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COMPLETEDPHASE3

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)

NCT05630833•GlaxoSmithKline

View on ClinicalTrials.gov

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

Age

12 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•The participant resides in a nursing home or dependent care type facility.
•The participant has a body mass index \>=40.0 kilogram per meter square (kg/m\^2) or a body mass index \>=35.0 kg/m\^2 and is experiencing obesity-related health conditions such as uncontrolled high blood pressure or uncontrolled diabetes.
•The participant is immunocompromised or has altered immune defenses that may predispose the participant to a higher risk of treatment failure and/or complications.
•The participant has any of the following:
•* Poorly controlled asthma or chronic obstructive pulmonary disease; Acute severe pain; Active peptic ulcer disease; Parkinson disease; Myasthenia gravis; a history of seizure disorder requiring medications for control (this does not include a history of childhood febrile seizures); Or
•* Known acute porphyria.
•* Any surgical or medical condition (active or chronic) that may interfere with drug absorption, distribution, metabolism, or excretion of the study intervention.
•The participant has a known glucose-6-phosphate dehydrogenase deficiency.
•The participant, in the judgment of the investigator, would not be able or willing to comply with the protocol or complete study follow-up.
•The participant has acute uncomplicated cystitis that is known or suspected to be due to fungal, parasitic, or viral pathogens; or known or suspected to be due to Pseudomonas aeruginosa or Enterobacterales (other than E. coli) as the contributing pathogen.
+20 more criteria

Locations (27)

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Chiba, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Gunma, Japan

GSK Investigational Site

Hokkaido, Japan

Key Dates

Start Date

January 11, 2023

Primary Completion Date

February 2, 2024

Completion Date

February 2, 2024

Last Updated

March 17, 2025

Enrollment

380

ACTUAL participants

Conditions

Urinary Tract Infections

Interventions

Gepotidacin

DRUG

Nitrofurantoin

DRUG

Placebo

DRUG

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

NCT05488340

Urinary Tract Infections

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RECRUITINGNA

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Urinary Tract Infections (UTIs)

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)

Inclusion Criteria

Exclusion Criteria

A Study of LBP-EC01 in the Treatment of Acute Uncomplicated UTI Caused by Drug Resistant E. Coli (ELIMINATE Trial)

Evaluation of the Effectiveness and Safety of a Vaginal Gel for Prevention of Recurrent Urinary Tract Infections

Research of the Consequences on the Digestive Tract Following the Proposed Treatments for a Urinary Infection in Children

Ureteral Stent Exchange Abstention in Urinary Tract Infections

Vaginal Ecosystem and Network in the United States Study

PRObiotics for KIdney Transplantation