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

NCT02326142 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-11-06

No results posted yet for this study

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.

Conditions

  • Preterm Labor

Interventions

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.

Sponsors & Collaborators

  • ObsEva SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-10-31
Completion
2017-10-31

Countries

  • Belgium
  • Germany
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02326142 on ClinicalTrials.gov