This multicenter, randomized, open-label, parallel-group, non-inferiority comparison study with an oral NSAID involved a total of 200 patients with knee OA. An independent, computer-generated randomization sequence was used to randomly assign patients in a 1:1 ratio to NSAIDs three times per day for five weeks (n = 100) or IA-HA once a week for five weeks (n = 100). The primary endpoint was the percentage change in the patient-oriented outcome measure for knee OA, the Japanese Knee Osteoarthritis Measure (JKOM) score. All patients were questioned regarding any adverse events during treatment. The full analysis set (FAS) was used for analysis. The margin of non-inferiority was 10%.
The investigators conducted a clinical examination comprising general examination and specific examination of the musculoskeletal system at inclusion, on day 0 and at the end of treatment (day 5). These examinations included feed intake, general behaviour, posture, lameness and pain on manipulation assessments and rectal temperature measurement. In addition, at the end of the treatment, the investigator evaluated the overall efficacy and palatability of the treatment. Diseases of the limbs, especially soft tissue injuries (contusions) and joint disorders (sprains and luxations) of less than 2 weeks duration were the most frequently diagnosed.