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NCT06597344 · ClinicalTrials.gov registry record · Phase 3
A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 97
- Enrollment target
NCT06597344: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT06597344 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 97 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06597344, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 97 participants
- Enrollment target
Study Summary
The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
Primary Outcome
Clinical Symptom improvement is defined as a decrease from Baseline in CSS (Clinical Symptom Score) total score of at least 1 point at 24 hours (±4 hours), without the need for other systemic antimicrobials. CSS Score ranges from 0 to 12. Higher scores indicate a higher presence and severity of UTI symptoms.
Interventions
- DRUG Gepotidacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2024-10-02 |
| Est. Completion | 2025-03-10 |
| Phase | Phase 3 |
What the finished NCT06597344 record still lists
NCT06597344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Gepotidacin is the first listed.
NCT06597344 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06597344 about?
NCT06597344 is a clinical study titled "A Study in Adolescent and Adult Female Participants to Evaluate Clinical Symptom Improvement and the Safety of Gepotidacin During Treatment of Uncomplicated Urinary Tract Infections (Acute Cystitis)". The study will be conducted to evaluate the clinical symptom improvement and safety of oral gepotidacin for treatment of uncomplicated UTI (acute cystitis) in adolescent and adult female participants.
What is the current status of trial NCT06597344?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 97 participants. The study started on 2024-10-02. Estimated completion is 2025-03-10.
What interventions are being tested in trial NCT06597344?
The interventions under investigation include: Gepotidacin (DRUG).
Who is sponsoring clinical trial NCT06597344?
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 NCT06597344's enrollment target sits among peer trials
97 1718th of 2000 higher than 283 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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