Trials / Completed
CompletedNCT04010539
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
A Phase III, Randomized, Multicenter, Open-Label Study in Adolescent and Adult Participants Comparing the Efficacy and Safety of Gepotidacin to Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea Caused by Neisseria Gonorrhoeae
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 628 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gepotidacin | Gepotidacin will be administered as 3000 milligram (mg) oral dose (4 X 750 mg tablets) at the study site followed by 3000 mg oral dose (4 X 750 mg tablets) as an outpatient. Each dose should be taken after food consumption and with water. |
| DRUG | Ceftriaxone | Ceftriaxone is available as sterile powder for reconstitution. It will be administered as one 500-mg IM dose at the study site. |
| DRUG | Azithromycin | Azithromycin will be administered as 1000 mg oral dose (2 X 500 mg tablets) at the study site. Dose should be taken after food consumption and with water. |
Timeline
- Start date
- 2019-10-21
- Primary completion
- 2023-10-10
- Completion
- 2023-10-10
- First posted
- 2019-07-08
- Last updated
- 2024-05-30
- Results posted
- 2024-05-30
Locations
51 sites across 6 countries: United States, Australia, Germany, Mexico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04010539. Inclusion in this directory is not an endorsement.