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

NCT01694966 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Cosmo Technologies Ltd
Phase	Phase 3
Status	COMPLETED
Enrolment	1249
Start date	2013-09
Completion	2016-10

Conditions

• Colorectal Cancer

Interventions

• Methylene Blue MMX®
• Placebo

Primary outcomes

• 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

Countries

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