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

Study Overview
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Brief Summary
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Methylene Blue MMX®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Methylene Blue MMX® 200mg<br>Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule | Drug: Methylene Blue MMX®<br> <br> * Other names: Active Ingredient: Methylene Blue;|
| Active Comparator: Methylene Blue MMX® 100mg<br>Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule | Drug: Methylene Blue MMX®<br> <br> * Other names: Active Ingredient: Methylene Blue;Drug: Placebo<br>* Sugar pill manufactured to mimic Methylene Blue MMX® tablet.<br>|
| Placebo Comparator: Placebo<br>Oral dose, 8 Placebo tablets over a 4hr schedule | Drug: Placebo<br>* Sugar pill manufactured to mimic Methylene Blue MMX® tablet.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Adenoma Detection Rate | +7 days |