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Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

NCT ID: NCT03379389

Last Updated: 2021-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

284 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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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). After initial evaluations including urine culture and antibiogram, a total of 284 subjects will be randomized and treated with one of two presentations of urinary antiseptics containing methenamine and methylthioninium for six days. After three days of treatment, subjects will return to the study center and antibiotic therapy based on the results of the urine culture and antibiogram will be initiated for each subject, to be continued for the remaining three days of the treatment period. Efficacy assessments will include the UTISA (Urinary Tract Infection Symptoms Assessment Questionnaire) together with a global assessment by the investigator. Safety assessments will include monitoring of adverse events and laboratory tests carried out at each of the three study visits.

Conditions

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Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Methenamine + Methylthioninium

Dosage: Methenamine (120mg) + Methylthioninium (20mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days

Group Type EXPERIMENTAL

Methenamine + Methylthioninium

Intervention Type DRUG

Methenamine + Methylthioninium

Antibiotics

Intervention Type DRUG

Antibiotics based on individual subjects urine culture / antibiogram

Methenamine+Methylthioninium+Acriflavine+Atropa belladona

Dosage: Methenamine (250mg) + Methylthioninium (20mg) + Acriflavine hydrochloride (15mg) + Atropa belladonna L. (15mg) Dosage form: coated tablets Frequency: 2 coated tablets twice daily Duration: 6 days

Group Type ACTIVE_COMPARATOR

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Intervention Type DRUG

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Antibiotics

Intervention Type DRUG

Antibiotics based on individual subjects urine culture / antibiogram

Interventions

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Methenamine + Methylthioninium

Methenamine + Methylthioninium

Intervention Type DRUG

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

Intervention Type DRUG

Antibiotics

Antibiotics based on individual subjects urine culture / antibiogram

Intervention Type DRUG

Other Intervention Names

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methenamine + methylene blue methenamine + methylene blue + acriflavine + A. belladona Antimicrobials

Eligibility Criteria

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Inclusion Criteria

* Patients of both sexes, age ≥18
* Clinical diagnosis of recurrent cystitis (≥ 2 episodes in the past 6 months)
* Female subject of reproductive age not pregnant, agrees to use birth control during study period
* Subject has read, understood, signed and dated informed consent document

Exclusion Criteria

* History of nephritis or kidney stones
* History of hepatic or gastrointestinal disease
* Diabetes
* Glaucoma
* Female subjects: pregnancy or breastfeeding
* History of anatomical alterations contributing to recurring cystitis on imaging exams
* Hypersensitivity to any component of study drug
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundação Educacional Serra dos Órgãos

OTHER

Sponsor Role lead

Responsible Party

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Carlos Pereira Nunes

Professor of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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carlos p nunes, MD

Role: PRINCIPAL_INVESTIGATOR

Fundação Educacional Serra dos Órgãos

Locations

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Centro Universitário Serra dos Órgãos - UNIFESO

Teresópolis, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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AUCR-01-05-17

Identifier Type: -

Identifier Source: org_study_id