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OpenTrials
Completed

NCT Number: NCT01694966

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr Raf Bisschop, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Methylene Blue MMX®

Drug

Other names: Investigational Product: Methylene Blue MMX® modified release tablets, Active Ingredient: Methylene Blue

Placebo

Drug

Sugar pill manufactured to mimic Methylene Blue MMX® tablet.

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.

    Time frame: +7 days

    Adenoma Detection Rate

Sponsors and collaborators

Lead sponsor

Cosmo Technologies Ltd

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 27, 2012
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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