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    The EU Clinical Trials Register currently displays   37220   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
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    EudraCT Number:2018-000283-28
    Sponsor's Protocol Code Number:64821
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-05-03
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-000283-28
    A.3Full title of the trial
    Potential effect of proton-pump inhibitor on angiogenic markers in preeclampsia: a pilot study
    Effect van protonpompremmers op angiogene markers in preeclampsie: een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of gastric reflux medication on biomarkers in toxemia of pregnancy
    Het effect van maagzuurremming op biomarkers bij vrouwen met zwangerschapsvergiftiging
    A.4.1Sponsor's protocol code number64821
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D. name Omeprazol
    D. of the Marketing Authorisation holderMylan B.V
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOmeprazol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Angiogenic markers in preeclampsia
    Angiogene markers in preeclampsie
    E.1.1.1Medical condition in easily understood language
    Biomarkers in toxemia of pregnancy
    Biomarkers in zwangerschapsvergiftiging
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate whether PPI administration (omeprazole) to women with confirmed PE significantly lowers circulating sFlt-1 levels
    Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), een significante daling veroorzaakt van de sFlt-1 waarde.
    E.2.2Secondary objectives of the trial
    1. Effects of PPI administration on circulating PlGF (elevation), sEndoglin (decrease), ET-1 (decrease) and CT-proET-1 (decrease) levels.
    2. Effects of PPI administration on cord blood sFlt-1, PlGF, sEndoglin, ET-1 and CT-proET-1 levels
    1. Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), effect heft op de angiogene markers; PlGF, sEng, ET-1 en CT-proET-1.
    2. Met dit onderzoek willen we bestuderen in hoeverre het gebruik van protonpompremmer (omeprazol), effect heft op de angiogene markers in navelstrengbloed; PlGF, sEng, ET-1 en CT-proET-1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women with (≥ 18 years) with a singleton pregnancy diagnosed with PE with a gestational age of ≥20 weeks and <34 weeks admitted to the obstetric department who give written informed consent, will be included.
    Vrouwen (≥ 18 jaar) met een eenlingzwangerschap en preeclampsie (zwangerschapsduur tussen ≥20 weken en <34 weken) opgenomen op de afdeling Verloskunde.
    E.4Principal exclusion criteria
    Multiple pregnancies
    Not willing to give written informed consent
    Other reasons than PE requiring hospitalization
    The use of PPI at time of randomization
    Contraindications or hypersensitivity to PPI use
    The use of medication affected by PPI
    Fetal death at time of inclusion
    Signs of fetal distress at time of inclusion
    Expected delivery ≤2 days
    Geen toestemming
    Andere opnameindicatie dan preeclampsie
    Contraindicatie of hypersensitiviteit voor PPI
    Het gebruik van medicatie dat invloed heeft op PPI
    Foetale dood
    Foetale nood ten tijde van inclusive
    Verwachte bevallingsdatum ≤2 dagen
    E.5 End points
    E.5.1Primary end point(s)
    The difference in sFlt-1 levels in women who have received PPI, in comparison to women who have not received PPI, at different time points.
    Het verschil in sFlt-1 waarde op verschillende tijdstippen tussen de interventie (PPI) en controlegroep
    E.5.1.1Timepoint(s) of evaluation of this end point
    After delivery evaluation of the primary outcome will take place
    Na de bevalling zal analyse van de primaire uitkomstmaat plaatsvinden
    E.5.2Secondary end point(s)
    1. The change in serum levels of PlGF, sEndoglin, ET-1 and CT-proET-1 levels between PPI and non-PPI group at different time points (before and after administration)
    2. The change in cord blood levels of sFlt-1, PlGF, sEndoglin, ET-1 and CT-proET-1 at time of delivery between PPI and non-PPI group.
    3. Blood pressure regulation and the need for blood pressure medication between PPI group and non-PPI group.
    4. Days until delivery between PPI group and non-PPI group.
    1. Het verschil in PlGF, sEndoglin, endothelin-1 (ET-1) en CT-proET-1 waarde tussen de interventie (PPI) en controlegroep.
    2. Het verschil in PlGF, sEndoglin, endothelin-1 (ET-1) en CT-proET-1 waarde tussen de interventie (PPI) en controlegroep in navelstrengbloed.
    3. Het verschil in bloeddrukregulatie en bloeddrukmedicatie gebruik tussen interventie (PPI) en controlegroep.
    4. Het aantal dagen tot de bevalling tussen de interventie (PPI) en controlegroep
    E.5.2.1Timepoint(s) of evaluation of this end point
    After delivery evaluation of the secondary outcome will take place.
    Na de bevalling zal analyse van de secundaire uitkomstmaat plaatsvinden.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    Geen PPI medicatie
    No PPI medication
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Laatste bevalling van laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 44
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Treatment with PPI will stop after delivery, and thus will be discontinued after the subject has ended participation
    Behandeling met PPI zal gestaakt worden na de bevalling, en dus zal de patiente na deelname van de studie deze niet meer gebruiken.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-05
    P. End of Trial
    P.End of Trial StatusOngoing
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