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

• Status: Unknown status
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoires NEGMA

Criteria

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.