98
Participants
Start Date
June 1, 2015
Primary Completion Date
September 2, 2019
Study Completion Date
September 2, 2019
Retosiban
This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Atosiban
This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
Placebo
This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
GSK Investigational Site, Ghent
GSK Investigational Site, Safed
GSK Investigational Site, Monza
GSK Investigational Site, Haifa
GSK Investigational Site, Hadera
GSK Investigational Site, Kfar Saba
GSK Investigational Site, Guadalajara
GSK Investigational Site, Petah Tikva
GSK Investigational Site, Zaragoza
GSK Investigational Site, Siena
GSK Investigational Site, Holon
GSK Investigational Site, Park Ridge
GSK Investigational Site, Tel Aviv
GSK Investigational Site, Monterrey
GSK Investigational Site, Freiburg im Breisgau
GSK Investigational Site, Ciudad Obregón
GSK Investigational Site, Galveston
GSK Investigational Site, Jena
GSK Investigational Site, Miyagi
GSK Investigational Site, Miyazaki
GSK Investigational Site, Seongnam
GSK Investigational Site, Seoul
GSK Investigational Site, Seoul
GSK Investigational Site, Uppsala
GSK Investigational Site, Sunderland
GSK Investigational Site, London
Lead Sponsor
Collaborators (1)
PPD Development, LP
INDUSTRY
GlaxoSmithKline
INDUSTRY