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Trial record 1 of 1 for:    the safety and efficacy of methylene blue mmx modified release tablets administered to subjects undergoing screening or surveillance
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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 is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Cosmo Technologies Ltd
Sponsor:
Information provided by (Responsible Party):
Cosmo Technologies Ltd
ClinicalTrials.gov Identifier:
NCT01694966
First received: September 25, 2012
Last updated: November 17, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1270
Study Start Date: September 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (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
Genders Eligible for Study:   Both
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

Contacts
Contact: Rose Wyer +35318170384 rwyer@cosmopharma.com

Locations
United States, Arizona
Dr Francesco Ramirez Not yet recruiting
Scottsdale, Arizona, United States, 85259
United States, Florida
Dr Michael Wallace Not yet recruiting
Jacksonville, Florida, United States, 32224
United States, Kansas
Dr Prateek Sharma Not yet recruiting
Kansas City, Kansas, United States, 66103
United States, Maryland
Dr Marcia Canto Not yet recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Dr Ram Chuttani Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Minnesota
Dr David Bruining Not yet recruiting
Rochester, Minnesota, United States, 55905
Belgium
Dr Raf Bisschop Not yet recruiting
Leuven, Belgium
Canada, Ontario
Dr Norman Marcon Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Germany
Dr Ralph Kiesslich Not yet recruiting
Frankfurt, Germany
Italy
Dr Alessandro Repici Recruiting
Rozzano, Italy
Netherlands
Dr Evelien Dekker Not yet recruiting
Amsterdam, Netherlands
Dr Manoon Spander Not yet recruiting
Rotterdam, Netherlands
Dr Peter Siersema Not yet recruiting
Utrecht, Netherlands
United Kingdom
Dr James East Not yet recruiting
Oxford, United Kingdom
Sponsors and Collaborators
Cosmo Technologies Ltd
Investigators
Principal Investigator: Alessandro Repici, MD Co-ordinating Investigator
Principal Investigator: Michael Wallace, MD Co-ordinating Investigator
  More Information

No publications provided

Responsible Party: Cosmo Technologies Ltd
ClinicalTrials.gov Identifier: NCT01694966     History of Changes
Other Study ID Numbers: CB-17-01/06, 2012-003983-32
Study First Received: September 25, 2012
Last Updated: November 17, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 25, 2014