CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 380 enrolled
Drug / intervention
Gepotidacin +2 moredrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Body weight ≥40 kg
  • ✓≥2 clinical signs/symptoms of acute cystitis (dysuria, frequency, urgency, lower abdominal pain) with onset <96 hours
  • ✓Pyuria (>15 WBC/HPF or 3+ leukocyte esterase) or nitrite on urinalysis
Key exclusion· 24
  • ✕Nursing home or dependent care facility resident
  • ✕BMI ≥40 kg/m² or ≥35 kg/m² with obesity-related health conditions (uncontrolled hypertension or diabetes)
  • ✕Immunocompromised or altered immune defenses
  • ✕Poorly controlled asthma/COPD, active peptic ulcer, Parkinson disease, myasthenia gravis, seizure disorder requiring medication, or acute porphyria

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05630833
NCT05630833Phase 3Completed
CompareCT.gov

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)

GlaxoSmithKline·interventional·Posted Nov 30, 2022·Updated Mar 17, 2025

In Brief

A Phase 3 clinical trial evaluating Gepotidacin, Nitrofurantoin, and 1 other intervention for Urinary Tract Infections. Completed, enrolled 380 participants across 27 sites.

Detailed 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 \[NCT04187144\]).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUrinary Tract Infections
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedNov 30, 2022
Enrollment StartJan 11, 2023
Primary CompletionFeb 2, 2024
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 3.6 years ago

Interventions

Gepotidacindrug

Gepotidacin will be administered.

Nitrofurantoindrug

Nitrofurantoin will be administered.

Placebodrug

Placebo will be administered.