A multicenter, randomized, patient-blind, investigator-blind, placebo-controlled, crossover study of Lidocaine + Prilocaine/Verisfield (2.5+2.5)% w/w cream and EMLA/AstraZeneca cream, in patients undergoing haemodialysis

Verisfield (UK) Ltd0 个研究点开始时间: 2013年1月14日最近更新: 2013年8月5日

适应症

试验速览

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•Subjects fulfilling all of the following criteria may be included in the study:
•1.Availability of the subject for the entire duration of the study period;
•2.Ability to comprehend and be informed of the nature of the study;
•3.Read and sign the informed consent form (ICF) as well as willingness to adhere to the protocol requirements;
•4.Males and females of at least 18 years of age, undergoing chronic haemodialysis;
•5.Ability to understand and use the Visual Analogue Scale to rate his/her pain.
•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 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

•Subjects who meet any of the following criteria will be excluded from the study:
•1.Known allergies or sensitivities to lidocaine, prilocaine, or other local anaesthetic;
•2.Congenital or idiopathic form of methaemoglobinemia;
•3.Participation in any other clinical trial involving investigational products within 30 days prior to enrolment or intention to participate in another clinical trial involving investigational products during participation in this study;
•4.Damaged, denuded, or broken skin at the designated site;
•5.Concomitant use of an analgesic within the previous 24 hours;
•6.Previous use of lidocaine/prilocaine cream;
•7.Female subjects who are pregnant or breast-feeding;
•8.Any other condition or situation that in the opinion of the study physician would make the subject unsuitable for enrolment or could interfere with the subject participating in and completing the study, such as known psychiatric, visual or neurologic disorders which can influence the assessment of pain.

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