GSK-200719

Study Sponsor: GSK

Study Title

Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor

Medicine or Vaccine (generic name)

retosiban

Sponsor Identification Number

200719

Trial Registry Identification Number(#'s)

NCT02377466 2014-003326-41

Medical Condition

Obstetric Labour, Premature

Phase

Phase 3

Link to study details on the GSK Clinical Study Register

https://www.gsk-studyregister.com/en/trial-details/?id=200719

Link to study details on ClinicalTrials.gov (if available)

http://clinicaltrials.gov/show/NCT02377466

Link to study details on EudraCT (if available)

https://www.clinicaltrialsregister.eu/ctr-search/search?query=/2014-003326-41

Datasets and Documents Available for this Study

Raw dataset	Annotated case report form	Dataset specifications	Protocol with any amendments
Analysis-ready dataset	Reporting and analysis plan	Clinical study report	Ready to Share

Additional information about the data and documents available for this study

The data for this study is available in CDISC format.

Date Added to this Site

June 2020