NCT02326142

A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth

A Phase 2, Double-blind, Parallel Group, Randomised, Placebo Controlled, Proof of Concept Study to Assess the Safety and Efficacy of OBE001 After Oral Administration in Pregnant Women With Threatened Preterm Labour.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: ObsEva SA · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.

Detailed description

The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34\^0/7 and 35\^6/7 weeks of gestation. The study will be in 2 parts as follows: * from screening until the day of delivery (including a treatment period up to seven days) * a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later). In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.

Conditions

• Preterm Labor

Interventions

Type	Name	Description
DRUG	OBE001	OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
DRUG	Placebo	Placebo dispersible tablets for a single oral dose a day for up to 7 days.

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-10-01
• Completion: 2017-10-01
• First posted: 2014-12-25
• Last updated: 2017-11-06

Locations

23 sites across 6 countries: Belgium, Germany, Poland, Spain, Switzerland, United Kingdom