Table 1 Additional inclusion and exclusion criteria

Pain intensity of 20 mm or more by VAS in the previous 48 hours when walking on a flat surface;

At least grade II to III on the Kellgren-Lawrence scale by an X-ray taken within 6 months;

And reluctant to continue on previous drug but willing to change drug treatment.

Exclusion criteria

Patients presenting with any of the following will be excluded from the study.

Grade I or Grade IV severity of the index knee based on the Kellgren and Lawrence radiographic criteria as applicable;

Use of intra-articular injections or arthroscopy of the index knee within 3 months prior to screening;

Evidence of crystalline-induced synovitis in the index knee;

History, physical examination, or radiographic results suggestive of acute inflammatory arthritis, rheumatoid arthritis, psoriatic arthritis, septic arthritis, gout, pseudogout, fibromyalgia, systemic lupus erythematosus, or other types of inflammatory arthritis of the index knee;

Pain in either knee of neurologic origin;

Signs of clinically important active inflammation in the index knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits;

History of acute inflammatory arthritis or pseudogout of the study joint;

Cancer/metastatic disease;

Systemic or intra-articular corticosteroid use within 60 days of the Screening visit;

Known sensitivity to any of the ingredients listed in the treatments under investigation;

Significant medical and skin conditions which, in the opinion of the investigator, will interfere with study participation and patch adherence;

Replacement of the knee joint.