Staining efficacy and safety of Methylene Blue enemas in patients undergoing flexible rectosigmoidoscopy - Methylene Blue enema staining in patients

Cosmo Technologies Ltd.0 个研究点开始时间: 2013年2月18日最近更新: 2015年1月6日

适应症

试验速览

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•1.Age: =18 year old;
•2.Rectosigmoidoscopy: out-patients with indication for rectosigmoidoscopy;
•3.Contraception (both males and females): either sterile subjects or subjects practising at least one reliable method of contraception or females in post-menopausal status for at least 1 year;
•4.Informed Consent: signed written informed consent prior to inclusion in the study.
•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 30
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
•2.Allergy: known or suspected hypersensitivity to the active principle; history of anaphylaxis to drugs or allergic reactions in general;
•3.Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, methaemoglobinemia, any other relevant disease that might interfere with the aim of the study;
•4.Comprehension: inability to comprehend the full nature and purpose of the study and unwillingness to co-operate with the investigator and to comply with the requirements of the entire study.

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