Knee osteoarthritis
Conditions
Interventions
Product Name: CHONDROSULF 1200mg oral gel in sachet
Pharmaceutical Form: Oral gel
INN or Proposed INN: CHONDROITIN SULPHATES, sodium salt
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
IBSA (Institut Biochimique SA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ;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. ;Primary end point(s): Reduction of the algo-functional index of Lequesne for knee osteoarthritis between day 0 and day 91. | — |
Countries
Belgium
Outcome results
None listed