A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)

PHASE3CompletedINTERVENTIONAL
Enrollment

1,531

Participants

Timeline

Start Date

October 17, 2019

Primary Completion Date

November 30, 2022

Study Completion Date

November 30, 2022

Conditions
Urinary Tract Infections
Interventions
DRUG

Gepotidacin

Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.

DRUG

Placebo matching nitrofurantoin

Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.

DRUG

Nitrofurantoin

Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Each dose should be taken with water after consumption of food.

DRUG

Placebo matching gepotidacin

Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Each dose should be taken with water after consumption of food.

Trial Locations (103)

1000

GSK Investigational Site, Sofia

1408

GSK Investigational Site, Sofia

1431

GSK Investigational Site, Sofia

2600

GSK Investigational Site, Dupnitsa

2700

GSK Investigational Site, Blagoevgrad

4000

GSK Investigational Site, Plovdiv

4400

GSK Investigational Site, Nyíregyháza

4700

GSK Investigational Site, Smolyan

5800

GSK Investigational Site, Pernik

GSK Investigational Site, Pleven

5905

GSK Investigational Site, Orosháza-Szentetornya

6035

GSK Investigational Site, Ballószög

6640

GSK Investigational Site, Csongrád

8600

GSK Investigational Site, Yambol

8800

GSK Investigational Site, Sliven

10439

GSK Investigational Site, Berlin

13760

GSK Investigational Site, Endwell

15478

GSK Investigational Site, Smithfield

15683

GSK Investigational Site, Scottdale

20146

GSK Investigational Site, Hamburg

28023

GSK Investigational Site, Madrid

28041

GSK Investigational Site, Madrid

28044

GSK Investigational Site, Madrid

28050

GSK Investigational Site, Madrid

28304

GSK Investigational Site, Fayetteville

30328

GSK Investigational Site, Atlanta

31204

GSK Investigational Site, Fayetteville

32720

GSK Investigational Site, DeLand

32806

GSK Investigational Site, Orlando

33016

GSK Investigational Site, Hialeah

33060

GSK Investigational Site, Pompano Beach

33144

GSK Investigational Site, Miami

33166

GSK Investigational Site, Miami Springs

35205

GSK Investigational Site, Birmingham

35385

GSK Investigational Site, Giessen

38120

GSK Investigational Site, Memphis

41110

GSK Investigational Site, Larissa

44130

GSK Investigational Site, Jalisco

44160

GSK Investigational Site, Guadalajara

44280

GSK Investigational Site, Guadalajara

45355

GSK Investigational Site, Essen

45468

GSK Investigational Site, Mülheim

46026

GSK Investigational Site, Valencia

54635

GSK Investigational Site, Thessaloniki

56403

GSK Investigational Site, Thessaloniki

64000

GSK Investigational Site, Monterrey

64460

GSK Investigational Site, Monterrey

70115

GSK Investigational Site, New Orleans

71106

GSK Investigational Site, Shreveport

71110

GSK Investigational Site, Heraklion

75126

GSK Investigational Site, Forney

76014

GSK Investigational Site, Arlington

76800

GSK Investigational Site, San Juan del Río

77055

GSK Investigational Site, Houston

78414

GSK Investigational Site, Corpus Christi

78705

GSK Investigational Site, Austin

85051

GSK Investigational Site, Phoenix

85712

GSK Investigational Site, Tucson

87109

GSK Investigational Site, Albuquerque

90717

GSK Investigational Site, Lomita

90806

GSK Investigational Site, Long Beach

91911

GSK Investigational Site, Chula Vista

91942

GSK Investigational Site, La Mesa

92120

GSK Investigational Site, San Diego

92264

GSK Investigational Site, Palm Springs

140044

GSK Investigational Site, Córdoba

221010

GSK Investigational Site, Varanasi

300736

GSK Investigational Site, Timișoara

380016

GSK Investigational Site, Ahmedabad

395002

GSK Investigational Site, Surat

410469

GSK Investigational Site, Oradea

700116

GSK Investigational Site, Iași

90211-2921

GSK Investigational Site, Beverly Hills

91324-3331

GSK Investigational Site, Northridge

91324-3528

GSK Investigational Site, Northridge

31901-2561

GSK Investigational Site, Columbus

67226-3007

GSK Investigational Site, Wichita

02472

GSK Investigational Site, Watertown

48127-3163

GSK Investigational Site, Dearborn Heights

68701-2669

GSK Investigational Site, Norfolk

08816-1407

GSK Investigational Site, East Brunswick

37043-1524

GSK Investigational Site, Clarksville

77065-5597

GSK Investigational Site, Houston

305 99

GSK Investigational Site, Bory

767 01

GSK Investigational Site, Kromeríž

120 00

GSK Investigational Site, Prague

546 42

GSK Investigational Site, Thessaloniki

06100

GSK Investigational Site, Ciudad de Mexico

021105

GSK Investigational Site, Bucharest

022328

GSK Investigational Site, Bucharest

050653

GSK Investigational Site, Bucharest

851 05

GSK Investigational Site, Bratislava

040 01

GSK Investigational Site, Košice

949 01

GSK Investigational Site, Nitra

018 52

GSK Investigational Site, Pruské

927 01

GSK Investigational Site, Šaľa

911 01

GSK Investigational Site, Trenčín

911 05

GSK Investigational Site, Trenčín

03010

GSK Investigational Site, Alicante

08500

GSK Investigational Site, Vic

PL5 3JB

GSK Investigational Site, Crownhill, Plymouth

PL14 3XA

GSK Investigational Site, Liskeard

PE8 6PL

GSK Investigational Site, Peterborough

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY