At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,249 enrolled
Drug / intervention
Methylene Blue MMX® +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
In Brief
A Phase 3 clinical trial evaluating Methylene Blue MMX® and Placebo for Colorectal Cancer. Completed, enrolled 1,249 participants across 19 sites in 8 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColorectal Cancer
CountriesBelgium, Canada, Germany, Italy, Lithuania, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartSep 2013
Primary CompletionOct 2016
TodayJul 2026
First PostedSep 27, 2012
Enrollment StartSep 1, 2013
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 13.8 years ago
Interventions
Methylene Blue MMX®drug
Placebodrug
Sugar pill manufactured to mimic Methylene Blue MMX® tablet.