knee joints.

          -  A documented diagnosis of OA of the knee joint, or meeting American College of
             Rheumatology (ACR) clinical criteria for classification of idiopathic (primary) OA for
             at least 6 months prior to screening.

          -  Subject has been documented radiographic evidence of OA of the knees from the
             screening Visit radiograph of grade 2 or 3 according to Kellgren and Lawrence
             Radiographic Grading.

          -  Subject has no any contraindication for MRI

          -  Subject is able to understand and complete pain/function, global arthritis evaluation,
             and health outcome assessment.

        Exclusion Criteria:

          -  Subjects with history of hypersensitivity to hyaluronate.

          -  Subjects with skin lesion at the knee joint.

          -  A history of knee surgery within 6 months prior to screening V0.

          -  Significant prior injury to the knee joint within 12 months prior to screening V0.

          -  Disease of the spine or other lower extremity joints of sufficient degree to affect
             the knee joint.

          -  Treatment with other drugs potentially affecting bone or cartilage metabolism as
             described below:

          -  chronic systematic corticosteroids

          -  Diacerin or glucosamine treatment within the last 12 months.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 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