MEthylene Blue In Patients With Acquired Methemoglobinemia

What Was Tested

This registered phase 4 trial tested Methylene blue (non-peptide stack partner).

This is an open label, uncontrolled, Phase 4 study including 10 patients who present in hospital/urgent care setting with acquired methemoglobinemia.

The population may include pediatric and adult patients (males and females of all ages are included).

The study will run in both the EU and the US.

It had 1 arm (groups): ProvayBlue (Methylene Blue) arm (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7 actual participants took part.

It was open to people of any sex.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Written informed consent obtained prior to any data collection (retrospective and prospective) for this study and study specific assessments.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: known severe hypersensitivity reactions to methylene blue or any other thiazine dye;; known deficiency in glucose-6-phosphate dehydrogenase (g6pd) due to the risk of hemolytic anemia as well as lack of therapeutic effect;.

How the Study Was Run

It was run as a single-group and open-label study.

Nothing was hidden in this open-label Methylene blue (non-peptide stack partner) study: the participants and staff both knew the treatment.

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

It started in 2018-07-06 with completion listed for 2020-08-31.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 7 secondary outcomes, for example Number of Participants With and Without Concomitant Normalization of Respiratory Rate, Number of Participants With and Without Concomitant Normalization of Heart Rate, Number of Participants With and Without Concomitant Normalization of Blood Pressure, Number of Participants With Treatment-related Adverse Events, Methylene Blue Content in Blood Samples and Azure B Content in Blood Samples.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Methylene blue (non-peptide stack partner) in 7 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.