Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

• Status: Completed
• Trial end date: 2012-01-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cosmo Technologies Ltd
• Collaborator: Cross S.A.
• Treatments: Methylene Blue

Criteria

Inclusion Criteria:

1. Sex: males and females;

2. Age:18 to 70 years;

3. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;

4. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;

5. Informed Consent: signed written informed consent prior to inclusion in the study.

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 and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;

3. 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.

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.