A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea

PHASE3CompletedINTERVENTIONAL
Enrollment

628

Participants

Timeline

Start Date

October 21, 2019

Primary Completion Date

October 10, 2023

Study Completion Date

October 10, 2023

Conditions
Gonorrhea
Interventions
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.

Trial Locations (51)

2010

GSK Investigational Site, Darlinghurst

GSK Investigational Site, Darlinghurst, Sydney

3053

GSK Investigational Site, Carlton

3181

GSK Investigational Site, Prahran

4215

GSK Investigational Site, Southport

10243

GSK Investigational Site, Berlin

10439

GSK Investigational Site, Berlin

20146

GSK Investigational Site, Hamburg

27405

GSK Investigational Site, Greensboro

28010

GSK Investigational Site, Madrid

28034

GSK Investigational Site, Madrid

28040

GSK Investigational Site, Madrid

28046

GSK Investigational Site, Madrid

30033

GSK Investigational Site, Decatur

32720

GSK Investigational Site, DeLand

32803

GSK Investigational Site, Orlando

41013

GSK Investigational Site, Seville

44109

GSK Investigational Site, Cleveland

44160

GSK Investigational Site, Guadalajara

44280

GSK Investigational Site, Guadalajara

46202

GSK Investigational Site, Indianapolis

48010

GSK Investigational Site, Bilbao

50924

GSK Investigational Site, Cologne

60590

GSK Investigational Site, Frankfurt am Main

60596

GSK Investigational Site, Frankfurt am Main

64460

GSK Investigational Site, Monterrey

70119

GSK Investigational Site, New Orleans

75602

GSK Investigational Site, Longview

77098

GSK Investigational Site, Houston

80336

GSK Investigational Site, München

81675

GSK Investigational Site, Munich

90036

GSK Investigational Site, Los Angeles

92262

GSK Investigational Site, Palm Springs

01105

GSK Investigational Site, Springfield

28303-5537

GSK Investigational Site, Fayetteville

08036

GSK Investigational Site, Barcelona

08041

GSK Investigational Site, Barcelona

08950

GSK Investigational Site, Barcelona

?08015

GSK Investigational Site, Barcelona

?08907

GSK Investigational Site, Barcelona

B4 6DH

GSK Investigational Site, Birmingham

BN2 1ES

GSK Investigational Site, Brighton

EH3 9ES

GSK Investigational Site, Edinburgh

LS1 3EX

GSK Investigational Site, Leeds

E9 6SR

GSK Investigational Site, London

W2 1NY

GSK Investigational Site, London

W6 7AL

GSK Investigational Site, London

WC1E 6JB

GSK Investigational Site, London

M13 0FH

GSK Investigational Site, Manchester

RG1 5SL

GSK Investigational Site, Reading

WA9 3DA

GSK Investigational Site, St Helens

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY