Clinical trial NCT01694966: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: CosmoTech
Sponsor class: UNKNOWN
First posted: 2012-09-27
Enrollment: 1249
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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.

Primary outcomes:
measure: 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.
timeFrame: +7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Dr Michelle Young
state: Arizona
city: Scottsdale
country: United States
facility: Dr Francesco Ramirez
state: Arizona
city: Lafayette
country: United States
facility: Dr David Gatof
state: Colorado
city: Jacksonville
country: United States
facility: Dr Michael Wallace
state: Florida
city: Kansas City
country: United States
facility: Dr Prateek Sharma
state: Kansas
city: Baltimore
country: United States
facility: Dr Marcia Canto
state: Maryland
city: Rochester
country: United States
facility: Dr David Bruining
state: Minnesota
city: Leuven
country: Belgium
facility: Dr Raf Bisschop
city: Toronto
country: Canada
facility: Dr Norman Marcon
state: Ontario
city: Wiesbaden
country: Germany
facility: Dr Ralf Kiesslich
city: Aviano
country: Italy
facility: Dr Renato Cannizzaro
city: Rome
country: Italy
facility: Dr Cesare Hassan
city: Rozzano
country: Italy
facility: Dr Alessandro Repici
city: Kaunas
country: Lithuania
facility: Dr Limas Kupcinskas
city: Amsterdam
country: Netherlands
facility: Dr Evelien Dekker
city: Rotterdam
country: Netherlands
facility: Dr Manoon Spander
city: Utrecht
country: Netherlands
facility: Dr Peter Siersema
city: Oxford
country: United Kingdom
facility: Dr James East
city: Stockton-on-Tees
country: United Kingdom
facility: Dr Matthew Rutter
Study officials:
affiliation: Co-ordinating Investigator EU
name: Alessandro Repici, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Co-ordinating Investigator US
name: Michael Wallace, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.