A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)
Public ClinicalTrials.gov record NCT04020341. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Multicenter, Parallel-Group, Double-Blind, Double-Dummy Study in Adolescent and Adult Female Participants Comparing the Efficacy and Safety of Gepotidacin to Nitrofurantoin in the Treatment of Uncomplicated Urinary Tract Infection (Acute Cystitis)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04020341
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,531 participants
Conditions and interventions
Conditions
Interventions
- Gepotidacin Drug
- Placebo matching nitrofurantoin Drug
- Nitrofurantoin Drug
- Placebo matching gepotidacin Drug
Drug
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 17, 2019 (Actual)
- Primary completion
- Nov 30, 2022 (Actual)
- Completion
- Nov 30, 2022 (Actual)
- Last update posted
- Jun 22, 2023
2019 – 2022
United States locations
- U.S. sites
- 41
- U.S. states
- 17
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35205 | — |
| GSK Investigational Site | Phoenix | Arizona | 85051 | — |
| GSK Investigational Site | Tucson | Arizona | 85712 | — |
| GSK Investigational Site | Beverly Hills | California | 90211-2921 | — |
| GSK Investigational Site | Chula Vista | California | 91911 | — |
| GSK Investigational Site | La Mesa | California | 91942 | — |
| GSK Investigational Site | Lomita | California | 90717 | — |
| GSK Investigational Site | Long Beach | California | 90806 | — |
| GSK Investigational Site | Northridge | California | 91324-3331 | — |
| GSK Investigational Site | Northridge | California | 91324-3528 | — |
| GSK Investigational Site | Palm Springs | California | 92264 | — |
| GSK Investigational Site | San Diego | California | 92120 | — |
| GSK Investigational Site | DeLand | Florida | 32720 | — |
| GSK Investigational Site | Hialeah | Florida | 33016 | — |
| GSK Investigational Site | Miami | Florida | 33144 | — |
| GSK Investigational Site | Miami Springs | Florida | 33166 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Pompano Beach | Florida | 33060 | — |
| GSK Investigational Site | Atlanta | Georgia | 30328 | — |
| GSK Investigational Site | Columbus | Georgia | 31901-2561 | — |
| GSK Investigational Site | Fayetteville | Georgia | 31204 | — |
| GSK Investigational Site | Wichita | Kansas | 67226-3007 | — |
| GSK Investigational Site | New Orleans | Louisiana | 70115 | — |
| GSK Investigational Site | Shreveport | Louisiana | 71106 | — |
| GSK Investigational Site | Watertown | Massachusetts | 02472 | — |
| GSK Investigational Site | Dearborn Heights | Michigan | 48127-3163 | — |
| GSK Investigational Site | Norfolk | Nebraska | 68701-2669 | — |
| GSK Investigational Site | East Brunswick | New Jersey | 08816-1407 | — |
| GSK Investigational Site | Albuquerque | New Mexico | 87109 | — |
| GSK Investigational Site | Endwell | New York | 13760 | — |
| GSK Investigational Site | Fayetteville | North Carolina | 28304 | — |
| GSK Investigational Site | Scottdale | Pennsylvania | 15683 | — |
| GSK Investigational Site | Smithfield | Pennsylvania | 15478 | — |
| GSK Investigational Site | Clarksville | Tennessee | 37043-1524 | — |
| GSK Investigational Site | Memphis | Tennessee | 38120 | — |
| GSK Investigational Site | Arlington | Texas | 76014 | — |
| GSK Investigational Site | Austin | Texas | 78705 | — |
| GSK Investigational Site | Corpus Christi | Texas | 78414 | — |
| GSK Investigational Site | Forney | Texas | 75126 | — |
| GSK Investigational Site | Houston | Texas | 77055 | — |
| GSK Investigational Site | Houston | Texas | 77065-5597 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 62 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04020341, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2023 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04020341 live on ClinicalTrials.gov.