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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01694966
• Other study ID #: CB-17-01/06
• Secondary ID: 2012-003983-32
• Status: Completed
• Phase: Phase 3
• First received: September 25, 2012
• Last updated: October 3, 2017
• Start date: September 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2017
• Source: Cosmo Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1249
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Methylene Blue MMX®

• Placebo
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.

Locations

Country	Name	City	State
Belgium	Dr Raf Bisschop	Leuven
Canada	Dr Norman Marcon	Toronto	Ontario
Germany	Dr Ralf Kiesslich	Wiesbaden
Italy	Dr Renato Cannizzaro	Aviano
Italy	Dr Cesare Hassan	Rome
Italy	Dr Alessandro Repici	Rozzano
Lithuania	Dr Limas Kupcinskas	Kaunas
Netherlands	Dr Evelien Dekker	Amsterdam
Netherlands	Dr Manoon Spander	Rotterdam
Netherlands	Dr Peter Siersema	Utrecht
United Kingdom	Dr James East	Oxford
United Kingdom	Dr Matthew Rutter	Stockton-on-Tees
United States	Dr Marcia Canto	Baltimore	Maryland
United States	Dr Michael Wallace	Jacksonville	Florida
United States	Dr Prateek Sharma	Kansas City	Kansas
United States	Dr David Gatof	Lafayette	Colorado
United States	Dr Michelle Young	Phoenix	Arizona
United States	Dr David Bruining	Rochester	Minnesota
United States	Dr Francesco Ramirez	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Cosmo Technologies Ltd

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Italy,  Lithuania,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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