drugset / Trial / NCT03379389
Clinical Assessment of Urinary Antiseptics Methenamine and Methylthioninium in Recurrent Cystitis
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2018-03-31
- Primary completion
- 2019-05-01
- Completion
- 2021-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Acriflavine | Unknown | 15 mg | — |
| Comparator | Atropa belladona | Unknown | 15 mg | — |
| Subject | Methenamine | Unknown | 120 mg | — |
| Subject | Methenamine | Unknown | 250 mg | — |
| Subject | Methylthioninium | Unknown | 20 mg | — |