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Placebo matching gepotidacin

DRUG2 trials

Sponsors

GlaxoSmithKline

Conditions

Urinary Tract Infections

Phase 3

A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
CompletedNCT04020341
GlaxoSmithKlineUrinary Tract Infections
Start: 2019-10-17End: 2022-11-30Updated: 2023-06-22
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
CompletedNCT04187144
GlaxoSmithKlineUrinary Tract Infections
Start: 2020-04-23End: 2022-12-01Updated: 2023-07-18

Related Papers

Early symptom response in patients with uncomplicated urinary tract infection treated with gepotidacin or nitrofurantoin: pooled analysis from two pivotal Phase 3 studies.
2026-01-06
P-1191. A Phase 3b, Open-label, Single-arm Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (uUTIs)
Open Forum Infectious Diseases2026-01-01
Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3.
2025-11-18
Multi-Platform analytics integration for clinical trial Recruitment: A digital health informatics implementation framework.
2025-11-08
Efficacy and <i>in vitro</i> activity of gepotidacin against bacterial uropathogens, including drug-resistant phenotypes, in females with uncomplicated urinary tract infections: results from two global, pivotal, phase 3 trials (EAGLE-2 and EAGLE-3)
Antimicrobial Agents and Chemotherapy2025-09-092 citations
Efficacy and <i>in vitro</i> activity of gepotidacin against bacterial uropathogens, including subsets with molecularly characterized resistance mechanisms and genotypes/epidemiological clones, in females with uncomplicated urinary tract infections: results from two global, pivotal, phase 3 trials (EAGLE-2 and EAGLE-3)
Antimicrobial Agents and Chemotherapy2025-09-09
<i>In vitro</i> activity of gepotidacin against urinary tract infection isolates of Enterobacterales, <i>Enterococcus faecalis</i> , and <i>Staphylococcus saprophyticus</i>
Antimicrobial Agents and Chemotherapy2025-05-151 citations
P-1492. Patient Characteristics Associated with Extended-Spectrum Beta-Lactamase-Producing Uropathogens: Pooled Results from Two Phase 3 Clinical Trials of Gepotidacin for the Treatment of Uncomplicated Urinary Tract Infection
Open Forum Infectious Diseases2025-01-29
512. Efficacy of Gepotidacin versus Nitrofurantoin in a Nitrofurantoin Not Susceptible Population: A Pooled Analysis of the EAGLE-2 and EAGLE-3 Randomized Controlled Trials in Uncomplicated Urinary Tract Infection
Open Forum Infectious Diseases2025-01-29
P-1546. Discordant Clinical and Microbiological Responses are Associated with Late Clinical Relapse in Uncomplicated Urinary Tract Infections: Pooled Analysis of EAGLE-2/EAGLE-3 Trial Data
Open Forum Infectious Diseases2025-01-29
Oral gepotidacin versus nitrofurantoin in patients with uncomplicated urinary tract infection (EAGLE-2 and EAGLE-3): two randomised, controlled, double-blind, double-dummy, phase 3, non-inferiority trials.
2024-02-0856 citations
2837. Impact of Regulatory Guidelines on Therapeutic, Clinical, and Microbiological Success Rates in Uncomplicated Urinary Tract Infection: Results from a Two Phase 3 Randomized Controlled Trials of Oral Gepotidacin (EAGLE-2 and EAGLE-3)
Open Forum Infectious Diseases2023-11-27
Efficacy and Safety of Gepotidacin as Treatment of Uncomplicated Urogenital Gonorrhea (EAGLE-1): Design of a Randomized, Comparator-Controlled, Phase 3 Study
Infectious Diseases and Therapy2023-09-0122 citations
P31 Efficacy and safety of oral gepotidacin in the treatment of uncomplicated urinary tract infection: results of two randomized, multicentre Phase 3 trials (EAGLE-2 and EAGLE-3)
JAC-Antimicrobial Resistance2023-08-012 citations
Design of Two Phase III, Randomized, Multicenter Studies Comparing Gepotidacin with Nitrofurantoin for the Treatment of Uncomplicated Urinary Tract Infection in Female Participants
Infectious Diseases and Therapy2022-10-2125 citations
Novel Bacterial Topoisomerase Inhibitor Gepotidacin Demonstrates Absence of Fluoroquinolone-Like Arthropathy in Juvenile Rats.
2022-10-183 citations
Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects
Clinical and Translational Science2022-06-306 citations
Dose Selection for Phase III Clinical Evaluation of Gepotidacin (GSK2140944) in the Treatment of Uncomplicated Urinary Tract Infections.
2022-01-0334 citations
Pharmacokinetics of Oral Formulations of Gepotidacin (GSK2140944), a Triazaacenaphthylene Bacterial Type II Topoisomerase Inhibitor, in Healthy Adult and Adolescent Participants.
2021-10-1118 citations
Phase 2a Pharmacokinetic, Safety, and Exploratory Efficacy Evaluation of Oral Gepotidacin (GSK2140944) in Female Participants with Uncomplicated Urinary Tract Infection (Acute Uncomplicated Cystitis).
2020-06-2332 citations