E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic Knee osteoarthritis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10031165 |
E.1.2 | Term | Osteoarthritis knee |
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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 |
To demonstrate non-inferiority of Structum® to Chondrosulf® on pain relief and functional improvement in patients with symptomatic knee OA over 24 weeks. |
|
E.2.2 | Secondary objectives of the trial |
To compare the efficacy of Structum® and Chondrosulf® on : -Patient’s and investigator’s global assessment of the disease status, -Consumptions of analgesic medication (including NSAIDs), -Improvement in the patient's health related quality of life, To assess safety of the studied products in patients with symptomatic knee OA. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be included in the trial, patients should fulfill the following criteria: -male or female between 50 and 80 years of age, -presenting with medial and/or lateral femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness < 30 minutes), +evolving for more than 6 months, +with a global pain score greater than or equal to 40 on a 100mm VAS, +with Lequesne Index greater than or equal to 7, +with a grade II or III according to the Kellgren and Lawrence radiological classification, on an antero-posterior weight-bearing X-ray image of both knees taken within the 12 months preceding inclusion, -having given their written consent to take part in the study, -covered by social security or a health insurance policy |
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E.4 | Principal exclusion criteria |
Patients fulfilling at least one of the following criteria cannot be included in the study: - Disease-related criteria: -isolated symptomatic femoropatellar osteoarthritis of the knee, -hemochromatosis, ochronosis or hemophilia, -Paget's disease of bone, chondromatosis or villonodular synovitis, -symptomatic hip OA homolateral to the target knee, -inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…), -Anticipated surgery of the knee during the course of the study. - Previous or concomitant treatment-related criteria: -patient taking a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulfate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion, -patient taking bisphosphonates or strontium ranelate in the 3 months preceding inclusion, -patient having received corticosteroid treatment by any administration route during the month preceding inclusion, -patient having received intra-articular steroid injection in the target knee in the 2 months preceding inclusion or patient having received intra-articular hyaluronic acid in the target knee in the 6 months preceding inclusion, -patient having taken NSAIDs in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 12 hours preceding inclusion, -patient having undergone surgery (osteotomy, extra-articular ligamentoplasty, knee replacement, etc.) on the target knee, -patient having undergone articular lavage of target knee in the 3 months preceding inclusion, -patient having experienced physiotherapy, reeducation, alternative medicine (mesotherapy, acupuncture) throughout the whole treatment period, -patient with a known allergy to the study medication or one of its constituents, -patient requiring regular or intermittent steroid therapy. - Patient-related criteria: -important genu varum or valgum > 8° (physiological angle including), -Body mass index (BMI) greater than or equal to 34, -immunocompromised patient or patient presenting with a serious or progressive disease (cardiac, pulmonary, hepatic, renal, hematological, neoplastic or infectious disease), -patient presenting with a severe acute or chronic disease which the investigator deems incompatible with study implementation, -patient presenting with a disease which the investigator considers likely to interfere with the study results or to expose the patient to additional risk, -patient liable not to comply with protocol instructions and/or with treatment, in the investigator's opinion, -patient having taken part in a clinical trial in the preceding 30 days or taking part in a trial at the time of inclusion, -patient linguistically or psychologically unable to understand and sign the consent form, -For women: +pregnant, breast feeding or likely to become pregnant during the time of the study +women with childbearing potential not using effective contraception (oral contraceptives, intrauterine device, tubal ligation or other efficient procedures), - Rescue medication-related criteria: -patient with hypersensitivity to acetaminophen / paracetamol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison between the L0023 and Reference groups of the mean variation of global pain score and Lequesne Index over 24 weeks |
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Health-related quality of life |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
double placebo controlled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
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.8.4.1 | Number of sites anticipated in Member State concerned | 120 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |