A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor

PHASE3TerminatedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

July 24, 2017

Study Completion Date

July 24, 2017

Conditions
Obstetric Labour, Premature
Interventions
DRUG

Retosiban IV infusion

Retosiban for IV administration will be supplied as solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram per milliliter (mg/mL).

DRUG

Placebo IV infusion

0.9% NaCl matched for the retosiban loading dose and continuous infusion rates

Trial Locations (50)

10032

GSK Investigational Site, New York

10461

GSK Investigational Site, The Bronx

11201

GSK Investigational Site, Brooklyn

17601

GSK Investigational Site, Lancaster

20010

GSK Investigational Site, Washington D.C.

20132

GSK Investigational Site, Milan

22908

GSK Investigational Site, Charlottesville

27710

GSK Investigational Site, Durham

29425

GSK Investigational Site, Charleston

30912

GSK Investigational Site, Augusta

31904

GSK Investigational Site, Columbus

32209

GSK Investigational Site, Jacksonville

35233

GSK Investigational Site, Birmingham

36604

GSK Investigational Site, Mobile

37403

GSK Investigational Site, Chattanooga

40202

GSK Investigational Site, Louisville

44106

GSK Investigational Site, Cleveland

45409

GSK Investigational Site, Dayton

60068

GSK Investigational Site, Park Ridge

60153

GSK Investigational Site, Maywood

60611

GSK Investigational Site, Chicago

60637

GSK Investigational Site, Chicago

63117

GSK Investigational Site, Richmond Heights

66160

GSK Investigational Site, Kansas City

70115

GSK Investigational Site, New Orleans

85712

GSK Investigational Site, Tucson

92324

GSK Investigational Site, Colton

92868

GSK Investigational Site, Orange

97239

GSK Investigational Site, Portland

98431

GSK Investigational Site, Tacoma

39216-4505

GSK Investigational Site, Jackson

07753

GSK Investigational Site, Neptune City

07103

GSK Investigational Site, Newark

77555-0587

GSK Investigational Site, Galveston

N6A 4G5

GSK Investigational Site, London

00168

GSK Investigational Site, Rome

060-8543

GSK Investigational Site, Hokkaido

650-0047

GSK Investigational Site, Hyōgo

890-8760

GSK Investigational Site, Kagoshima

989-3126

GSK Investigational Site, Miyagi

889-1692

GSK Investigational Site, Miyazaki

856-8562

GSK Investigational Site, Nagasaki

904-2293

GSK Investigational Site, Okinawa

350-0495

GSK Investigational Site, Saitama

321-0293

GSK Investigational Site, Tochigi

135-8577

GSK Investigational Site, Tokyo

142-8666

GSK Investigational Site, Tokyo

157-8535

GSK Investigational Site, Tokyo

206-8512

GSK Investigational Site, Tokyo

SE1 7EH

GSK Investigational Site, London

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

GlaxoSmithKline

INDUSTRY

NCT02377466 - A Phase III Efficacy and Safety Study of Intravenous Retosiban Versus Placebo for Women in Spontaneous Preterm Labor | Biotech Hunter | Biotech Hunter