Prospective multicentric open clinical study comparing the efficacy and safety of piascledine 300 plus standard treatment versus standard treatment only in patients with osteoarthritis of the knee - PRAGMA-PIAS STUDY

• Conditions: Osteoarthritis of the knee

• Registration Number: EUCTR2007-004973-25-PL
• Lead Sponsor: aboratoire Expanscience

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04-07
• Last Update Posted: 23 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 300

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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<br>To evaluate the Quality of Life<br>To evaluate the consumption of rescue medication;Primary end point(s): Number of patients not requiring NSAIDs from Visit 2 (day 45)