Patient présentant une ostéorthrose douloureuse d'au moins un des genoux. MedDRA version: 12.0 Level: LLT Classification code 10031165 Term: Osteoarthritis knee
Conditions
Interventions
Product Name: Diclofenac 1%, gel (Substipharm Développement)
Product Code: NA
Pharmaceutical Form: Gel
INN or Proposed INN: Diclofenac diethylamine
CAS Number: 78213-16-8
Current Sponsor code: NA
Othe
Sponsors
SUBSTIPHARM DEVELOPPEMENT
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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. | — |
Countries
France
Outcome results
None listed