Trial Profile

Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 29 Jul 2023

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At a glance

Drugs Retosiban (Primary) ; Atosiban
Indications Preterm labour
Focus Adverse reactions; Registrational
Acronyms ARIOS; ARIOS Follow-up Study
Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development

Most Recent Events

01 Jul 2023 Results reporting adverse outcome or impairment with retosiban based on safety monitoring and neurodevelopment assessments published in the American Journal of Perinatology
14 Sep 2019 Status changed from active, no longer recruiting to completed.
11 Jun 2019 Planned End Date changed from 29 Jul 2022 to 28 Jul 2019.

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