Terminated (Halted Prematurely)

Study Description:

The primary objective of this study is to demonstrate the superiority of retosiban to prolong pregnancy in females with spontaneous preterm labor compared with atosiban. This objective is based on the hypothesis that prolonging the time to delivery in the absence of harm may benefit the newborn, particularly in women who experience spontaneous preterm labor at early gestational ages (GA). This study is designed to test this hypothesis through a direct comparison with atosiban, a mixed oxytocin vasopressin antagonist indicated for short-term use to delay imminent preterm birth in women between 24^0/7 and 33^6/7 weeks’ gestation in preterm labor. This is a randomized, double-blind, double-dummy study, which consists of 6 phases: Screening, Inpatient Randomized Treatment, Post Infusion Assessment, Delivery, Maternal Post Delivery Assessment, and Neonatal Medical Review. Approximately 330 females will be randomly assigned to retosiban or atosiban treatment in a 1:1 ratio. The duration of any one subject’s (maternal or neonatal) participation in the study will be variable and dependent on GA at study entry and the date of delivery.

GSK Study ID:

200721


ClinicalTrials.gov Identifier:

NCT02292771


Has Results Available Below
EudraCT Number:

2014-001826-13


Study Overview

Medical Conditions

Women's Health & Pregnancy - Other

Product

GW407219;retosiban

Collaborators

PPD


Date

March 2015 to August 2017

Type

Interventional

Phase

3


Gender

Female

Age

12 years - 45 years

Accepts Healthy Volunteers

No


This study has Protocol and Result summary on ClinicalTrial.gov. Click here to learn more.

Locations

  • Central Contact :

    US GSK Clinical Trials Call Center

  • Central Contact Phone:

    877-379-3718

  • Central Contact Email:

    [email protected]

Belgium, Brugge 8000Completed
Belgium, Brussel 1090Terminated
Belgium, Bruxelles 1200Completed
Belgium, Bruxelles 1070Terminated
Belgium, Edegem 2650Terminated
Belgium, Genk 3600Terminated
Belgium, Gent 9000Terminated
Belgium, Leuven 3000Terminated
Brazil, Rio Grande Do Sul, Passo Fundo 333Terminated
Brazil, São Paulo, Ribeirao Preto 14048-900Terminated
Germany, Baden-Wuerttemberg, Freiburg 79106Completed
Germany, Bayern, München 81377Terminated
Germany, Hamburg, Hamburg 22087Completed
Germany, Niedersachsen, Hannover 30559Terminated
Germany, Niedersachsen, Hannover 30625Terminated
Germany, Schleswig-Holstein, Kiel 24105Terminated
Germany, Thueringen, Jena 07743Completed
Israel, Haifa 31048Completed
Israel, Holon 58100Completed
Israel, Kfar Saba 44281Completed
Israel, Petach Tikva 49100Completed
Israel, Safed 13100Completed
Israel, Tel Aviv 64239Completed
Italy, Brescia 25123Terminated
Italy, Monza 20052Completed
Italy, Perugia 06129Terminated
Italy, Lombardia, Milano 20154Terminated
Italy, Toscana, Siena 53100Completed
Mexico, Jalisco, Guadalajara 44340Terminated
Mexico, Nuevo León, Monterrey 64460Completed
Mexico, Sonora, Ciudad Obregon 85000Completed
South Korea, Seoul 135-081Completed
South Korea, Seoul 120-752Completed
South Korea, Seoul 100-380Terminated
South Korea, Seoul 3080Terminated
South Korea, Sungnam 463712Completed
Spain, Malaga 29011Terminated
Spain, Santiago 15705Terminated
Spain, Zaragoza 50009Completed
Spain, Madrid, Madrid 28046Terminated
Sweden, STOCKHOLM SE-17176Terminated
Sweden, UPPSALA SE-75185Completed
United Kingdom, London E1 2ATTerminated
United Kingdom, Manchester M8 5RBTerminated
United Kingdom, Middlesbrough TS4 3BWTerminated
United Kingdom, Oldham OL1 2JHTerminated
United Kingdom, Sheffield S10 2JFCompleted
United Kingdom, Tyne & Wear, Sunderland SR4 7TPTerminated

Study Design

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Study Design: Parallel Assignment
  • Study Classification: Not Available
  • Masking: Not Available
  • Masked Subject: Yes
  • Masked Caregiver: No
  • Masked Investigator: Yes
  • Masked Assessor: No
Primary Outcomes:

  • Time to delivery from the start of investigational product (IP) administration
    Timeframe: Up to 17 weeks

Secondary Outcomes:

  • Number of participants with births prior to 37 0/7 Weeks gestation
    Timeframe: Up to 13 weeks

  • Number of participants with births at term
    Timeframe: Up to 17 weeks

  • Length of neonatal hospital stay
    Timeframe: Up to 28 days post estimated date of delivery (EDD) of 40 0/7 weeks gestation

  • Number of neonates with composite neonatal morbidity and mortality
    Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

  • Number of neonates with any composite neonatal morbidity and mortality, excluding RDS
    Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

  • Number of neonates with each individual component of composite neonatal morbidity and mortality
    Timeframe: Up to 28 weeks after EDD (40 weeks gestation)

  • Length of stay in specialized care unit
    Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

  • Number of newborn participants with hospital readmission
    Timeframe: Up to 28 days of EDD (40 0/7 weeks gestation)

  • Number of participants with births prior to 28 0/7 weeks gestation
    Timeframe: Up to 4 weeks

  • Number of participants with births prior to 32 0/7 weeks gestation
    Timeframe: Up to 8 weeks

  • Number of participants with births prior to 35 0/7 weeks gestation
    Timeframe: Up to 11 weeks

  • Number of participants with births <=7 days from the first study treatment
    Timeframe: Up to 7 days

  • Number of participants with births <=48 hours from the first study treatment
    Timeframe: Up to 48 hours

  • Number of participants with births <=24 hours from the first study treatment
    Timeframe: Up to 24 hours

  • Number of maternal participants with non-serious adverse events (AEs) and serious adverse events (SAEs)
    Timeframe: Up to 6 weeks after delivery

  • Change from Baseline in diastolic blood pressure (DBP) and systolic blood pressure (SBP) in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in heart rate in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in respiratory rate in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in temperature in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets and leukocytes count in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in erythrocytes in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in hemoglobin and Erythrocyte Mean Corpuscular hemoglobin Concentration (MCHC) in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in erythrocyte mean corpuscular volume (MCV) and mean platelet volume (MPV) in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transferase (GGT) and lactate dehydrogenase (LDH) levels in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in albumin and protein levels in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in calcium, chloride, carbon dioxide, glucose, potassium, magnesium, phosphate and sodium level in maternal participants
    Timeframe: Baseline and up to 1 week

  • Change from Baseline in direct bilirubin, bilirubin, indirect bilirubin, creatinine and urate levels in maternal participants
    Timeframe: Baseline and up to 1 week

  • Number of maternal participants with AEs of special interest (AESI)
    Timeframe: Up to 6 weeks post-delivery

  • Number of maternal participants with disease related AEs (DRE)
    Timeframe: Up to 6 weeks post-delivery

  • Number of participants with fetal non-serious AEs and SAEs
    Timeframe: Up to 17 weeks

  • Number of participants with fetal AESI
    Timeframe: Up to 17 weeks

  • Neonatal APGAR Scores
    Timeframe: Up to 5 minutes after birth

  • Weight of neonates
    Timeframe: Up to 17 weeks

  • Head circumference of neonates
    Timeframe: Up to 17 weeks

  • Number of neonatal participants with non-serious AEs and SAEs
    Timeframe: Up to 28 days after the EDD of 40 weeks gestation

  • Number of neonatal participants with AESI
    Timeframe: Up to 28 days after EDD of 40 weeks gestation

  • Number of neonatal participants with DRE
    Timeframe: Up to 28 days after EDD of 40 weeks gestation

  • Maternal length of stay in hospital
    Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

  • Number of participants admitted to particular hospital unit
    Timeframe: Up to 28 days post EDD (40 0/7 weeks gestation)

  • Retosiban clearance
    Timeframe: Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

  • Volume of distribution of retosiban
    Timeframe: Day 1 (2 to 4 hours, 10 to 14 hours) and Day 2 (22 to 26 hours, and 48 to 54 hours) post-infusion

Arms:
  • 2

Interventions:

  • Drug: Retosiban
  • Drug: Atosiban
  • Drug: Placebo matching retosiban
  • Drug: Placebo matching atosiban

Keyword:

  • Spontaneous Preterm Labor, retosiban, GSK221149, atosiban
Inclusion / Exclusion Criteria: Click to view inclusion/exclusion criteria:
Enrollment: 97