Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04020341 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,531
- Enrollment target
NCT04020341: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04020341 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,531 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04020341, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,531 participants
- Enrollment target
Study Summary
The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Primary Outcome
Therapeutic response (success/failure) is a measure of the overall efficacy response. A therapeutic success referred to participants who had been deemed both a "microbiological success"(reduction of all qualifying bacterial uropathogens \[greater than or equal to {\>=}10\^5 colony-forming units per milliliter {CFU/mL}\] recovered at Baseline to less than (\<)10\^3 CFU/mL as observed on quantitative urine culture without the participant receiving other systemic antimicrobials before the TOC Visit
Interventions
- DRUG Nitrofurantoin
- DRUG Gepotidacin
- DRUG Placebo matching nitrofurantoin
- DRUG Placebo matching gepotidacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,531 participants |
| Start Date | 2019-10-17 |
| Est. Completion | 2022-11-30 |
| Phase | Phase 3 |
What the finished NCT04020341 record still lists
NCT04020341 is an interventional study that assigns participants to a tested intervention. Its 1,531 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% higher).
The record links to 0 conditions, and to 4 interventions - of which Nitrofurantoin is the first listed.
NCT04020341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04020341 about?
NCT04020341 is a clinical study titled "A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)". The study will be conducted to evaluate the therapeutic response (combined per participant microbiological and clinical response) of oral gepotidacin compared to oral nitrofurantoin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
What is the current status of trial NCT04020341?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,531 participants. The study started on 2019-10-17. Estimated completion is 2022-11-30.
What interventions are being tested in trial NCT04020341?
The interventions under investigation include: Nitrofurantoin (DRUG), Gepotidacin (DRUG), Placebo matching nitrofurantoin (DRUG), Placebo matching gepotidacin (DRUG).
Who is sponsoring clinical trial NCT04020341?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04020341's enrollment target sits among peer trials
1,531 154th of 2000 higher than 1,847 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06393374 · 1,530 participants · Phase 3
Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
- NCT07114510 · 1,530 participants · NA
Optimal Ventilation for Cardiac Arrest
- NCT06623097 · 1,528 participants · NA
Exercise and Nutrition for Older Cancer Survivors and Their Support Person: The Vitality Study
- NCT06842875 · 1,536 participants · NA
Rhode Island - Statewide Postpartum Hypertension Remote Surveillance
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI