Trial | NCT03379389  Report issue

Official Title

Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    284
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.
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.
Study Started
Mar 31
2018
Primary Completion
May 01
2019
Study Completion
Jun 01
2021
Last Update
Dec 14
2021

Drug Methenamine + Methylthioninium [methenamine, methylene blue (proveblue)]

Methenamine + Methylthioninium

  • Other names: methenamine + methylene blue

Drug Methenamine + Methylthioninium + Acriflavine + Atropa belladona [methenamine, methylene blue (proveblue), atropine, proflavine]

Methenamine + Methylthioninium + Acriflavine + Atropa belladona

  • Other names: methenamine + methylene blue + acriflavine + A. belladona

Drug Antibiotics

Antibiotics based on individual subjects urine culture / antibiogram

  • Other names: Antimicrobials

Methenamine + Methylthioninium Experimental

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

Methenamine+Methylthioninium+Acriflavine+Atropa belladona Active Comparator

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

Criteria 

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
No Results Posted