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Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

NCT03379389 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 284

Last updated 2021-12-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Methenamine + Methylthioninium

Methenamine + Methylthioninium

DRUG

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

DRUG

Antibiotics

Antibiotics based on individual subjects urine culture / antibiogram

Sponsors & Collaborators

  • Fundação Educacional Serra dos Órgãos

    lead OTHER

Principal Investigators

  • carlos p nunes, MD · Fundação Educacional Serra dos Órgãos

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03379389 on ClinicalTrials.gov