A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour

Trial Profile

A phase 2a, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the efficacy, safety and pharmacokinetics of OBE022 added-on to atosiban, after oral administration in pregnant women with threatened spontaneous preterm labour

Recruiting
Phase of Trial: Phase II

Latest Information Update: 05 Dec 2017

At a glance

  • Drugs OBE 022 (Primary)
  • Indications Preterm labour
  • Focus Adverse reactions; Pharmacodynamics; Pharmacokinetics; Proof of concept; Therapeutic Use
  • Acronyms PROLONG
  • Sponsors ObsEva
  • Most Recent Events

    • 05 Dec 2017 According to an ObsEva media release, part A of the trial is being conducted in Finland at the Helsinki University Women's Hospital, under the supervision of Professor Seppo Heinonen, the Director of Obstetrics and Gynaecology. The company expects to announce preliminary results from 60 patients in Part B in late 2018.
    • 04 Nov 2017 Status changed from planning to recruiting.
    • 15 Aug 2017 According to an ObsEva media release, commencement of this trial is expected in the fourth quarter of 2017, with top-line data release expected around year end 2018.
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