Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

NCTNCT03379389Other idAUCR-01-05-17

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 284 participants (actual)
Sponsor: Fundação Educacional Serra dos Órgãos · Other
Design: Randomized · Quadruple masking
Countries: 1 country
Brazil
Start: 31 Mar 2018
Primary completion: 1 May 2019
Completion: 1 Jun 2021
First posted: 20 Dec 2017
Last update posted: 14 Dec 2021
Conditions: Urinary Tract Infections

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182019202020212022

Ph 4
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
NCT03379389
31 Mar 2018 to 1 Jun 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Methenamine + MethylthioniniumDrug
Methenamine + Methylthioninium + Acriflavine + Atropa belladonaDrug
AntibioticsDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Urination regularity
Time frame · Following three days of treatment with urinary antiseptics
Registry description
Percentage of subjects presenting improvement in cystitis symptoms in the "Urination Regularity" domain of the UTISA at Visit 2.

Secondary outcomes(9)

Total UTISA score
Time frame · From pretreatment to final visit, total of 6 days of treatment
Registry description
Evolution of total UTISA score at end of study compared to pretreatment in each treatment group
UTISA question # 9
Time frame · At Visit 2, after 3 days of treatment
Registry description
Percentage of subjects with improvement in UTISA question 9 at Visit 2 in each treatment group
Adverse events
Time frame · From pretreatment to final visit, total of 6 days of treatment
Registry description
Incidence of study drug-related adverse events in each treatment group
Problems with Urination at Visit 2
Time frame · After 3 days of treatment
Registry description
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Problems with Urination at Visit 3
Time frame · After 6 days of treatment
Registry description
Evolution of UTISA domain "Problems with Urination" in each treatment Group
Pain Associated with UTI at Visit 2
Time frame · After 3 days of treatment
Registry description
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Pain Associated with UTI at Visit 3
Time frame · After 6 days of treatment
Registry description
Evolution of UTISA domain "Pain Associated with UTI" in each treatment Group
Blood in Urine at Visit 2
Time frame · After 3 days of treatment
Registry description
Evolution of UTISA domain "Blood in Urine" in each treatment Group
Blood in Urine at Visit 3
Time frame · After 6 days of treatment
Registry description
Evolution of UTISA domain "Blood in Urine" in each treatment Group

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 80 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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