Effect of oral administration of Methylene Blue MMX® tablets on DNA damage assessed by analysis of colon biopsy samples

• Conditions: Out-patients of both sexes scheduled for a screening or surveillance colonoscopy and identified as having the clinical requirement for a second colonoscopy within 2 weeks of the initial colonoscopy.; MedDRA version: 15.1Level: PTClassification code 10010007Term: ColonoscopySystem Organ Class: 10022891 - Investigations; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2013-000634-35-IT
• Lead Sponsor: Cosmo Technologies Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-20
• Last Update Posted: 19 October 2015

Recruitment & Eligibility

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

Inclusion Criteria

1. Age: 18-75 years old inclusive
2. Indication: outpatients scheduled for screening or surveillance colonoscopy identified as having the clinical requirement for a second colonoscopy within 2 weeks of the initial colonoscopy
3. Contraception: women of childbearing potential must use at least one reliable method of contraception or be abstinent. Women of non-child-bearing potential or in post-menopausal status must have been in that status for at least 1 year. For all women, pregnancy test result must be negative at screening
4. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study
5. Informed consent: signed written informed consent before 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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

1. Pregnancy: pregnant or lactating women or women undergoing fertility treatment
2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness; in particular, ALT, AST, ?-GT, bilirubin, creatinine or urea greater than 2.5 x the upper limit for normal, based on local laboratory testing
4. Allergy: ascertained or presumptive hypersensitivity to methylene blue and/or ingredients of both Methylene Blue MMX tablets and PEG-based bowel cleansing preparation; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study
5. Diseases: known or suspected gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulosis with diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, severe liver failure, end-stage renal insufficiency, clinical alarm symptoms or history of anaemia (previously recorded haemoglobin of less than 10mg/dL), frank blood in the stool within the last 30 days prior to enrolment, known deficiency of glucose-6-phosphate dehydrogenase, known deficiency of NADPH reductase, methaemoglobinemia and any other medical condition that in the investigator’s opinion would make the administration of the study drug or procedures hazardous to the subject
6. Medications: previous or concomitant treatment with any monoamine oxidase inhibitor in accordance with a drug safety alert published by FDA (40). In particular, previous or concomitant treatment with the selective serotonin reuptake inhibitors (paroxetine, fluvoxamine, sertraline, citalopram, etc.), the serotonin-norepinephrine reuptake inhibitors (venlafaxine, devenlafaxine, duloxetine), tricyclic antidepressants (amitriptyline, desipramine, clomipramine, imipramine, nortriptyline, protriptyline, doxepin, trimipramine) and other psychiatric drugs (amoxapine, maprotiline, nefazodone, trazodone, bupropion, buspirone, vilazodone, mirtazapine) within 2 weeks before the study, previous or concomitant treatment with fluoxetine within 5 weeks before the study and/or previous or concomitant treatment with anticoagulants or antiaggregants inducing an INR>1.5

Study & Design

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