The safety and effectiveness of Methylene Blue MMX® tablets given to patients undergoing screening or surveillance colonoscopy.

Phase 1

• Conditions: Polyp and adenoma detection during colonoscopy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

• Registration Number: EUCTR2012-003983-32-LT
• Lead Sponsor: Cosmo Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-03
• Last Update Posted: 9 January 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1270

Inclusion Criteria

• Males or females, aged between 50 and 75.
• 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

• Patients at high risk of colorectal cancer e.g. ulcerative colitis
• 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 evidence of glucose-6-phosphate deficiency,
• Known 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.

Study & Design

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