Efficacy Study of Methenamine + Methylthioninium Chloride vs Phenazopyridine for the Symptomatic Control of Dysuria

What Was Tested

In this phase 3 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): Methenamine, Methylthioninium (experimental) and Phenazopyridine (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 316 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patients who agree to participate by agreeing to the terms proposed in the Clinical trial;. Patients aged over 18 years of any ethnicity;. Presence of dysuria with marking greater than or equal to 5 measured points on the categorical scale pre-treatment for pain symptom;.

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: patients who are febrile (axillary t º: ≥ 38 ° c), with back pain or lumbar;; patients with complicated clinical presentation of urinary tract infection;; patients with a history of allergy or intolerance to any known or suspected one of the ingredients of the product under investigation;.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

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

In this single-blind Methylene blue (non-peptide stack partner) study one party knew the assignments and the other did not.

Those kept unaware of assignments: investigator.

It started in 2016-06-27 with completion listed for 2016-11-21.

It ran at 4 sites in Brazil (4).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Safety of the study medication.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Methylene blue (non-peptide stack partner) in 316 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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