Completed
PHASE3
INTERVENTIONAL
NCT05630833
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
View on ClinicalTrials.gov
Updated Dec 15, 2025
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 \[NCT04187144\]).
Interventions
Name:
Gepotidacin
Type:
DRUG
Description:
Gepotidacin will be administered.
Name:
Nitrofurantoin
Type:
DRUG
Description:
Nitrofurantoin will be administered.
Name:
Placebo
Type:
DRUG
Description:
Placebo will be administered.
Primary Outcomes
Measure:
Number of Participants With Therapeutic Response (TR) (Combined Per-participant Microbiological and Clinical Success) for Gepotidacin at the Test of Cure (TOC) Visit
TimeFrame:
At TOC visit (Days 9 to 16)
Description:
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at BL to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no new symptoms without receiving other AB before the TOC visit \[or AB for uUTI on day of TOC visit\]). Lack of clinical or microbiological success (including missing outcome assessments) was considered as therapeutic failure.
Trial Information
NCT ID
NCT05630833
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
GlaxoSmithKline
Last Updated
December 15, 2025