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Participants receiving Gepotidacin for Gonorrhea

Phase 3
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and from day 4 to day 8
Awards & highlights

Study Summary

This trial will compare the effectiveness and safety of oral Gepotidacin to IM ceftriaxone plus oral azithromycin for the treatment of uncomplicated urogenital infection caused by Neisseria gonorrhoeae in adolescent and adult subjects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and from day 4 to day 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and from day 4 to day 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with culture-confirmed bacterial eradication of Neisseria gonorrhoeae from the urogenital site at the Test-of-Cure (TOC)
Secondary outcome measures
Change from Baseline in albumin and total protein levels (Grams per liter)
Change from Baseline in aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase levels (International units per Liter)
Change from Baseline in blood urea nitrogen, glucose non-fasting, calcium, chloride, sodium, magnesium and potassium levels (Millimoles per Liter)
+15 more

Side effects data

From 2022 Phase 3 trial • 1531 Patients • NCT04020341
14%
Diarrhoea
11%
Nausea
3%
Abdominal pain upper
2%
Flatulence
2%
Faeces soft
2%
Headache
1%
Dizziness
1%
Urinary tract infection
1%
Vomiting
1%
Aspartate aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Gepotidacin
Nitrofurantoin

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Participants receiving GepotidacinExperimental Treatment1 Intervention
Participants will receive Gepotidacin orally at the study site during the Baseline (Day 1) visit followed by self-administration of a second oral dose as an outpatient 10 to 12 hours after the first dose.
Group II: Participants receiving Ceftriaxone plus AzithromycinActive Control2 Interventions
Participants will receive a single IM dose of Ceftriaxone plus a single oral dose of Azithromycin at the study site during the Baseline (Day 1) visit.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gepotidacin
2020
Completed Phase 3
~4020

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,066,844 Total Patients Enrolled
2 Trials studying Gonorrhea
880 Patients Enrolled for Gonorrhea
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,302 Total Patients Enrolled
1 Trials studying Gonorrhea
106 Patients Enrolled for Gonorrhea

Media Library

Azithromycin (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04010539 — Phase 3
Gonorrhea Research Study Groups: Participants receiving Gepotidacin, Participants receiving Ceftriaxone plus Azithromycin
Gonorrhea Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04010539 — Phase 3
Azithromycin (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04010539 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What infections does Gepotidacin work best against?

"In addition to intraabdominal infections, Gepotidacin is commonly used to treat chlamydia, streptococcus agalactiae infection, and other conditions in adult patients."

Answered by AI

Does Gepotidacin have a long history of being studied in humans?

"Gepotidacin was first researched in 2014 at Affiliated Hospital of Shandong University of TCM. Since then, there have been 303 completed studies and currently 73 ongoing trials. A considerable amount of these active studies are based in San Francisco, California."

Answered by AI

When might Gepotidacin gain FDA approval in the USA?

"Given that this is a Phase 3 trial with supporting data for efficacy and safety, our team at Power has rated Gepotidacin's safety as a 3."

Answered by AI

How many willing individuals are taking part in this research?

"That is right, the clinicaltrials.gov website says that this trial is looking for more patients. The listing was made on October 21st 2019 and was last updated 14th of October in 2022. There are 600 open spots at 14 different facilities."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

In case you have a control group or something that you’d like to use for a placebo.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
2019. "A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04010539.
~116 spots leftby Apr 2025
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