E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Osteoarthritis of the Knee |
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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 |
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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 |
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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 |
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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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in the WOMAC index from baseline to therapy end |
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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 |
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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 |