Evaluation of therapeutic equivalence of diclofenac gel 1% formulation compared to Voltaren emulGel 1% gel in subjects with traumatic pathology: a double blind, randomized, phase III multicentre study. - ND

EPIFARMA S.R.L.0 个研究点开始时间: 2010年7月21日最近更新: 2012年3月19日

试验速览

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•1. Subjects willing and able to understand and sign an approved informed consent form; 2. Provision of written informed consent; 3. Subjects of either gender and aged 18-65 years: 4. Subjects with traumatic disease of the joints, muscles, tendons and ligaments; 5. If female and of child-bearing potential, the patient must be non-nursing and practicing an effective method of contraception throughout the study duration. All females of child-bearing potential must have a negative serum or urine pregnancy test prior the first administration.
•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) no
•F.1.3.1 Number of subjects for this age range

•1. Subjects unwilling to give an approved informed consent form; 2. Subjects with known osteo-musculo-articular lesions; 3. Female of child-bearing potential and lactating; 4. Presence of dermatological diseases in the area of application; 5. Treatment with any NSAID or drug containing diclofenac; 6. History of alcohol or drug abuse; 7. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation; 8. Subjects who, for whatever reason are unlikely to comply with study requirements; 9. Subjects who have received any investigational drug and/or non-approved drug within 12 weeks before the study entry; 10. Subjects who were previously enrolled in this study; 11. Employees of the centre (i.e. principal investigator, co-investigator, study coordinator, other staff member, and employees) with direct involvement in the study or other studies conducted or directed by the investigator in the centre, as well as relatives of employees or of the investigator.

发起方

EPIFARMA S.R.L.