Status:
COMPLETED
Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX
Lead Sponsor:
Cosmo Technologies Ltd
Collaborating Sponsors:
Cross S.A.
Conditions:
Colon Staining in Preparation for Colonoscopy
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons.
Detailed Description
Objectives: To describe and evaluate the mucosal staining efficacy of Methylene Blue MMX® tablets after total oral doses of 150 or 200 mg in patients undergoing a full colonoscopy for various reasons...
Eligibility Criteria
Inclusion
- Sex: males and females;
- Age:18 to 70 years;
- Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;
- Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;
- Informed Consent: signed written informed consent prior to inclusion in the study.
Exclusion
- Pregnancy: pregnant or lactating women or at a risk of becoming pregnant;
- Allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;
- Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, inflammatory bowel diseases in active phase, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, any other relevant disease that might interfere with the aim of the study.
- 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.
Key Trial Info
Start Date :
May 2 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 16 2012
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT03287219
Start Date
May 2 2011
End Date
January 16 2012
Last Update
January 28 2021
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