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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT01694966
First received: September 25, 2012
Last updated: January 31, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Colorectal Cancer Drug: Methylene Blue MMX® Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy

Resource links provided by NLM:


Further study details as provided by Cosmo Technologies Ltd:

Primary Outcome Measures:
  • 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. [ Time Frame: +7 days ]

Enrollment: 1249
Study Start Date: September 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694966

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

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01694966     History of Changes
Other Study ID Numbers: CB-17-01/06
2012-003983-32 ( EudraCT Number )
Study First Received: September 25, 2012
Last Updated: January 31, 2017

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017