Preterm LaborPhase 2TERMNCT02326142
A Phase 2 Study of OBE001 Versus Placebo in the Delay of Preterm Birth
A Phase 2 study testing OBE001 in people with Preterm Labor, run by ObsEva SA at 23 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Labor
- What is being tested?
- OBE001
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 23 sitesin 6 countries
- Study dates
- Mar 2015to Oct 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Gestational age (GA) between 34^0/7 and 35^6/7 weeks.
- Subjects with symptoms of preterm labour.
- Subjects with a singleton pregnancy.
Who cannot join
- 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.
Trial locations and contacts
23 sites in 6 countries.
23 sites in 6 countries
Poland5 sites
Study site
Bialystok
Study site
Chorzów
Study site
Lodz
Study site
Ruda Śląska
Study site
Warsaw
Spain5 sites
Study site
Barcelona
Study site
El Palmar
Study site
Madrid
Study site
Vitoria-Gasteiz
Study site
Zaragoza
Germany4 sites
Study site
Bayreuth
Study site
Düsseldorf
Study site
Tübingen
Study site
Ulm
Switzerland4 sites
Study site
Basel
Study site
Bern
Study site
Geneva
Study site
Lausanne
About this study
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.
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.
Read the detailed 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.
- Conditions
- Preterm Labor
- Being tested
- OBE001, Placebo
- Keywords
- Premature Obstetric Labor, Premature Birth
- Medical subject headings
- Obstetric Labor, Premature, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBE001Drug
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
PlaceboDrug
Placebo dispersible tablets for a single oral dose a day for up to 7 days.
| Study group | Role | What they receive |
|---|---|---|
| OBE001 | Experimental | Not described Receives: Drug: OBE001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
Measured: within 7 days of first dose
Secondary outcomes (4)
EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose
Measured: within 48 hours of first dose
EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks
Measured: 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
Contractions measured by tocodynamometry.
Measured: up to 24 hours post first dose
EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001)
Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose) on Day 3 (pre-dose), Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery.
Measured: up to 7 weeks post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionOct 2016
- Study completionOct 2017
Why it stopped: Enrolment difficulties.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm LaborStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ObsEva SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326142
- Sponsor's protocol ID
- 14-OBE001-016
- Acronym
- TERM
- Status last verified
- Nov 2017
- First submitted
- 22 Dec 2014
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02326142
- Acronym / sponsor ID
- TERM / 14-OBE001-016
- Conditions
- Preterm Labor
- Keywords
- Premature Obstetric Labor, Premature Birth
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolment difficulties.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ObsEva SAIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OBE001 | Experimental | Drug: OBE001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age (GA) between 34^0/7 and 35^6/7 weeks.
- Subjects with symptoms of preterm labour.
- Subjects with a singleton pregnancy.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OBE001OBE001 dispersible tablets for a single oral dose a day for up to 7 days. | Drug | OBE001 |
| PlaceboPlacebo dispersible tablets for a single oral dose a day for up to 7 days. | Drug | Placebo |
Primary outcome
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose
Time frame: within 7 days of first dose
4 secondary outcomes
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
Results and safety
The study was stopped early (reason given: Enrolment difficulties.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing OBE001 in people with Preterm Labor, run by ObsEva SA at 23 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Poland, Spain, Germany, Switzerland, Belgium and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolment difficulties.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose (time frame: within 7 days of first dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.