Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

Randomised, Comparative, Double-blind, Parallel-group Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee

The primary objective of this study, comparing ART 44 to ART 50, will be the evaluation of digestive tolerability (and in particular of diarrhoea).

Inclusion Criteria:

• Female or Male, aged 40 to 80 years, outpatient;

• Presenting with internal femorotibial osteoarthritis:

  • Symptomatic for more than 6 months;
  • Meeting ACR clinical and radiological criteria;
  • Overall mean VAS score of knee pain in last 24 hours > 40 mm (with no NSAIDs for over 72 hours and no analgesics for over 24 hours);
  • Pain present for at least one day out of 2 in the month preceding enrolment;
  • Radiological stage II to III (Kellgren and Lawrence) (image less than 12 months old).

Exclusion Criteria:

• Associated predominant symptomatic femoropatellar osteoarthritis;
• Chondromatosis or villonodular synovitis of the knee;
• Paget's Disease.