The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
NCT ID: NCT01694966
Last Updated: 2017-11-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1249 participants
INTERVENTIONAL
2013-09-30
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
DOUBLE
Study Groups
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Methylene Blue MMX® 200mg
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Methylene Blue MMX®
Methylene Blue MMX® 100mg
Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Methylene Blue MMX®
Placebo
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Placebo
Oral dose, 8 Placebo tablets over a 4hr schedule
Placebo
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Interventions
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Methylene Blue MMX®
Placebo
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
75 Years
ALL
Yes
Sponsors
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Cosmo Technologies Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Alessandro Repici, MD
Role: PRINCIPAL_INVESTIGATOR
Co-ordinating Investigator EU
Michael Wallace, MD
Role: PRINCIPAL_INVESTIGATOR
Co-ordinating Investigator US
Locations
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Dr Michelle Young
Phoenix, Arizona, United States
Dr Francesco Ramirez
Scottsdale, Arizona, United States
Dr David Gatof
Lafayette, Colorado, United States
Dr Michael Wallace
Jacksonville, Florida, United States
Dr Prateek Sharma
Kansas City, Kansas, United States
Dr Marcia Canto
Baltimore, Maryland, United States
Dr David Bruining
Rochester, Minnesota, United States
Dr Raf Bisschop
Leuven, , Belgium
Dr Norman Marcon
Toronto, Ontario, 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
Countries
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References
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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.
Other Identifiers
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2012-003983-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CB-17-01/06
Identifier Type: -
Identifier Source: org_study_id