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NCT04010539 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
A Phase 3 study of Gonorrhea, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 628
- Enrollment target
- 20
- Study locations
NCT04010539: Completed Phase 3 study of Gonorrhea, sponsored by GlaxoSmithKline.
NCT04010539 is a Phase 3 study of Gonorrhea that has completed, run by GlaxoSmithKline. The registered enrollment target is 628 participants, below the 1,383-participant average among 10 other Gonorrhea trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04010539, a Phase 3 study of Gonorrhea, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 628 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gonorrhoeae) in adolescent and adult participants. In this study, participants will be randomly assigned to receive either oral gepotidacin or IM ceftriaxone plus oral azithromycin.
Primary Outcome
Urogenital specimens were obtained for bacteriological culture at the Baseline (Day 1) and TOC (Day 4 to 8) visits and were compared to determine microbiological outcome. Microbiological success was defined as culture-confirmed elimination of baseline pathogen (NG) from a bacteriology sample taken at the TOC visit without the participant receiving other systemic antimicrobials before this visit. Microbiological failure was categorized as "Bacterial Persistence (BP)" and "Unable to Determine (UTD
Conditions Studied
Interventions
- DRUG Azithromycin
- DRUG Ceftriaxone
- DRUG Gepotidacin
Study Locations (20)
California
- GSK Investigational Site - Los Angeles
- GSK Investigational Site - Palm Springs
Florida
- GSK Investigational Site - DeLand
- GSK Investigational Site - Orlando
North Carolina
- GSK Investigational Site - Fayetteville
- GSK Investigational Site - Greensboro
Texas
- GSK Investigational Site - Houston
- GSK Investigational Site - Longview
New South Wales
- GSK Investigational Site - Darlinghurst
- GSK Investigational Site - Darlinghurst, Sydney
Victoria
- GSK Investigational Site - Carlton
- GSK Investigational Site - Prahran
Georgia
- GSK Investigational Site - Decatur
Indiana
- GSK Investigational Site - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 628 participants |
| Start Date | 2019-10-21 |
| Est. Completion | 2023-10-10 |
| Phase | Phase 3 |
What the finished NCT04010539 record still lists
NCT04010539 is an interventional study that assigns participants to a tested intervention. The registered 628 participants enrollment target is mid-sized for trials with a published cap, below the 1,383-participant average among 10 other Gonorrhea trials with a reported enrollment target (55% lower).
The record links to 1 condition, with Gonorrhea appearing as the primary indexed condition, and to 3 interventions - of which Azithromycin is the first listed.
NCT04010539 names 20 study sites across 14 states, led by California, Florida, North Carolina.
Frequently Asked Questions
What is clinical trial NCT04010539 about?
NCT04010539 is a clinical study titled "A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea". This is a phase III, randomized, multicenter, open-label study which will be performed to evaluate efficacy and safety of oral Gepotidacin compared to intramuscular (IM) ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae (N. gon...
What is the current status of trial NCT04010539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 628 participants. The study started on 2019-10-21. Estimated completion is 2023-10-10.
What conditions does trial NCT04010539 study?
This clinical trial studies the following conditions: Gonorrhea.
What interventions are being tested in trial NCT04010539?
The interventions under investigation include: Azithromycin (DRUG), Ceftriaxone (DRUG), Gepotidacin (DRUG).
Who is sponsoring clinical trial NCT04010539?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04010539 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04010539's enrollment target sits among peer trials
628 3rd of 10 higher than 8 of 10 other Gonorrhea trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gonorrhea 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.
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