Staining efficacy and safety of Methylene Blue enemas in patients undergoing rectum and sigma examination for various reasons

• Conditions: Out-patients of both sexes with indication for diagnostic flexible rectosigmoidoscopy.; MedDRA version: 14.1Level: LLTClassification code 10016774Term: Flexible sigmoidoscopySystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2013-000452-18-IT
• Lead Sponsor: Cosmo Technologies Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-18
• Last Update Posted: 6 January 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified