Clinical trial: Clinical Study of Artz in the Treatment of Knee Osteoarthritis (NCT02826031)

Eligibility criteria:
Inclusion Criteria:

          1. Adult Chinese subjects, at age≥18, either gender, diagnosed with osteoarthritis of the
             target knee and Kellgren-Lawrence (KL) classification Grade 1~3, as evidenced by X-ray
             examination in the last 3 months (mild to moderate narrowing of joint space and / or
             marked osteophytes of tibiofemoral joint space)

          2. Persist pain of the target knee after exercise, weight loss and physical therapy;

          3. A baseline WOMAC A1 score for the target knee rated at 40-90mm (moderate to severe
             walk-associated pain) on 100mm Visual analogue scale(VAS); Able to understand and sign
             the Informed Consent Form (ICF) that has already been approved by the Independent
             Ethics Committee (IEC) Note: the informed consent may also be given by the duly
             authorized representative of the subject.

        Exclusion Criteria:

          1. A diagnosis of bilateral knee osteoarthritis;

          2. Clinically significant (requiring surgery) valgus or varus deformity of the knee
             joint, ligamentous laxity or unstable meniscus;

          3. Complicated by inflammation or any other disease /condition (e.g., rheumatic
             arthritis, metabolic bone disease, psoriasis, gout, pseudogout, chondrocalcinosis,
             etc.) that may affect the knee joint;

          4. A history of septicemia, clinically considered sub-acute infection of the target knee
             joint;

          5. A history of surgery on the target knee (in the last 6 months);

          6. A history of asthma, urticaria or allergy after use of aspirin or other non-steroidal
             anti-inflammatory drugs (NSAIDs);

          7. Severe hepatic or renal disease or hepatic /renal failure;

          8. Any unscheduled surgery on the lower limb;

          9. Clinically significant lower venous or lymphatic obstruction;

         10. Clinically significant obvious exudation or inflammation of the target knee;

         11. Skin disorders or infection at the injection site;

         12. Pregnant or lactating women;

         13. Known allergy to guanylin and / or any active ingredient or excipient of hyaluronic
             acid-based injection / diclofenac sodium;

         14. Treatment with any hyaluronic acid (HA) or its derivatives for the target knee within
             six months before this trial;

         15. Intra-articular (IA) injection of steroids into the target knee within 3 months before
             this trial;

         16. Presence of any contraindication to IA injection, e.g., patients who are receiving
             anti-coagulation therapy or clinically have potential coagulation disorders (e.g.,
             hepatic disease);

         17. Presence of any clinically significant disease (e.g., significant mental or nervous
             disorders, alcohol/drug abuse), unstable/poorly controlled diseases, or other factors,
             which may affect their evaluation or participation in this study in the investigator's
             judgment

         18. Perioperative pain associated with coronary artery bypass surgery (CABG);

         19. A history of gastrointestinal bleeding or perforation following use of NSAIDs;

         20. Presence of active gastrointestinal ulcer /bleeding, or a past history of recurrent
             ulcer/bleeding; Chief complaint complicated by pain beyond the target knee,
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.


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