A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A [retosiban] administered orally to healthy, pregnant females with uncomplicated pre-term labor between 30 0/7 and 35 6/7 weeks' gestation.

Trial Profile

A randomized, double-blind, placebo-controlled, dose ranging study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of GSK221149A administered intravenously and to investigate the pharmacokinetics of GSK221149A [retosiban] administered orally to healthy, pregnant females with uncomplicated pre-term labor between 30 0/7 and 35 6/7 weeks' gestation.

Completed
Phase of Trial: Phase II

Latest Information Update: 16 May 2017

At a glance

  • Drugs Retosiban (Primary) ; Retosiban (Primary)
  • Indications Preterm labour
  • Focus Adverse reactions; Proof of concept
  • Sponsors GlaxoSmithKline
  • Most Recent Events

    • 29 Jun 2012 Planned number of patients changed from 75 to 100 as reported by European Clinical Trials Database.
    • 14 Oct 2011 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 08 Apr 2011 Additional trial location (Colombia) identified, as reported by ClinicalTrials.gov
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