Trial Profile

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

Status: Discontinued

Phase of Trial: Phase III

Latest Information Update: 04 Sep 2023

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At a glance

Drugs Retosiban (Primary)
Indications Preterm labour
Focus Registrational; Therapeutic Use
Acronyms NEWBORN-1
Sponsors GlaxoSmithKline; GSK

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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