E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Symptomatic knee osteoarthtitis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
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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 assess the efficacy of chondroitin sulfate 1000 mg twice daily on pain relief and additionally functional improvement in patients with symptomatic knee OA at 6 months. |
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E.2.2 | Secondary objectives of the trial |
- To assess the efficacy over 12 months 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 *Pain relief and functional improvement
- To evaluate : *Safety and tolerability of the studied product over 12 months *Structural changes over 12 months. *Biological tolerance over 12 months.
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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 75 years of age
*presenting with medial femorotibial OA of the knee fulfilling ACR criteria (knee pain + crepitus + morning stiffness < 30 minutes) - evolving for more than 6 months - with a Womac pain score greater than or equal to 45 on a 100mm VAS - patients taking analgesic medications for at least 3 months prior to inclusion and dissatisfied with their current therapy - with a grade II or III according to the Kellgren and Lawrence radiological classification(1) on a posterio-anterior weight-bearing X-ray image of both knees performed at screening visit
*having given their written consent to take part in the study
*covered by social security or a health insurance policy (if required by local requirements). |
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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 or isolated lateral femorotibial OA of the knee - Paget's disease of bone, chondromatosis or villonodular synovitis - symptomatic hip OA - inflammatory, infectious or metabolic arthritis (rheumatoid arthritis, ankylosing spondylitis, abarticular rheumatism…) - hemochromatosis, ochronosis or hemophilia - history of disease (except OA) which the investigator considers likely to interfere with the assessment of the functional disability - Anticipated surgery of the knee during the course of the study
* Previous or concomitant treatment-related criteria: - patient having taken a symptomatic slow-acting drug for OA (SYSADOA) or a dietary supplement containing glucosamine, chondroitin sulphate, diacerhein or avocado-soybeans extracts in the 3 months preceding inclusion - patient having taken bisphosphonates or strontium ranelate in the 3 months preceding inclusion - patient having received any systemic 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 (except aspirin up to 325 mg/day for cardiovascular prophylactic) in the 2 days preceding inclusion (including topical application surrounding the target knee) or paracetamol in the 24 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 with a known allergy to the study medication or one of its constituents - patient requiring regular or intermittent steroid therapy.
* Patient-related criteria: - Body mass index (BMI) greater than or equal to 35 - 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 laboratory test results out of acceptable ranges and considered as clinically significant by the investigator performed at screening - 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: o pregnant, breast feeding or likely to become pregnant during the time of the study o women with childbearing potential not using effective contraception (oral contraceptive formulations, intrauterine device, tubal ligation or other efficient procedures)
* Rescue medication-related criteria: - patient with hypersensitivity to paracetamol.
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison at month 6 between the L0023 GE and Reference groups of the percentage of pain responders (patients with reduction of Womac pain score from baseline of ≥ 30 %), and additionally of function responders (patients with reduction of Womac function score from baseline of ≥ 20 %), |
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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 | 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) | No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
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
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last visit of the last patient |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |