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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 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.

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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.

Conditions Studied

Gonorrhea

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

FieldValue
Enrollment Target 628 participants
Start Date 2019-10-21
Est. Completion 2023-10-10
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04010539

The ClinicalTrials.gov registry entry for NCT04010539 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 628 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,383-participant average among 10 other Gonorrhea trials with a reported enrollment target (55% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.