Clinical trial: Study to Assess the Effect of E-OA-07 on Acute Pain Response in Subjects Suffering From Knee OA (NCT02417506)

Eligibility criteria:
Inclusion Criteria:

          -  Ambulatory adults of either sex aged 40 to 60 years.

          -  Subjects with moderate OA of the knee, which can be clinically, categorized as ARA
             functional Class II and III with radiological confirmation of Kellgren Lawrence Grade
             II and III. (incase of bilateral OA, the knee with the more severe symptoms will be
             defined as index joint)

          -  Subjects with OA in a flare state at the baseline defined by one of following category
             of flare:

        In subjects who have been receiving non steroidal anti-inflammatory drugs (NSAIDs) or
        analgesic therapy for their OA, flare will be defined as having at least two of the
        following three criteria while comparing screening to baseline:

          1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥
             40 mm;

          2. Increase of ≥ 1 grade in the patients global assessment of arthritis;

          3. Increase of ≥ 1 grade in the physician's global assessment of arthritis;

        In subjects who are not receiving NSAID or analgesic therapy , an OA flare state will be
        defined as having at least two of the following three criteria

          1. Subject's assessment of arthritis pain VAS walking on a flat surface at baseline of ≥
             40 mm

          2. Patient's global assessment of arthritis of ''poor''; very poor

          3. Physician's global assessment of arthritis of ''poor''; very poor

        Exclusion Criteria:

          -  Subjects with any form of arthritis other than osteoarthritis.

          -  Administration of intra-articular or oral steroids in the past 3 month or intra
             articular hyaluronic acid in the last 9 months or parenteral use of NSAIDs

          -  History of major chronic hepatic, cardiovascular, neurological or immunosuppressive
             conditions or the presence of any infections

          -  Subjects with localized trauma to the lower limb

          -  Had received oral, intramuscular, or intra-articular corticosteroids within 8 weeks,
             or intra-articular hyaluronic acid in the index joint within 6 months of study drug
             administration;

          -  Subjects on nutritional supplement or herbal product since last one month

          -  Subjects otherwise judged by the investigator to be inappropriate for inclusion in 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 40 Years old.
Subject must be at most 60 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