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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,531 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04020341
The ClinicalTrials.gov registry entry for NCT04020341 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,531 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.
NCT04020341 reports 0 study locations.
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.
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