A multicentre, comparative, randomised, double-blind clinical trial on the equivalence of the efficacy and the safety of CHONDROSULF® 1200 mg, oral gel in sachet, once daily, versus CHONDROSULF® 400 mg, capsules, 3 capsules per day, and a placebo in the treatment of knee osteoarthritis.”
- Conditions
- Knee osteoarthritis
- Registration Number
- EUCTR2005-005163-29-BE
- Lead Sponsor
- IBSA (Institut Biochimique SA)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 336
•Patients of either sex, aged = 45 years
•Patients affected by knee osteoarthritis defined according to Altman’s criteria (ACR), in most cases internal tibio-femoral osteoarthritis, without excluding coeducational forms; in case of a bilateral gonarthrosis, evaluation of the most symptomatic knee, always the same
•Knee osteoarthritis evolving for more than 6 months
•Patients suffering from regular pain and functional disorders from at least 3 months
•Accomplishing a score = 7 of Lequesne index for the knee osteoarthritis
•Assessing pain on Huskisson’s VAS (Visual Analogic Scale) = 40mm
•With radiography dated less than one year showing a remaining articular joint space
•Without such an axial disorder to justify an osteotomy
•Women taking contraceptive measures if not in menopause
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
•Insulated or prevalent femoro-patellar osteoarthritis: if attack is linked; inclusion is possible if femoro-patellar attack is only radiological and if the clinical symptomatology is the one of the femoro-tibial osteoarthritis
•Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
•Osteoarthritis with hydarthrosis requiring a puncture or an infiltration
•Important genu varum or valgum > 8° (physiological angle including)
•Knee joint surgery in the last 3 months (eg. chondroscopy, arthroscopy)
•Viscosupplementation, tidal lavage in the last 6 months
•Arthritis and metabolic arthropathies, Paget’s illness
•Having consumed:
- basic treatment of arthritis with SYSADOA (chondroitin sulphates, glucosamine sulphates, diacerrhein, hyaluronic acid) in the last 3 months
-treatment with corticoids, by any administration route during the last month
-any medication having an influence on pain:
?hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
?paracetamol in the 10 hours* preceding the inclusion
•Having experienced physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) throughout the whole treatment period
•Presenting a lactose** intolerance
_______________________________
* Necessary wash out period for the elimination of paracetamol
** Placebo's excipient
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the equivalence of the efficacy of CHONDROSULF 1200 mg oral gel in sachet, once daily, versus CHONDROSULF 400 mg 3 capsules per day and a placebo for 91 days.<br>;Secondary Objective: To confirm the equivalence of the safety of CHONDROSULF 1200 mg oral gel in sachet, once daily, versus CHONDROSULF 400 mg 3 capsules per day and a placebo for 91 days.<br>;Primary end point(s): Reduction of the algo-functional index of Lequesne for knee osteoarthritis between day 0 and day 91.
- Secondary Outcome Measures
Name Time Method