Patients undergoing a screening or surveillance colonoscopy to detect colonic lesions MedDRA version: 20.0 Level: LLT Classification code 10042759 Term: Symptoms involving digestive system System Organ Class: 100000004856
Conditions
Interventions
Product Name: Compresse a rilascio modificato di blu di metilene MMX® da 25 mg
Product Code: CB-17-01
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: BLU DI METILENE
CAS Number: 61-7
Sponsors
COSMO TECHNOLOGIES LTD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: men and women, = 50 years old inclusive 3. Indication: outpatients scheduled for screening or surveillance colonoscopy 4. Contraception: women of childbearing potential must use at least one reliable method of contraception or be abstinent. Women of non-childbearing potential or in post-menopausal status must have been in that status for at least 1 year. For all women of childbearing potential, serum pregnancy test result must be negative at screening. 5. 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. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Pregnancy: pregnant or lactating women or women undergoing fertility treatment or women at risk of becoming pregnant or women with a positive pregnancy test, if applicable. 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 laboratory testing. 4. Allergy: ascertained or presumptive hypersensitivity to methylene blue and/or ingredients of Methylene Blue MMX® tablets or PEG-based bowel cleansing preparations; 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 known colonic resection, severe known 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 patient. 6. Medications: previous or concomitant treatment with any serotonergic psychiatric medications within 2 weeks before the study, in accordance with a drug safety alert published by FDA. In particular, previous or concomitant treatment with the selective serotonin reuptake inhibitors (paroxetine, fluvoxamine, sertraline, citalopram, escitalopram, vilazodone etc.), the serotonin-norepinephrine reuptake inhibitors (venlafaxine, devenlafaxine, duloxetine), tricyclic antidepressants (amitriptyline, desipramine, clomipramine, imipramine, nortriptyline, protriptyline, doxepin, trimipramine), monoamine oxidase inhibitors (isocarboxazid, phenelzine, transdermal selegiline, tranylcypromine, etc.) 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: To evaluate the colonic lesion staining and flagging efficacy of single 200 mg oral doses of Methylene Blue MMX® 25 mg tablets administered to patients undergoing colonoscopy, in association with a high volume split dose regimen of bowel preparation, or a low volume split dose regimen of bowel preparation. Bowel cleansing quality will also be evaluated according to the validated Boston Bowel Preparation Scale (BBPS) after the intake of the bowel cleansing preparation and of a total dose of 200 mg of Methylene Blue MMX® 25 mg tablets administered the day before the colonoscopy procedure, with bowel preparation or water indicated volumes.;Secondary Objective: Polyp detection rate will be assessed. Safety and tolerability of oral Methylene Blue MMX® 25 mg tablets in association with different bowel preparations administered according to different schedules will be evaluated ;Primary end point(s): - To evaluate the colonic lesion staining and flagging efficacy of Methylene Blue MMX® 25 mg tablets after a total oral dose of 200 mg in association with a high volume split dose regimen or a low volume split dose regimen of bowel cleansing preparation or water. - To evaluate the Bowel cleansing quality according to the validated Boston Bowel Preparation Scale (BBPS) after the intake of the high volume split dose regimen or the low volume split dose regimen bowel cleansing preparation and of a total dose of 200 mg of Methylene Blue MMX® 25 mg tablets administered during the intake of the bowel cleansing preparation or water.;Timepoint(s) of evaluation of this end point: During the colonoscopy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the safety and tolerability of oral Methylene Blue MMX® 25 mg tablets in association with different bowel preparations administered according to different schedules. - To collect an endoscopic evaluation of the polyps detected after colonic mucosal staining obtained with a total dose of 200 mg of Methylene Blue MMX® 25 mg tablets, regardless of their removal: both removed polyps and polyps left in situ will be accounted for.;Timepoint(s) of evaluation of this end point: Visits 1 and 2. Early termination visit if applicable | — |
Countries
Italy
Contacts
Public ContactDiego Scanniffio
CROSS Research SA
Outcome results
None listed