Osteoarthritis of the Knee
Conditions
Interventions
Trade Name: Piascledine®
Product Name: Piascledine®
Pharmaceutical Form: Capsule*
Other descriptive name: unsaponifiable fraction of avocado oil, unsaponifiable fraction of soy oil
Concentration unit:
Sponsors
Laboratoires Expanscience
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: · Female or male outpatients aged 45 years or more. Patients complying with the clinical and radiological criteria of the American College of Rheumatology of knee osteoarthritis · Duration of the disease longer than 6 months · Pain and functional discomfort over 1 month during the last 3 months · Pain on movement and/or pain at rest in the last 48 hours at least 40 mm evaluated on a VAS · No intake of analgesics for 48 hours · No intake of NSAID for 5 days · Lequesne index between 5 and 13 (moderate to very severe arthrosis) · Radiological characterisation of stage I, II or III of the modified Kellgren and Lawrence classification scale on a frontal image of extended knee, on both knees , the image being not older than 6 months · Patient capable of following the instructions of the study · Signed informed consent following information provided by the investigator 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: · Known chondrocalcinosis of the joints · Symptomatic femoro-patellar arthrosis · Ochronosis or haemochromatosis · Morbus Paget, Chondromatosis, Villo-nodular synovitis · Haemophilia · Osteoarthritis of the hip located at the site of the evaluated knee · Osteoarthritis of the knee that may require surgical intervention during the planned duration of the study. · Body-mass index >35 . Treatment with NSAID within 5 days or an analgesic within 48 hours before inclusion · Treatment with SYSADOA within 3 months prior to inclusion · Treatment with corticoids within one month prior to inclusion · Intra-articular injection of corticoids, hyaluronic acid into the knee within 3 months prior to inclusion · Treatment with pulsed electromagnetic field within 3 months prior to inclusion · Synoviorthesis within 3 months prior to inclusion · Operations (osteoctomy, meniscectomy) on the evaluated knee · Diseases requiring the intermittent taking of corticoids (e.g. asthma) . Patients who had already treatment with Piascledine® or Chondroitin-sulfate within the last 3 months · Patients with serious evolutive heart condition, pulmonary, renal, hepatic, haematological, neoplastic or infectious diseases · Patients with a known allergy to one of the components of the used drugs (test, comparative and/or rescue medication) · Patients with leucopenia suffering from a serious hereditary disease · Patients being pregnant or not having efficient contraception at the time of inclusion · Patients having had an intricacy following an accident or net psychalgic component · Patients already included in another therapeutic study · Patients who already participated in a study in the month preceding the inclusion · Patient incapable of keeping a self-assessment diary
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Changes in the WOMAC index from baseline to therapy end;Secondary Objective: Pain on active movement Pain at rest Lequesne index Overall assessment of osteoarthritis of the knee Overall assessment of efficacy Consumption of analgesics;Primary end point(s): Changes in the WOMAC index from baseline to therapy end | — |
Countries
Czech Republic, Hungary
Outcome results
None listed