NCT01009671UnknownPhase 3
Randomised, Comparative, Double-blind, Parallel-group Study to Evaluate the Digestive Tolerability of ART44 Versus ART®50 in Patients With Osteoarthritis of the Knee
Laboratoires NEGMA0 sites210 target enrollmentStarted: November 2009Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Enrollment
- 210
- Primary Endpoint
- To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
ART 44
Experimental
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
Intervention: ART 44 (Drug)
ART 50
Active Comparator
Evaluation of safety and efficacy at D-8, D0, W2, W4 and W12
Intervention: ART 50 (Drug)
Outcomes
Primary Outcomes
To demonstrate the better digestive tolerability of ART44 versus ART 50 over a 1-month period, based on a clinically predetermined difference
Time Frame: Day 8, Day 0, Week 2, Week 4 and Week 12
Secondary Outcomes
- To compare the overall safety and efficacy of the two products(Day 8, Day 0, Week 2, Week 4 and Week 12)
Investigators
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