E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Osteoarthritis of the Knee | |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | Changes in the WOMAC index from baseline to therapy end | |
E.2.2 | Secondary objectives of the trial | Pain on active movement Pain at rest Lequesne index Overall assessment of osteoarthritis of the knee Overall assessment of efficacy Consumption of analgesics | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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 | |
E.4 | Principal 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 | |
E.5 End points |
E.5.1 | Primary end point(s) | Changes in the WOMAC index from baseline to therapy end | |
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 | The trial involves single site in the Member State concerned | No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 | Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |