The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cosmo Technologies Ltd
• Treatments: Methylene Blue

Criteria

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.

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.