EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 460

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 < 30 minutes)
- evolving for more than 6 months
- with a Womac pain score greater than or equal to 45 on a 100mm VAS
- patients taking analgesic medications for at least 3 months prior to inclusion and dissatisfied with their current therapy
- with a grade II or III according to the Kellgren and Lawrence radiological classification(1) on a posterio-anterior weight-bearing X-ray image of both knees performed at screening visit

*having given their written consent to take part in the study

*covered by social security or a health insurance policy (if required by local requirements).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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:
opregnant, breast feeding or likely to become pregnant during the time of the study
owomen 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method