clinical trial · NCT05630833
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
GlaxoSmithKline·phase3·completed·n = 380
Urinary Tract InfectionsGepotidacinNitrofurantoinPlacebo
brief 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 \[NCT04187144\]).
started
Jan 11, 2023
primary completion
Feb 2, 2024
completion
Feb 2, 2024
last updated
Mar 17, 2025
official title
A Phase III, Multicenter, Randomized, Active Reference, Double Blind, Double-dummy Study in Japanese Female Participants to Evaluate the Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol