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    Summary
    EudraCT Number:2013-005336-23
    Sponsor's Protocol Code Number:Baby-OSCAR
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-06-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005336-23
    A.3Full title of the trial
    Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Baby-OSCAR (Baby Outcomes after Selective early targeted treatment for Closure of 'open' ductus ARteriosus in preterm babies)
    A.3.2Name or abbreviated title of the trial where available
    Baby-OSCAR Trial
    A.4.1Sponsor's protocol code numberBaby-OSCAR
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN84264977
    A.5.4Other Identifiers
    Name:REC NumberNumber:14/EM/0172
    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 Oxford
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR HTA
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oxford
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street AddressJoint Research Office, Block 60, Churchill Hospital
    B.5.3.2Town/ cityHeadington, Oxford
    B.5.3.3Post codeOX3 7LE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865 572221
    B.5.5Fax number01865572228
    B.5.6E-mailkarl.shepherd@admin.ox.ac.uk
    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 Yes
    D.2.5.1Orphan drug designation number10-29-1996
    D.3 Description of the IMP
    D.3.1Product nameNeoprofen (Ibuprofen lysine)
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNIbuprofen lysine
    D.3.9.1CAS number 57469-77-9
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mg/ml
    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.IMP: 2
    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.2.1.1.1Trade name Pedea
    D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe SARL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberORPHA131354
    D.3 Description of the IMP
    D.3.1Product namePedea (Ibuprofen)
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNIbuprofen
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg/ml
    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
    D.8 Placebo: 2
    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 the newborn
    E.1.1.1Medical condition in easily understood language
    PDA is a vessel which does not close and remains "patent" (open) resulting in irregular transmission of blood between 2 of the most important arteries in the heart, the aorta and the pulmonary artery.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 determine if the selective treatment of confirmed large PDAs in extremely preterm babies with ibuprofen within 72 hours of birth reduces the incidence of death or bronchopulmonary dysplasia (BPD) at 36 weeks' post-menstrual age.

    To find this out babies who are eligible to take part in the study will be given either ibuprofen (a drug which is approved for the treatment of PDA in premature babies), or placebo (salt water). Researchers will then record the number of babies that develop a condition called Bronchopulmonary Dysplasia (BPD) which is a known complication of PDA and baby deaths by a defined time point, to determine if there is any difference between the babies given ibuprofen and those given placebo.
    E.2.2Secondary objectives of the trial
    The other aims of the study are to find out if there is any difference in the health and welfare between babies given ibuprofen and those given placebo both in the short term (while the baby is still in hospital) and also in the longer term (when the baby is 2 years of age, calculated from their due date).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Babies will be considered eligible for inclusion into the study if they are;
    • Born at 23+0 to 28+6 weeks of gestation
    • Less than 72 hours old
    • Confirmed by echocardiography to have a large PDA which
    o Is ≥ 1.5 mm in diameter (determined by gain optimised colour Doppler)
    o Has unrestrictive pulsatile left to right flow
    In addition:
    The responsible clinician is uncertain about whether this baby might benefit from treatment to close the PDA
    Written informed consent has been obtained from the parent(s)
    E.4Principal exclusion criteria
    Babies will be excluded from participation in the study if they have;
    • No realistic prospect of survival
    • Severe congenital anomaly
    • Structural heart disease requiring treatment
    • Other conditions that would contraindicate the use of ibuprofen (intracranial or gastrointestinal haemorrhage, coagulopathy, thrombocytopenia (platelet count <50,000), renal failure, pulmonary hypertension, known or suspected necrotising enterocolitis)
    • Antenatal treatment with a COX inhibitors
    • Received indomethacin, ibuprofen or paracetamol after birth.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome for the study is to determine if selective treatment of confirmed large Patent Ductus Arteriosus in extremely preterm babies with ibuprofen, within 72 hours of birth, reduces the incidence of death or Bronchopulmonary Dysplasia at 36 weeks post-menstrual age.
    E.5.1.1Timepoint(s) of evaluation of this end point
    36 week's postmenstrual age
    E.5.2Secondary end point(s)
    Secondary Short Term Endpoints:
    •Death before discharge
    Incidence or duration of the following up to discharge from NNU:
    •Severity of BPD at 36 weeks of postmenstrual age
    •Severe IVH (grade 3/4 with ventricular dilation or intraparenchymal bleeding)
    •Cystic PVL
    •ROP requiring treatment
    •Pulmonary haemorrhage
    •Pulmonary hypertension
    •NEC definitive and/or complicated (Bell stage II and above) confirmed by
    radiography or histopathology
    •NEC requiring surgery
    •Gastrointestinal bleeding within 7 days of the first dose of trial drug
    administration
    •Spontaneous intestinal perforation
    •PDA closure at 3 weeks of age (or hospital discharge if discharged before
    this age)
    •Medical rescue treatment with a COX inhibitor/surgical treatment of a symptomatic PDA
    •Administration and duration of inotropic support
    •Duration of mechanical ventilation
    •Total duration of respiratory support (ventilation + nCPAP/high flow oxygen
    therapy)
    •Discharge home on oxygen
    •Duration of initial hospitalisation (birth to NNU discharge)
    •Postnatal steroid use
    •Safety and tolerability of ibuprofen treatment
    •Number of doses of trial medication received during intervention period

    Secondary Long Term Endpoints (at 2 years of age, corrected for prematurity)
    •Survival without moderate or severe neurodevelopment disability
    •Individual components of survival without moderate or severe disability (in
    the four domains of motor, cognitive, hearing and visual function)
    •Survival without respiratory morbidity

    A cost-effectiveness analysis will be conducted of death and BPD events avoided and national health services used up to 2 years of age corrected for prematurity.

    Secondary Long Term Endpoints (at primary school)
    •Neurological and developmental outcomes (separate funding may be applied for depending on the results of the trial).
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 36 Weeks Postmenstrual Age
    - Discharge
    - Infant, 2 Years Corrected Age
    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 No
    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.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 concerned4
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days31
    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: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 730
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state730
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 730
    F.4.2.2In the whole clinical trial 730
    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)
    Administration of study medication will be completed 48 hours after the first dose is given. Participants will however be involved in the study up until they are 2 years of age, corrected for prematurity, to assess long term outcomes.

    Open pharmacological treatment of PDA after completion of study medication administration, or if indicated before, is permitted based on clinical and echocardiographic criteria. The supply of medication for open PDA treatment would be in accordance with NHS
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Thames Valley CLRN
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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