NCT02292771 - A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labour | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 16, 2015

Primary Completion Date

August 25, 2017

Study Completion Date

August 25, 2017

Conditions

Obstetric Labour, Premature

Interventions

DRUG

Retosiban

Solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram/milliliter (mg/mL) in 56% volume/volume ethanol/acetate buffer concentrate supplied in 5 mL vial containing 75mg retosiban.

DRUG

Atosiban

Clear, colorless solution for injection in a 0.9-mL vial containing 6.75 mg of atosiban. Clear, colorless concentrate for solution for infusion in a 5-mL vial containing 37.5 mg atosiban.

DRUG

Placebo matching retosiban

A placebo infusion containing 0.9% sodium chloride (NaCl) matched for retosiban loading (bolus) dose and continuous infusion.

DRUG

Placebo matching atosiban

A placebo infusion containing 0.9% NaCl matched for the atosiban loading (bolus) dose and continuous infusion.

Trial Locations (21)

1200

GSK Investigational Site, Brussels

8000

GSK Investigational Site, Bruges

13100

GSK Investigational Site, Safed

20052

GSK Investigational Site, Monza

22087

GSK Investigational Site, Hamburg

31048

GSK Investigational Site, Haifa

44281

GSK Investigational Site, Kfar Saba

49100

GSK Investigational Site, Petah Tikva

50009

GSK Investigational Site, Zaragoza

53100

GSK Investigational Site, Siena

58100

GSK Investigational Site, Holon

64239

GSK Investigational Site, Tel Aviv

64460

GSK Investigational Site, Monterrey

79106

GSK Investigational Site, Freiburg im Breisgau

85000

GSK Investigational Site, Ciudad Obregón

463712

GSK Investigational Site, Sungnam

07743

GSK Investigational Site, Jena

120-752

GSK Investigational Site, Seoul

135-081

GSK Investigational Site, Seoul

SE-75185

GSK Investigational Site, Uppsala

S10 2JF

GSK Investigational Site, Sheffield