Symptomatic Knee osteoarthritis MedDRA version: 9.1 Level: LLT Classification code 10031165 Term: Osteoarthritis knee
Conditions
Interventions
Trade Name: Structum
Product Name: Structum
Product Code: L0023 GE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Chondroïtine sulfate sodique
CAS Number: 9082-07-9
Concentration unit: mg mil
Sponsors
Pierre Fabre Médicament
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 80 years of age, -presenting with medial and/or lateral 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 of the knee, -hemochromatosis, ochronosis or hemophilia, -Paget's disease of bone, chondromatosis or villonodular synovitis, -symptomatic hip OA homolateral to the target knee, -inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…), -Anticipated surgery of the knee during the course of the study. - Previous or concomitant treatment-related criteria: -patient taking a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulfate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion, -patient taking bisphosphonates or strontium ranelate in the 3 months preceding inclusion, -patient having received 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 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 having experienced physiotherapy, reeducation, alternative medicine (mesotherapy, acupuncture) throughout the whole treatment period, -patient with a known allergy to the study medication or one of its constituents, -patient requiring regular or intermittent steroid therapy. - Patient-related criteria: -important genu varum or valgum > 8° (physiological angle including), -Body mass index (BMI) greater than or equal to 34, -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: +pregnant, breast feeding or likely to become pregnant during the time of the study +women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures), - Rescue medication-related criteria: -patient with hypersensitivity to acetaminophen / paracetamol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of Structum® to Chondrosulf® on pain relief and functional improvement in patients with symptomatic knee OA over 24 weeks.;Secondary Objective: To compare the efficacy of Structum® and Chondrosulf® 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, To assess safety of the studied products in patients with symptomatic knee OA.;Primary end point(s): Comparison between the L0023 and Reference groups of the mean variation of global pain score and Lequesne Index over 24 weeks | — |
Countries
France
Outcome results
None listed