Overview

This trial is active, not recruiting.

Condition preterm labor
Treatments obe001, placebo
Phase phase 2
Sponsor ObsEva SA
Start date March 2015
End date August 2016
Trial size 10 participants
Trial identifier NCT02326142, 14-OBE001-016

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
obe001
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
(Placebo Comparator)
placebo
Placebo dispersible tablets for a single oral dose a day for up to 7 days.

Primary Outcomes

Measure
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
time frame: within 7 days of first dose

Secondary Outcomes

Measure
EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose
time frame: within 48 hours of first dose
EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks
time frame: up to 3 weeks post first dose
EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose
time frame: up to 24 hours post first dose
EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)
time frame: up to 7 weeks post first dose

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Gestational age (GA) between 34^0/7 and 35^6/7 weeks. - Subjects with symptoms of preterm labour. - Subjects with a singleton pregnancy. Exclusion Criteria: - Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy. - Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery. - Use of cervical cerclage or a pessary in situ in the current pregnancy. - The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.

Additional Information

Official title 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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by ObsEva SA.