Osteoarthritis of the knee Musculoskeletal Diseases Other arthrosis
Conditions
Interventions
Group Chondrosulf® 1 capsule (400mg Chondroitin) three times a day (t.i.d), i.e.1200mg/day
Group Structum®, : 1 capsule (500mg Chondroitin) two times a day (b.i.d), i.e.1000mg/day
Sponsors
Pierre Fabre Research Institute (Institut de Recherche Pierre Fabre) (France)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients aged from 50 to 80 years with symptomatic femorotibial knee OA fulfilling American College of Rheumatology (ACR) criteria for knee OA, with a Kellgren-Lawrence radiological grade II or III, a global pain score greater than or equal to 40 on a 100mm Visual Analogue Scale (VAS) and a Lequesne Index greater than or equal to 7
Exclusion criteria
Exclusion criteria: 1. Isolated symptomatic femoropatellar osteoarthritis of the knee 2. Symptomatic hip OA homolateral to the target knee 3. Inflammatory, infectious or metabolic arthritis 4. Bisphosphonates or strontium ranelate in the 3 months preceding inclusion 5. Corticosteroid treatment during the month preceding inclusion 6. Intra-articular steroid injection in the 2 months preceding inclusion 7. Intra-articular hyaluronic acid in the 6 months preceding inclusion 8. Non steroidal anti-inflammatory drugs (NSAIDs) in the 2 days preceding inclusion 9. Articular lavage of target knee in the 3 months preceding inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Two co-primary efficacy endpoints : 1. Mean variation of the global pain score (VAS) over 24 weeks 2. Mean variation of Lequesne Index over 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Responders (OARSI-OMERACT criteria) 2. Patient?s and investigator?s global assessment scores 3. Consumption of analgesics medication (including NSAIDs) 4. Quality of life assessment (SF12 & OAKHQOL) | — |
Countries
France
Outcome results
None listed