Efficacy and Safety of Piascledine 300 versus Chondroitin Sulfate in a 6 Months Treatment plus 2 Months Observation in Patients with Osteoarthritis of the Knee

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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, and/or evaluate on at least 2 items among 5 items in the A-section of the WOMAC-index.
·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

·Known chondrocalcinosis of the joints
·Symptomatic femoro-patellar arthrosis
·Ochronosis or haemochromatosis
·Morbus Paget, Chondromatosis, Villo-nodular synovitis
·Haemophilia
. Septic arthritis
. Inflammatory joint disease
. Gout
. Pseudo-gout
. Articulare farcture
. Acromegaia
. Wilson-disease
. Collagene gene mutations
·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 with lipid metabolism disorders
. 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
Patient having femoro-tibial OA of the knee

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in the WOMAC index from baseline to therapy end;Secondary Objective: Pain on active movement<br>Pain at rest<br>Lequesne index<br>Overall assessment of osteoarthritis of the knee<br>Overall assessment of efficacy<br>Consumption of analgesics;Primary end point(s): Changes in the WOMAC index from baseline to therapy end

Secondary Outcome Measures

Name	Time	Method

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