E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patient présentant une ostéorthrose douloureuse d'au moins un des genoux. |
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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 | 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 |
Main objective: Demonstrate the equivalence of the clinical efficacy of the generic product Diclofenac 1% gel (Substipharm Développement) versus the reference Voltarol® Emulgel® 1% (Novartis) for the symptomatic treatment of the osteoarthritis of the knee and its superiority versus placebo. |
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E.2.2 | Secondary objectives of the trial |
Secondary objective: Compare the safety of the generic product Diclofenac 1% gel (Substipharm Développement) versus the reference product Voltarol® Emulgel® 1% (Novartis) and versus placebo. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must meet all the following criteria to be included in the study : Male or female patients aged 50 to 75 years; Capable of consent ; Having given their written informed consent; Willingness to adhere to the protocol requirement; With primary osteoarthritis of at least one knee with joint space narrowing or formation of osteophytes or subchondral cysts demonstrated on a radiological examination within the last 6 months; Having a WOMAC pain score of at least 3 points. |
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E.4 | Principal exclusion criteria |
Patients to whom any of the following applies will be not included in the study : Secondary osteoarthritis related to systemic inflammatory arthritis including rheumatoid arthritis, psoriasic arthritis, post-infectious arthritis and metabolic arthritis… Pregnant women, menopaused for less than 2 years or not under effective contraception or women breastfeeding women; Traumatic pain; Body mass index > 35; Ongoing use of NSAID, analgesic, muscle relaxant or within the previous 10 days; Ongoing use of glucosamine, chondroïtin sulphate, piascledine, diacerheine and food supplementation dedicated to joint problems or within the previous 8 weeks; Ongoing use of oral or topical corticosteroid within the previous 14 days or intramuscular corticosteroid within 30 days or intra-articular injection of corticosteroid within the previous 90 days; Allergy to other product whose activity is similar to those of diclofenac, as other NSAI and acetylsalicylic acid; Knee surgery within the previous 6 months; Severe disease and particularly an immunodeficiency or cancer; Allergy or contra-indication to the studied products or its excipients; Clinically active renal, hepatic or peptic ulcer disease; History of alcohol or drug abuse; Concomitant skin disease at the application site; Chronic inflammatory disease such as colitis and history of fibromyalgia; Poor motivation, mental deficiency or administrative and legal decision likely to limit the validity of consent to participate in the study or limit the patients’ ability to comply with the protocol requirement; Inability to understand and to observe the instructions of the physician. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Démontrer l’équivalence de l’efficacité clinique du topique générique ‘Diclofenac 1%, gel’ (diclofenac diethylamine : 1.16%) (SUBSTIPHARM DEVELOPPEMENT) versus le traitement de référence Voltarol® Emulgel® 1% (NOVARTIS) et sa supériorité versus placebo dans le traitement symptomatique de l’arthrose du genou. |
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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 | No |
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) | 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 | 108 |
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
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Last visit of the last subject |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |