A phase 2 study of OBE001 versus placebo in the delay of preterm birth
Research type
Research Study
Full 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.
IRAS ID
164991
Contact name
Phillip Bennett
Contact email
Sponsor organisation
ObsEva SA
Eudract number
2014-003217-28
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Preterm delivery defined as delivery before completion of week 37 of gestation is the major cause of perinatal mortality in the developed world. Currently, preterm birth remains a leading cause of infant mortality and morbidity, and due to standard treatments lacking uterine selectivity (that can also cause potentially serious side effects both for the mother and the fetus), there is an urgent need to develop drugs that would allow long lasting inhibition of labour and prolong pregnancy.
The study drug, OBE001, is an experimental medicine which means it has not been approved by the drug approval agency. This study is designed to determine whether OBE001 daily for seven days can delay preterm birth in women with threatened preterm labour. It is an exploratory study with a sample size based on some initial assumptions about the possible effect size.
This study will have one treatment period of up to 7 days, where participants will be randomised (like flipping a coin) in a 1:1 ratio to receive Placebo (does not contain any active medicine) or OBE001, to be taken orally. A placebo control has been chosen as the most appropriate comparator as potential active comparators are either not approved for this indication and/or have limited efficacy and are restricted to 48 hour use.
About 100 participants will be in the study across Europe, and they will be in the study for up to 77 days.REC name
London - West London & GTAC Research Ethics Committee
REC reference
14/LO/2196
Date of REC Opinion
30 Jan 2015
REC opinion
Further Information Favourable Opinion