Osteoarthritis of the knee
Conditions
Interventions
Trade Name: Piascledine
Product Name: Piascledine 300
Pharmaceutical Form: Capsule*
Trade Name: Piascledine
Product Name: Piascledine
Pharmaceutical Form: Capsule*
Sponsors
Laboratoire Expanscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female of male outpatients aged 45 years or more suffering from femoro-tibial osteoarthritis of the knee uni- or bi-compartmental, uni- or bilateral and/or femoro-patellar, ptrogressing for at least 6 months, with overall pain assessed between 25 and 50 mm (VAS) in spite of daily intake of Diclofenac 75 to 150 mg/day or equivalent for at least 10 days per month and for at least 3 months prior to inclusion 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Articular chondrocalcinosis known in advance or defined by the presence of a calcic edging on at least one femoral-tibial articular space Known symptomatic hip osteoarthritis (coxarthrosis) homolateral to the osteoarthritis of the knee Osteoarthritis of the knee indicating for a surgical intervention during or before the trial or Treatment with SYSADOA, hyaluronic acid injections within 3 months before study start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Piascledine 300 mg in the treatment of ostoarthtitis of the knee by comparing the use of NSAIDs in 2 groups: Piascledine associated with standard NSAID treatment versus standard NSAID treatment alone;Secondary Objective: To evaluate the saftety of Piascledine To evaluate the Quality of Life To evaluate the consumption of rescue medication;Primary end point(s): Number of patients not requiring NSAIDs from Visit 2 (day 45) | — |
Countries
Poland
Outcome results
None listed