EFFICACY AND TOLERABILITY OF CHONDROITIN SULPHATE 1000MG, TWICE DAILY IN PATIENTS WITH SYMPTOMATIC KNEE OSTEOARTHRITIS
- Conditions
- Symptomatic knee osteoarthtitisMedDRA version: 12.0Level: LLTClassification code 10023476Term: Knee osteoarthritis
- Registration Number
- EUCTR2009-014516-35-BE
- Lead Sponsor
- PIERRE FABRE MEDICAMENT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 460
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
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 24 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 laboratory test results out of acceptable ranges and considered as clinically significant by the investigator performed at screening
- 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:
- patie
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 %),;Secondary Objective: - To assess the efficacy over 12 months on :<br>*Patient’s and investigator’s global assessment of the disease status<br>*Consumptions of analgesic medication (including NSAIDs)<br>*Improvement in the patient's health related quality of life<br>*Pain relief and functional improvement<br><br>- To evaluate :<br>*Safety and tolerability of the studied product over 12 months<br>*Structural changes over 12 months<br>*Biological tolerance over 12 months<br>
- Secondary Outcome Measures
Name Time Method