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

Cosmo Technologies

Status and phase: Completed; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: Placebo; Drug: Methylene Blue MMX®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01694966

CB-17-01/06

2012-003983-32 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 1,249 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,249 participants in 3 patient groups, including a placebo group

Methylene Blue MMX® 200mg

Active Comparator group

Description:

Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule

Treatment:

Drug: Methylene Blue MMX®

Methylene Blue MMX® 100mg

Active Comparator group

Description:

Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule

Treatment:

Drug: Methylene Blue MMX®

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Oral dose, 8 Placebo tablets over a 4hr schedule

Treatment:

Drug: Placebo