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    Summary
    EudraCT Number:2018-000565-36
    Sponsor's Protocol Code Number:38/2018
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2018-000565-36
    A.3Full title of the trial
    Paracetamol and ibuprofen/indomethacin in closing persistent ductus arteriosus
    Parasetamolin ja ibuprofeenin/indometasiinin yhteisvaikutus pienen keskosen avoimen duktuksen hoidossa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Paracetamol and ibuprofen/indomethacin in closing persistent ductus arteriosus
    Parasetamolin ja ibuprofeenin/indometasiinin yhteisvaikutus pienen keskosen avoimen valtimotiehyen hoidossa
    A.3.2Name or abbreviated title of the trial where available
    The PAI study
    PAI
    A.4.1Sponsor's protocol code number38/2018
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03648437
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Oulu
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFoundation for Pediatrics Research
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportAlma och K.A. Snellman Foundation
    B.4.2CountryFinland
    B.4.1Name of organisation providing supportTerttu Foundation
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu University Hospital
    B.5.2Functional name of contact pointDepartment of Pediatrics
    B.5.3 Address:
    B.5.3.1Street AddressPOB 23
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90029 OYS
    B.5.3.4CountryFinland
    B.5.4Telephone number+358 83155810
    B.5.6E-mailouti.aikio@ppshp.fi
    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 No
    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 nameParacetamol Kabi Pharmacia 10 mg/ml
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNParacetamol
    D.3.9.3Other descriptive namePARACETAMOL
    D.3.9.4EV Substance CodeSUB09611MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patent ductus arteriosus of a premature infant
    Avoin valtimotiehyt
    E.1.1.1Medical condition in easily understood language
    Patent ductus arteriosus of a premature infant
    Avoin valtimotiehyt
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    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 the effect and safety of intravenous paracetamol when combining with ibuprofen/indomethacin therapy for patent ductus arteriosus
    Tämän tutkimuksen tarkoituksena on selvittää parasetamolin ja ibuprofeenin/indometasiinin yhteisvaikutusta ja turvallisuutta avoimen duktuksen sulkemisessa pienillä keskosilla.
    E.2.2Secondary objectives of the trial
    Not applicapple
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - premature infants
    - treated in the neonatal intensive care units of the attending sites
    - diagnosed to have a hemodynamically significant patent ductus arteriosus
    - intravenous ibuprofen or indomethacin medication
    Tutkimukseen otetaan mukaan tutkimuskeskusten vastasyntyneiden teho-osastoilla hoidettavia keskosia, joille aloitetaan hoitavan lääkärin päätöksellä hemodynaamisesti merkitsevän valtimiotiehyen vuoksi suonensisäinen ibuprofeeni- tai indometsiinihoito.
    E.4Principal exclusion criteria
    - no parental consent
    - any congenital or chromosomal anomaly or severe clinical situation that complicates the conventional ductal therapy, e.g. severe asphyxia or persistent pulmonary hypertension of a newborn
    Tutkimuksen poissulkukriteereitä ovat vanhempien kieltäytyminen, vaikea rakenne- tai kromosomipoikkeavuus tai muu vaikea kliininen tilanne, joka vaikeuttaa olennaisesti pienen keskosen tavanomaista duktushoitoa, esimerkiksi vaikea asfyksia tai koholla oleva keuhkoverenpaine (PPHN). Sydämen ultraäänitutkimuksessa potilaalla voi olla alle 3 mm kokoinen kammioväliseinäaukko, mutta tätä vaikeammat sydämen rakennepoikkeavuudet ovat poissulkukriteereitä.
    E.5 End points
    E.5.1Primary end point(s)
    Ductal closure
    Duktuksen sulkeutuminen
    E.5.1.1Timepoint(s) of evaluation of this end point
    - after the study drug period
    - discharge from neonatal intensive care unit
    - tutkimuslääkkeen jälkeen
    - poistuessa vastasyntyneiden teholta
    E.5.2Secondary end point(s)
    - further ductal therapies
    - neonatal morbidity and mortality: IVH, NEC, BPD, ROP
    - muut duktushoidot
    - myöhäisempi vastasyntyneen sairastavuus ja kuolleisuus
    E.5.2.1Timepoint(s) of evaluation of this end point
    - discharge from hospital
    - kotiuminen
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 Yes
    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
    LVLS
    Viimeisen potilaan kotiutuminen
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 60
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 60
    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) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Premature infants
    Keskoset
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    None
    Ei mitään
    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 Decision2018-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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