The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Screening
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.
Alessandro Repici, MD
United States: Food and Drug Administration