Polyp and adenoma detection during colonoscopy
Conditions
Interventions
Product Name: Methylene Blue MMX® modified release tablets
Product Code: CB-17-01
Pharmaceutical Form: Tablet
INN or Proposed INN: Methylthioninium Chloride
CAS Number: 61-73-4
Current Sponsor code: C
Sponsors
Cosmo Technologies Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Males or females, aged between 50 and 75. • A female is eligible to enter and participate in this study if she is: of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy or postmenopausal.Or of child bearing potential, has a negative serum pregnancy test at screening and urine pregnancy test prior to start the study drug, and abstain completely from sexual intercourse or agrees to using highly effective contraceptive methods (e.g. intrauterine device, hormonal contraceptive drug, tubal ligation) during the study until completion of the follow-up procedures). • Outpatients scheduled for screening or surveillance colonoscopy for polyps or colorectal cancer. • Able to comprehend the full nature and purpose of the study, including possible risks and side effects. • Able to co-operate with the investigator and to comply with the requirements of the entire study. • Signed written informed consent prior to 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 635 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 635
Exclusion criteria
Exclusion criteria: • Patients at high risk of colorectal cancer e.g. ulcerative colitis • Pregnancy or lactation. • Previous medical history of, or suspected hypersensitivity to, the Methylene Blue and/or formulations' ingredients. • Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients. • Previous medical history of gastrointestinal obstruction or perforation, toxic megacolon, major colonic resection, severe diverticulitis, heart failure (Class III or IV), serious cardiovascular disease, ulcerative colitis or Crohn’s disease. • ALT, AST, GGT, Bilirubin, Creatinine or Urea greater than 2.5 x the upper limit for normal range, based on local laboratory testing. • The presence of serious cardiovascular disease, including very large abdominal aortic aneurysms (particularly if they are symptomatic), patients who are immediately postoperative, and patients who have suffered recent myocardial infarction (within 3 weeks), pulmonary embolism, or are currently hemodynamically unstable. • The presence of liver disease with coagulopathy • A history of anaemia (previously recorded haemoglobin of less than 10mg/dL) within the last 30 days prior to enrollment. • Known or suspected deficiency of glucose-6-phosphate dehydrogenase, • Known or suspected deficiency of NADPH reductase • Treatment within 5 weeks prior to randomisation with Fluoxetine (Prozac). • Concurrent treatment, or previous treatment within 2 weeks with any of the prohibited psychiatric medications that may interact with Methylene Blue as listed under Prohibited medications; Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinepherine Reuptake Inhibitors (SNRI’s), listed Tricyclic anti-depressants or Monoamine oxidase A inhibitors. • Current enrollment in any other clinical trial, or previous enrollment in a clinical trial within the last 30 days. • Other medical condition that in the investigators opinion would make the administration of the study drug or procedures hazardous to the subject.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the histologically proven adenoma and carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast, obtained with placebo tablets is equivalent to a standard white light colonoscopy endoscopic procedure- the current standard of care. ;Secondary Objective: Not Applicable;Primary end point(s): The primary end-point of this study is to assess the detection efficacy of chromoendoscopy performed with 200mg Methylene Blue MMX® 25 mg tablets versus placebo tablets (white light endoscopy) in terms of the proportion of subjects with at least one histologically proven adenoma or carcinoma. Adenoma is defined as the histological Vienna Grade 3 to 4.2. Histologically proven carcinoma is defined as Vienna Grade 4.3 to 5b. The Vienna Classification will be made by blinded central laboratory pathologists who will review slides prepared from an additional tissue section of each paraffin embedded specimen prepared at the local site laboratory in accordance with the histology charter. ;Timepoint(s) of evaluation of this end point: Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints will be evaluated in all study groups, e.g. 200mg, 100mg MMX and placebo groups. Secondary end-points of this study are the following: > False positive rate between treatment and placebo control arms; the rate being defined as the proportion of patients with no histologically confirmed adenoma or carcinoma within any of the subjects excised lesions and the subject having undergone at least one excision (see protocol section 16.3) > Number of histologically proven adenomas (Vienna categories 3, 4.1 and 4.2) and carcinomas (Vienna categories 4.3, 4.4, 5.a and 5.b) detected per subject. > Number of histologically proven serrated lesions (traditional serrated adenomas, sessile serrated adenomas, hyperplastic polyps, fibroblastic polyps and mixed polyps) detected per subject; > Adverse events; > Vital signs during colonoscopy (Systolic blood pressure, Diastolic blood pressure, Heart rate and Oxygen saturation); > Renal and liver function tests (Creatinine, Urea, AST, GGT, ALT and Total Bilirubin;Timepoint(s) of evaluation of this end point: Day 45 | — |
Countries
Belgium, Canada, Germany, Italy, Lithuania, Netherlands, United Kingdom, United States
Contacts
Public ContactResearch & Development Manager
Cosmo Technologies Ltd
Outcome results
None listed