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

Phase 3

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Placebo; Drug: Methylene Blue MMX®

• Registration Number: NCT01694966
• Lead Sponsor: Cosmo Technologies Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-25
• Study First Posted: 2012-09-27
• Study Start: 2013-09
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-08-25
• Status Verified: 2017-10
• Results First Submitted QC: 2017-10-03
• Last Update Submitted: 2017-10-03
• Results First Posted: 2017-11-06
• Last Update Posted: 2017-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1249

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral dose, 8 Placebo tablets over a 4hr schedule
Methylene Blue MMX® 100mg	Methylene Blue MMX®	Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Methylene Blue MMX® 100mg	Placebo	Oral dose, 4 Methylene Blue MMX® tablets and 4 Placebo tablets over a 4hr schedule
Methylene Blue MMX® 200mg	Methylene Blue MMX®	Oral dose, 8 Methylene Blue MMX® tablets over a 4hr schedule

Primary Outcome Measures

Name	Time	Method
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.	+7 days	Adenoma Detection Rate

Trial Locations

Locations (19)

Dr David Gatof; 🇺🇸 Lafayette, Colorado, United States

Dr Michael Wallace; 🇺🇸 Jacksonville, Florida, United States

Dr Ralf Kiesslich; 🇩🇪 Wiesbaden, Germany

Dr James East; 🇬🇧 Oxford, United Kingdom

Dr Matthew Rutter; 🇬🇧 Stockton-on-Tees, United Kingdom

Dr Michelle Young; 🇺🇸 Phoenix, Arizona, United States

Dr Francesco Ramirez; 🇺🇸 Scottsdale, Arizona, United States

Dr Marcia Canto; 🇺🇸 Baltimore, Maryland, United States

Dr Norman Marcon; 🇨🇦 Toronto, Ontario, Canada

Dr Raf Bisschop; 🇧🇪 Leuven, Belgium

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 Prateek Sharma; 🇺🇸 Kansas City, Kansas, United States

Dr David Bruining; 🇺🇸 Rochester, Minnesota, United States

Dr Renato Cannizzaro; 🇮🇹 Aviano, Italy