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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Methylene Blue MMX®; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1249
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium
    • Dr Raf Bisschop
• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Dr Norman Marcon
• Germany
  • Wiesbaden, Germany
    • Dr Ralf Kiesslich
• Italy
  • Aviano, Italy
    • Dr Renato Cannizzaro
  • Rome, Italy
    • Dr Cesare Hassan
  • Rozzano, Italy
    • Dr Alessandro Repici
• Lithuania
  • Kaunas, Lithuania
    • Dr Limas Kupcinskas
• Netherlands
  • Amsterdam, Netherlands
    • Dr Evelien Dekker
  • Rotterdam, Netherlands
    • Dr Manoon Spander
  • Utrecht, Netherlands
    • Dr Peter Siersema
• United Kingdom
  • Oxford, United Kingdom
    • Dr James East
  • Stockton-on-Tees, United Kingdom
    • Dr Matthew Rutter
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Dr Michelle Young
    • Scottsdale, Arizona, United States, 85259
      • Dr Francesco Ramirez
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • Dr David Gatof
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Dr Michael Wallace
  • Kansas
    • Kansas City, Kansas, United States, 66103
      • Dr Prateek Sharma
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Dr Marcia Canto
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Dr David Bruining

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Methylene Blue MMX® 200mg; Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule	Drug: Methylene Blue MMX®; Other Names: Investigational Product: Methylene Blue MMX® modified release tablets; Active Ingredient: Methylene Blue
Active Comparator: Methylene Blue MMX® 100mg; Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule	Drug: Methylene Blue MMX®; Other Names: Investigational Product: Methylene Blue MMX® modified release tablets; Active Ingredient: Methylene Blue; Drug: Placebo; Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Placebo Comparator: Placebo; Oral dose, 8 Placebo tablets over a 4hr schedule	Drug: Placebo; Sugar pill manufactured to mimic Methylene Blue MMX® tablet.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cosmo Technologies Ltd
• Investigators: Principal Investigator: Alessandro Repici, MD, Co-ordinating Investigator EU; Principal Investigator: Michael Wallace, MD, Co-ordinating Investigator US

Publications and helpful links

General Publications

• Repici A, Wallace MB, East JE, Sharma P, Ramirez FC, Bruining DH, Young M, Gatof D, Irene Mimi Canto M, Marcon N, Cannizzaro R, Kiesslich R, Rutter M, Dekker E, Siersema PD, Spaander M, Kupcinskas L, Jonaitis L, Bisschops R, Radaelli F, Bhandari P, Wilson A, Early D, Gupta N, Vieth M, Lauwers GY, Rossini M, Hassan C. Efficacy of Per-oral Methylene Blue Formulation for Screening Colonoscopy. Gastroenterology. 2019 Jun;156(8):2198-2207.e1. doi: 10.1053/j.gastro.2019.02.001. Epub 2019 Feb 10.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: September 25, 2012
• First Submitted That Met QC Criteria: September 25, 2012
• First Posted (Estimate): September 27, 2012

Study Record Updates

• Last Update Posted (Actual): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Methylene Blue
• Other Study ID Numbers: CB-17-01/06; 2012-003983-32 (EudraCT Number)