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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,606 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,606 participants |
| Start Date | 2020-04-23 |
| Est. Completion | 2022-12-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗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.
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