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: 15.1 Level: PT Classification code 10010007 Term: Colonoscopy System Organ Class: 10022891 - Investigations
Conditions
Interventions
Product Name: Methylene blue MMX® 25 mg modified release tablets
Product Code: CB-17-01
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Methylthioninium chloride
Current Sponsor code
Sponsors
Cosmo Technologies Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the effect of a total oral dose of 200 mg of Methylene Blue MMX® tablets on colonic epithelial double-stranded DNA during a full chromoendoscopy in comparison with a standard white light colonoscopy without use of Methylene Blue MMX®.;Secondary Objective: 1. To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets. 2. To evaluate the staining quality obtained with oral Methylene Blue MMX® tablets. 3. To evaluate the colonoscopy duration with and without intake of Methylene Blue MMX® tablets. ;Primary end point(s): Evaluation, by histone ?H2AX analysis, of the effect of a total oral dose of 200 mg of Methylene Blue MMX® tablets on colonic epithelial double-stranded DNA in colonic biopsy samples collected during chromoendoscopy as compared to control biopsies collected during standard white light colonoscopy without Methylene Blue MMX®.;Timepoint(s) of evaluation of this end point: Samples for ?H2AX analysis will be collected from colonic regions of apparently normal appearance during the first and the second endoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. safety and tolerability of oral Methylene Blue MMX® tablets; 2. staining quality obtained with oral Methylene Blue MMX® tablets; 3. colonoscopy duration with and without intake of Methylene Blue MMX® tablets. ;Timepoint(s) of evaluation of this end point: Safety and tolerability of oral Methylene Blue MMX® tablets will be evaluated prior, during and after the second colonoscopy. Mucosal staining quality will be scored during the second colonoscopy, according to a subjective six-point scale scoring system. Colonoscopy duration will be evaluated during each endoscopy. | — |
Countries
Italy
Contacts
Public ContactStudy Management Unit
CROSS S.A.
Outcome results
None listed