NCT02326142

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2015

Geographic Reach
6 countries

23 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 25, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

November 6, 2017

Status Verified

November 1, 2017

Enrollment Period

1.6 years

First QC Date

December 22, 2014

Last Update Submit

November 3, 2017

Conditions

Preterm Labor

Keywords

Premature Obstetric LaborPremature Birth

Outcome Measures

Primary Outcomes (1)

  • EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose

    within 7 days of first dose

Secondary Outcomes (4)

  • EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose

    within 48 hours of first dose

  • EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks

    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

    up to 24 hours post first dose

  • EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)

    up to 7 weeks post first dose

Other Outcomes (4)

  • SAFETY ENDPOINTS: Evaluation of the maternal safety of OBE001 (Maternal incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs)

    up to 28 days post expected term date

  • SAFETY ENDPOINTS: Evaluation of the foetal safety of OBE001 (clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or Amniotic Fluid Indices (AFI)

    up to 14 days post first dose or birth whichever is earlier

  • SAFETY ENDPOINTS: Evaluation of the newborn neonatal morbidity

    up to 28 days post expected term date

  • +1 more other outcomes

Study Arms (2)

OBE001

EXPERIMENTAL
Drug: OBE001

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

OBE001DRUG

OBE001 dispersible tablets for a single oral dose a day for up to 7 days.

OBE001
PlaceboDRUG

Placebo dispersible tablets for a single oral dose a day for up to 7 days.

Placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age (GA) between 34\^0/7 and 35\^6/7 weeks.
  • Subjects with symptoms of preterm labour.
  • Subjects with a singleton pregnancy.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Liège, Belgium

Location

Unknown Facility

Bayreuth, Germany

Location

Unknown Facility

Düsseldorf, Germany

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Ulm, Germany

Location

Unknown Facility

Bialystok, Poland

Location

Unknown Facility

Chorzów, Poland

Location

Unknown Facility

Lodz, Poland

Location

Unknown Facility

Ruda Śląska, Poland

Location

Unknown Facility

Warsaw, Poland

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

El Palmar, Spain

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

Vitoria-Gasteiz, Spain

Location

Unknown Facility

Zaragoza, Spain

Location

Unknown Facility

Basel, Switzerland

Location

Unknown Facility

Bern, Switzerland

Location

Unknown Facility

Geneva, Switzerland

Location

Unknown Facility

Lausanne, Switzerland

Location

Unknown Facility

Leeds, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

MeSH Terms

Conditions

Obstetric Labor, PrematurePremature Birth

Interventions

OBE001

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 25, 2014

Study Start

March 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

November 6, 2017

Record last verified: 2017-11

Locations

DE(4)GB(2)ES(5)PL(5)BE(3)CH(4)