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


Phase 3
50 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening

Outcome Measure:

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.

Outcome Time Frame:

+7 days

Safety Issue:

No

Principal Investigator

Alessandro Repici, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Co-ordinating Investigator

Authority:

United States: Food and Drug Administration

Study ID:

CB-17-01/06

NCT ID:

NCT01694966

Start Date:

September 2013

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms

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