drugset / Trial / NCT01694966

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

NCT01694966

Phase 3 Completed 1249 enrolled Cosmo Technologies Ltd
RandomizedParallel-groupDouble-blindScreening

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.

Timeline

Start
2013-09
Primary completion
2016-10
Completion
2016-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylene Blue Diagnostic / imaging agent 100 mg Oral
Comparator Methylene Blue Diagnostic / imaging agent 200 mg Oral

Indications