Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,606 participants.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Interventions

  • DRUG Nitrofurantoin
  • DRUG Gepotidacin
  • DRUG Placebo matching nitrofurantoin
  • DRUG Placebo matching gepotidacin

Trial Details

FieldValue
Enrollment Target 1,606 participants
Start Date 2020-04-23
Est. Completion 2022-12-01
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT04187144

The ClinicalTrials.gov registry entry for NCT04187144 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Nitrofurantoin is the first listed.

NCT04187144 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.