Trials / Completed
CompletedNCT05630833
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- Female
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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 \[NCT04187144\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gepotidacin | Gepotidacin will be administered. |
| DRUG | Nitrofurantoin | Nitrofurantoin will be administered. |
| DRUG | Placebo | Placebo will be administered. |
Timeline
- Start date
- 2023-01-11
- Primary completion
- 2024-02-02
- Completion
- 2024-02-02
- First posted
- 2022-11-30
- Last updated
- 2025-03-17
- Results posted
- 2025-03-17
Locations
27 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05630833. Inclusion in this directory is not an endorsement.