Colon Staining Efficacy of Single Oral Doses of Methylene Blue MMX

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 114 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Sex: males and females;. Age:18 to 70 years;. Colonoscopy: out-patients with indication for colonoscopy including faecal occult blood test positive colorectal cancer screening, polypectomy follow-up and inflammatory bowel disease check;. Contraception: either sterile subjects or subjects practising at least one reliable methods of contraception or in post-menopausal status for at least 1 year;. Informed Consent: signed written informed consent prior to inclusion in the study.

The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: pregnancy: pregnant or lactating women or at a risk of becoming pregnant;; allergy: known or suspected hypersensitivity to the active principle and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general;.

How the Study Was Run

It was run as a non-randomized, parallel-group and open-label study.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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.

It started in 2011-05-02 with completion listed for 2012-01-16.

Its stated primary purpose is diagnostic.

What Was Measured

It also tracked 6 secondary outcomes, for example Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Blood Pressure), Safety and Tolerability of Methylene Blue MMX as Determined by AEs, Safety and Tolerability of Methylene Blue MMX as Determined by Heart Rate, Safety and Tolerability of Methylene Blue MMX as Determined by Vital Signs (Oxygen Saturation in Peripheral Blood), Safety and Tolerability of Methylene Blue MMX as Determined Body Weight and Bowel Cleansing Quality-Boston Bowel Preparation Score.

What This Means in Plain Language

Put simply, this is a phase 2, non-randomized trial of Methylene blue (non-peptide stack partner) in 114 people.

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.