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

Completed · Phase 3 · Has a placebo group

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT01694966

Run by

Cosmo Technologies Ltd

People needed

1249

Starts

2013-09-01

Expected to finish

2016-10-01

Last updated by the study team

2017-11-06

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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