The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
2 other identifiers
interventional
1,249
8 countries
19
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Sep 2013
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
November 6, 2017
CompletedNovember 6, 2017
October 1, 2017
3.1 years
September 25, 2012
August 25, 2017
October 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (3)
Methylene Blue MMX® 200mg
ACTIVE COMPARATOROral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX® 100mg
ACTIVE COMPARATOROral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Placebo
PLACEBO COMPARATOROral dose, 8 Placebo tablets over a 4hr schedule
Interventions
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Dr Michelle Young
Phoenix, Arizona, 85012, United States
Dr Francesco Ramirez
Scottsdale, Arizona, 85259, United States
Dr David Gatof
Lafayette, Colorado, 80026, United States
Dr Michael Wallace
Jacksonville, Florida, 32224, United States
Dr Prateek Sharma
Kansas City, Kansas, 66103, United States
Dr Marcia Canto
Baltimore, Maryland, 21287, United States
Dr David Bruining
Rochester, Minnesota, 55905, United States
Dr Raf Bisschop
Leuven, Belgium
Dr Norman Marcon
Toronto, Ontario, M5B 1W8, Canada
Dr Ralf Kiesslich
Wiesbaden, Germany
Dr Renato Cannizzaro
Aviano, Italy
Dr Cesare Hassan
Rome, Italy
Dr Alessandro Repici
Rozzano, Italy
Dr Limas Kupcinskas
Kaunas, Lithuania
Dr Evelien Dekker
Amsterdam, Netherlands
Dr Manoon Spander
Rotterdam, Netherlands
Dr Peter Siersema
Utrecht, Netherlands
Dr James East
Oxford, United Kingdom
Dr Matthew Rutter
Stockton-on-Tees, United Kingdom
Related Publications (1)
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.
PMID: 30742834DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- R&D Manager
- Organization
- Cosmo Technologies Ltd
Study Officials
- PRINCIPAL INVESTIGATOR
Alessandro Repici, MD
Co-ordinating Investigator EU
- PRINCIPAL INVESTIGATOR
Michael Wallace, MD
Co-ordinating Investigator US
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2012
First Posted
September 27, 2012
Study Start
September 1, 2013
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
November 6, 2017
Results First Posted
November 6, 2017
Record last verified: 2017-10