Symptomatic knee osteoarthtitis MedDRA version: 12.0 Level: LLT Classification code 10023476 Term: Knee osteoarthritis
Conditions
Interventions
Trade Name: STRUCTUM
Product Code: L0023 GE
Pharmaceutical Form: Capsule*
INN or Proposed INN: Chondroitin sulfate sodium
CAS Number: 9082-07-09
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
PIERRE FABRE MEDICAMENT
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be included in the trial, patients should fulfill the following criteria: *male or female between 50 and 75 years of age *presenting with medial femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients fulfilling at least one of the following criteria cannot be included in the study: * Disease-related criteria: - isolated symptomatic femoropatellar osteoarthritis or isolated lateral femorotibial OA of the knee - Paget's disease of bone, chondromatosis or villonodular synovitis - symptomatic hip OA - inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…) - hemochromatosis, ochronosis or hemophilia - history of disease (except OA) which the investigator considers likely to interfere with the assessment of the functional disability - Anticipated surgery of the knee during the course of the study * Previous or concomitant treatment-related criteria: - patient having taken a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulphate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion - patient having taken bisphosphonates or strontium ranelate in the 3 months preceding inclusion - patient having received any systemic corticosteroid treatment by any administration route during the month preceding inclusion - patient having received intra-articular steroid injection in the target knee in the 2 months preceding inclusion or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding inclusion - patient having taken NSAIDs (except aspirin up to 325 mg/day for cardiovascular prophylactic) in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 12 hours preceding inclusion - patient having undergone surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) on the target knee - patient having undergone articular lavage of target knee in the 3 months preceding inclusion - patient with a known allergy to the study medication or one of its constituents - patient requiring regular or intermittent steroid therapy. * Patient-related criteria: - Body mass index (BMI) greater than or equal to 35 - immunocompromised patient or patient presenting with a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic or infectious disease) - patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation - patient presenting with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk - patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion - patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion - patient linguistically or psychologically unable to understand and sign the consent form - For women: o pregnant, breast feeding or likely to become pregnant during the time of the study o women with childbearing potential not using effective contraception (oral contraceptive formulations, intrauterine device, tubal ligation or other efficient procedures) * Rescue medication-related criteria: - patient with hypersensitivity to paracetamol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To assess the efficacy over 12 months on : *Patient’s and investigator’s global assessment of the disease status *Consumptions of analgesic medication (including NSAIDs) *Improvement in the patient's health related quality of life *Pain relief and functional improvement - To evaluate : *Safety and tolerability of the studied product over 12 months *Structural changes over 12 months. ;Main Objective: To assess the efficacy of chondroitin sulfate 1000 mg twice daily on pain relief and additionally functional improvement in patients with symptomatic knee OA at 6 months.;Primary end point(s): Comparison at month 6 between the L0023 GE and Reference groups of the percentage of pain responders (patients with reduction of Womac pain score from baseline of = 30 %), and additionally of function responders (patients with reduction of Womac function score from baseline of = 20 %), | — |
Countries
Belgium, Czech Republic, Estonia, France, Lithuania
Outcome results
None listed