drugset / Trial / NCT05630833
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the consistency of therapeutic response of gepotidacin in female participants with acute uncomplicated cystitis with qualifying bacterial uropathogen(s) at baseline that all are susceptible to nitrofurantoin in Japan, with that from global studies (Studies 204989 \[NCT04020341\] and 212390 \[NCT04187144\]).
Timeline
- Start
- 2023-01-11
- Primary completion
- 2024-02-02
- Completion
- 2024-02-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Gepotidacin | Small molecule | — | — |
| Comparator | Nitrofurantoin | Unknown | — | — |