The safety and efficacy of Methylene Blue MMX® modified release tablets administered to subjects undergoing screening or surveillance colonoscopy.

Phase 3

Completed

• Conditions: Polyp and adenoma detection during colonoscopy. Abnormal growth of tissue detection during colonoscopy; 10017987

• Registration Number: NL-OMON41630
• Lead Sponsor: Cosmo Technologies Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 272

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.
* Patients taking psychiatric medications which could possibly interact with methylene blue are not to be included in the study if they have been taken up to 2 weeks prior to enrolment. Prozac is prohibited up to 5 weeks prior to enrolment.
* Patients will be included in accordance with the opinion of the countrywide screening committee.

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.
* Men and women, between 50-75 years of age, who have accepted invitation to enrol in the national bowel cancer screening programme.

Study & Design

• Study Type: Interventional
• Study Design: Not specified