search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Methylene Blue MMX®
Placebo
Sponsored by
Cosmo Technologies Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Dr Michelle Young
  • Dr Francesco Ramirez
  • Dr David Gatof
  • Dr Michael Wallace
  • Dr Prateek Sharma
  • Dr Marcia Canto
  • Dr David Bruining
  • Dr Raf Bisschop
  • Dr Norman Marcon
  • Dr Ralf Kiesslich
  • Dr Renato Cannizzaro
  • Dr Cesare Hassan
  • Dr Alessandro Repici
  • Dr Limas Kupcinskas
  • Dr Evelien Dekker
  • Dr Manoon Spander
  • Dr Peter Siersema
  • Dr James East
  • Dr Matthew Rutter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Methylene Blue MMX® 200mg

Methylene Blue MMX® 100mg

Placebo

Arm Description

Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule

Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule

Oral dose, 8 Placebo tablets over a 4hr schedule

Outcomes

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.
Adenoma Detection Rate

Secondary Outcome Measures

Full Information

First Posted
September 25, 2012
Last Updated
October 3, 2017
Sponsor
Cosmo Technologies Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT01694966
Brief Title
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Official Title
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cosmo Technologies Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylene Blue MMX® 200mg
Arm Type
Active Comparator
Arm Description
Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule
Arm Title
Methylene Blue MMX® 100mg
Arm Type
Active Comparator
Arm Description
Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral dose, 8 Placebo tablets over a 4hr schedule
Intervention Type
Drug
Intervention Name(s)
Methylene Blue MMX®
Other Intervention Name(s)
Investigational Product: Methylene Blue MMX® modified release tablets, Active Ingredient: Methylene Blue
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Primary Outcome Measure Information:
Title
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.
Description
Adenoma Detection Rate
Time Frame
+7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Repici, MD
Organizational Affiliation
Co-ordinating Investigator EU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Wallace, MD
Organizational Affiliation
Co-ordinating Investigator US
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr Michelle Young
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Dr Francesco Ramirez
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Dr David Gatof
City
Lafayette
State/Province
Colorado
ZIP/Postal Code
80026
Country
United States
Facility Name
Dr Michael Wallace
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Dr Prateek Sharma
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Facility Name
Dr Marcia Canto
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Dr David Bruining
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Dr Raf Bisschop
City
Leuven
Country
Belgium
Facility Name
Dr Norman Marcon
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Dr Ralf Kiesslich
City
Wiesbaden
Country
Germany
Facility Name
Dr Renato Cannizzaro
City
Aviano
Country
Italy
Facility Name
Dr Cesare Hassan
City
Rome
Country
Italy
Facility Name
Dr Alessandro Repici
City
Rozzano
Country
Italy
Facility Name
Dr Limas Kupcinskas
City
Kaunas
Country
Lithuania
Facility Name
Dr Evelien Dekker
City
Amsterdam
Country
Netherlands
Facility Name
Dr Manoon Spander
City
Rotterdam
Country
Netherlands
Facility Name
Dr Peter Siersema
City
Utrecht
Country
Netherlands
Facility Name
Dr James East
City
Oxford
Country
United Kingdom
Facility Name
Dr Matthew Rutter
City
Stockton-on-Tees
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
30742834
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs