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NCT04187144 · ClinicalTrials.gov registry record · Phase 3
Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,606
- Enrollment target
NCT04187144: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT04187144 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,606 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04187144, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,606 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
TR at TOC (success/failure) is a measure of the overall efficacy response. A therapeutic success at TOC referred to participant who have been deemed both a microbiological success (reduction of all qualifying bacterial uropathogens recovered at Baseline \[BL\] to \<10\^3 colony forming units per milliliter \[CFU/mL\] without receiving other systemic antimicrobials \[AB\] before the TOC visit) and a clinical success (resolution of symptoms of acute cystitis present at BL and no symptoms without r
Interventions
- DRUG Nitrofurantoin
- DRUG Gepotidacin
- DRUG Placebo matching nitrofurantoin
- DRUG Placebo matching gepotidacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,606 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 3 |
What the finished NCT04187144 record still lists
NCT04187144 is an interventional study that assigns participants to a tested intervention. Its 1,606 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 (108% higher).
The record links to 0 conditions, and to 4 interventions - of which Nitrofurantoin is the first listed.
NCT04187144 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04187144 about?
NCT04187144 is a clinical study titled "Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in 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 NCT04187144?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,606 participants. The study started on 2020-04-23. Estimated completion is 2022-12-01.
What interventions are being tested in trial NCT04187144?
The interventions under investigation include: Nitrofurantoin (DRUG), Gepotidacin (DRUG), Placebo matching nitrofurantoin (DRUG), Placebo matching gepotidacin (DRUG).
Who is sponsoring clinical trial NCT04187144?
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 NCT04187144's enrollment target sits among peer trials
1,606 142nd of 2000 higher than 1,859 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
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