Clinical trial: Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee (NCT02554552)

Eligibility criteria:
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.

               -  Over 50 years of age

               -  Less than 30 minutes of morning stiffness

               -  Crepitus on active motion

               -  4 bony tenderness

               -  Bony enlargement

               -  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.

        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.

               -  Patients who were injected HA at the target knee joint in recent 9 months.

               -  Patients who were injected HA at other parts of the knee joint in recent 6
                  months.

               -  Patients who were injected steroids into the intra-articular knee joint.

               -  Patients who were administrated steroids systemically by the oral medication
                  (But, except inhalation)

         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. Patients who were injected other investigational product over a time within 30 days
             before participated in this clinical trail.

         22. Besides that, the patients who have difficulty to be participated in this clinical
             trial continuously by Principle Investigator (PI)'s decision.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 40 Years old.


Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment