drugset / Trial / NCT03379389

Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

NCT03379389

Phase 4 Completed 284 enrolled Fundação Educacional Serra dos Órgãos
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a double-blind, randomized, double-dummy, comparative study in parallel groups of subjects presenting with recurrent cystitis (≥2 episodes within the past 6 months). Subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for three days, followed by three days of antibiotic therapy as determined by urine culture and antibiogram. This study aims to assess the efficacy and safety of each treatment.

Timeline

Start
2018-03-31
Primary completion
2019-05-01
Completion
2021-06-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Acriflavine Unknown 15 mg
Comparator Atropa belladona Unknown 15 mg
Subject Methenamine Unknown 120 mg
Subject Methenamine Unknown 250 mg
Subject Methylthioninium Unknown 20 mg