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

Trial Profile

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

Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Aug 2017

At a glance

  • Drugs Retosiban (Primary)
  • Indications Preterm labour
  • Focus Registrational; Therapeutic Use
  • Acronyms NEWBORN-1
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 11 Jul 2017 Planned End Date changed from 21 Nov 2019 to 21 Jul 2017.
    • 11 Jul 2017 Planned primary completion date changed from 21 Nov 2019 to 21 Jul 2017.
    • 14 Jun 2017 Planned End Date changed from 14 May 2019 to 21 Nov 2019.
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