Clinical trial: Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee (NCT03561779)

Eligibility criteria:
Inclusion Criteria:

        [Visit 1, 2 Inclusion Criteria]

          1. Males or Females 40 years and older

          2. According to the clinical diagnosis standard of the American College of Rheumatology
             (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to
             over 3 conditions of followings.

        1) Over 50 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active
        motion 4) 4 bony tenderness 5) Bony enlargement 6) Nopalpable warmth of synvium 3. Within 6
        months from screening visit, someone who diagnosed with Kellgren & Lawrence Grade I~III by
        the radioactive examination.

        4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the
        single or both sides of the osteoarthritis is over 40mm 5. Patient (No-responder) who has
        experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.

        6. Patient who can walk by themselves without helper like cane or walker etc. (If the
        patient who has used helper routinely from previous 6 months, evaluating the patient
        including the helper is possible. In this case, patient needs to use same helper
        continuously by end of the clinical trial test.) 7. Patient who agrees to participate in
        this clinical trial by themselves.

        [Visit 6, 7 Inclusion criteria] 1. According to the clinical diagnosis standard of the
        American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of
        osteoarthritis, who corresponds to over 3 conditions of followings.

          1. Over 50 years of age

          2. Less than 30 minutes of morning stiffness

          3. Crepitus on active motion

          4. 4 bony tenderness

          5. Bony enlargement

          6. Nopalpable warmth of synvium 2. At Re-screening visit, someone who diagnosed with
             Kellgren & Lawrence Grade I~III by the radioactive examination.

        3. Patient who can walk by themselves without helper like cane or walker etc. (If the
        patient who has used helper routinely from previous 6 months, evaluating the patient
        including the helper is possible. In this case, patient needs to use same helper
        continuously by end of the clinical trial test.) 4. Patient who are confirmed for Responder
        by efficacy at visit 5.

        Exclusion Criteria:

          1. Someone who has BMI≥32kg/m² at the screening visit.

          2. Patient who has an experience dosing psychoactive drug, narcotic analgesic which can
             have an effect on pain sense over 3 months habitually.

          3. Patient who has been administrated gastrointestinal drug(for example H₂-blockers,
             misoprostol or proton pump inhibitors) regularly, who can't stop injecting for
             clinical study period.

          4. Patient has attended abnormal values from screening test(2 times excess at upper limit
             of the normal values at ALT, AST, BUN, Serum Creatinine).

          5. Patient who has rheumarthritis or other inflammatory metabolic arthritis.

          6. Patients having serious gastrointestinal, liver, renal, heart disease.

          7. When the inflammatory disease is occurred on joint area to patient like septic
             arthritis.

          8. Patients having skin ailment at the injecting site of the joint region.

          9. Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis
             or systemic disease.

         10. Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc
             herniation.

         11. Poly-articular patients who have suffered seriously by osteoarthritis at other parts
             affect judge of the knee joint pain.

         12. Patients who diagnosed clear interval disappearance at the knee joint by X-ray.

         13. Patients who were administrated below drugs before baseline visit. 1) Patients who
             were injected HA at the target knee joint or other parts of knee joint in recent 9
             months.

        2) Patients who were injected steroids into the intra-articular knee joint in recent 3
        months 3) Patients who were administrated steroids systemically by the oral medication
        (But, except inhalation) 4) Patients who were administerated Osteoarthritis nutrition such
        as glucosamine/chondroichin sulfate or physical therapy or herbal remedy(acupuncture,
        yellowish swelling, moxa cautery) for the purpose of pain relief in recent 2 weeks 5)
        Patients who have administerated steroid/No-steriod NSAIDs or other pain relief drugs
        (patch or other external medicine) in recents 2 weeks except Acetaminophen or below
        300mg/day of Asprin 14. Patients who have joint effusion trouble were judged as a positive
        by tests like Patella tap test.

        15. Patients who have target knee joint gotten surgical operation history including
        Arthroscopy within past one year (In case of having other side of knee joint or hip joint
        gotten surgical operation history, excepting the patients if there is possibility which can
        influence the target knee joint's appraisal.

        16. Patients who have an operation history about target knee joint. 17. Patients who do the
        height weight aerobic exercise or anaerobic exercise. 18. Patients who need to be
        administrated anticoagulant agent together(But, except 300mg daily dose aspirin) 19.
        Patients who have hypersensitivity history about Investigational Product. 20. In the midst
        of women in their childbearing years, patients who disagree to do * contraception by
        medically permitted method for 12 weeks from administrating investigational product.

          -  The contraception by medically permitted method: Condom, In case of using injection or
             insertion, In case of installing a intrauterine contraception device etc.

             21. Pregnant and lactating women 22. Patients who were injected other investigational
             product over a time within 30 days before participated in this clinical trail.

             23. Besides that, the patients who have difficulty to be participated in this clinical
             trial continuously by Principle Investigator (PI)'s decision.

          -  Exclusion criteria for Re-injection is except for 13-1) Re-injection date is followed
             by visit 7.
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.


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