Effect of Oral Administration of Methylene Blue MMX Tablets on Double Stranded DNA

What Was Tested

This registered phase 2 trial tested Methylene blue (non-peptide stack partner).

Single Centre, open label assignment phase II clinical study.

It had two arms (groups): Group A (placebo comparator) and Group B (active comparator).

Biopsy samples collected during standard white light colonoscopy.

Subjects who have had samples collected during a Group A colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their previous group A colonoscopy for histone gamma H2AX activity.

The registry classes the interventions as drug and procedure.

More on the Plan

Secondary Objectives : To evaluate the safety and tolerability of oral Methylene Blue MMX® tablets..

To evaluate the staining score for colonoscopy obtained with oral Methylene Blue MMX® tablets .

Time to reach the caecum during colonoscopy and withdrawal time from caecum to exit.

Who Took Part

Enrollment: 10 actual participants took part.

It was open to people of any sex aged from 18 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 18 and 75. Outpatients scheduled for screening or surveillance colonoscopy. Subjects must be identified as having the clinical requirement for second colonoscopy within 2weeks of the initial colonoscopy. Women of childbearing potential must use at least one reliable method of contraception, be surgically sterilised or be abstinent. For female subjects, a negative serum pregnancy test is required before Methylene Blue MMX® tablets are dispensed to the subject.

The full record lists 9 inclusion and 13 exclusion criteria; among the exclusions: no pregnant or lactating women, or women undergoing fertility treatment; no previous medical history of, or suspected hypersensitivity to the methylene blue and/or this formulations ingredients; no previous medical history of, or suspected hypersensitivity to the peg based bowel cleansing preparation and/or this formulations ingredients.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Everyone knew when Methylene blue (non-peptide stack partner) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-02 with completion listed for 2014-12.

It ran at 1 site in Italy.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): Gamma H2AX Histone Levels in Colonic Biopsy During Standard White Light Colonoscopy and Colonoscopy for Which Methylene Blue MMX Was Taken Prior to Initiating the Colonoscopy (time frame: 2 weeks).

It also tracked 1 secondary outcome, for example To Evaluate the Staining Quality Obtained With Oral Methylene Blue MMX® Tablets.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Methylene blue (non-peptide stack partner) in 10 people.

Its size is small, so on its own it can only give an early look.

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.