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

What Was Tested

This registered phase 3 trial tested Methylene blue (non-peptide stack partner).

It had three arms (groups): one (active comparator), one (active comparator) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 1249 actual participants took part.

It was open to people of any sex aged from 50 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2013-09 with completion listed for 2016-10.

It ran at 19 sites in United States (7), Italy (3), Netherlands (3), United Kingdom (2), Belgium (1) and Canada (1).

Its stated primary purpose is screening.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 1249 people.

With 1249 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.