Status:
COMPLETED
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
Lead Sponsor:
Fundação Educacional Serra dos Órgãos
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 randomize...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2021
Estimated Enrollment :
284 Patients enrolled
Trial Details
Trial ID
NCT03379389
Start Date
March 31 2018
End Date
June 1 2021
Last Update
December 14 2021
Active Locations (1)
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1
Centro Universitário Serra dos Órgãos - UNIFESO
Teresópolis, Rio de Janeiro, Brazil, 25964004