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
Location: See all (27) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 \[NCT04187144\]).

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 12
Healthy Volunteers: f
View:

• The participant has a body weight \>=40 kilograms (kg).

• The participant has 2 or more of the following clinical signs and symptoms of acute cystitis with onset less than (\<) 96 hours prior to study entry: dysuria, frequency, urgency, or lower abdominal pain.

• The participant has nitrite or pyuria (greater than \[\>\]15 white blood cell \[WBC\]/high-power field \[HPF\] or the presence of 3 plus (+) /large leukocyte esterase) from a pretreatment clean-catch midstream urine sample based on local laboratory procedures.

• The participant is capable of giving signed informed consent/assent.

Locations
Other Locations
Japan
GSK Investigational Site
Chiba
GSK Investigational Site
Chiba
GSK Investigational Site
Chiba
GSK Investigational Site
Chiba
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Fukuoka
GSK Investigational Site
Gunma
GSK Investigational Site
Hokkaido
GSK Investigational Site
Ibaraki
GSK Investigational Site
Ibaraki
GSK Investigational Site
Kagoshima
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kanagawa
GSK Investigational Site
Kochi
GSK Investigational Site
Miyagi
GSK Investigational Site
Osaka
GSK Investigational Site
Osaka
GSK Investigational Site
Saga
GSK Investigational Site
Saitama
GSK Investigational Site
Saitama
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
GSK Investigational Site
Tokyo
Time Frame
Start Date: 2023-01-11
Completion Date: 2024-02-02
Participants
Target number of participants: 380
Treatments
Experimental: Gepotidacin + Placebo
Active_comparator: Nitrofurantoin + Placebo
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov