A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
NCT ID: NCT02326142
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
10 participants
INTERVENTIONAL
2015-03-31
2017-10-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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OBE001
OBE001
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
Placebo
Placebo
Placebo dispersible tablets for a single oral dose a day for up to 7 days.
Interventions
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OBE001
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
Placebo
Placebo dispersible tablets for a single oral dose a day for up to 7 days.
Eligibility Criteria
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Inclusion Criteria
* Subjects with symptoms of preterm labour.
* Subjects with a singleton pregnancy.
Exclusion Criteria
* 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.
18 Years
FEMALE
No
Sponsors
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ObsEva SA
INDUSTRY
Responsible Party
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Locations
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Brussels, , Belgium
Leuven, , Belgium
Liège, , Belgium
Bayreuth, , Germany
Düsseldorf, , Germany
Tübingen, , Germany
Ulm, , Germany
Bialystok, , Poland
Chorzów, , Poland
Lodz, , Poland
Ruda Śląska, , Poland
Warsaw, , Poland
Barcelona, , Spain
El Palmar, , Spain
Madrid, , Spain
Vitoria-Gasteiz, , Spain
Zaragoza, , Spain
Basel, , Switzerland
Bern, , Switzerland
Geneva, , Switzerland
Lausanne, , Switzerland
Leeds, , United Kingdom
London, , United Kingdom
Countries
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Other Identifiers
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14-OBE001-016
Identifier Type: -
Identifier Source: org_study_id