Clinical Trial Page

Summary
EudraCT Number:2017-001376-28
Sponsor's Protocol Code Number:NL57885.091.16
National Competent Authority:Belgium - FPS Health-DGM
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2018-02-13
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
A. Protocol Information
A.1Member State ConcernedBelgium - FPS Health-DGM
A.2EudraCT number2017-001376-28
A.3Full title of the trial
Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants.
Multicenter, gerandomiseerde 'non-inferiority' studie van een vroege behandeling versus een expectatief beleid bij een persisterende ductus arteriosus bij te vroeg geborenen.
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Study to investigate the optimal treatment of a patent ductus arteriosus (Botalli) in preterm newborn infants.
Onderzoek naar een optimale behandeling van een open ductus arteriosus (Botalli) bij te vroeg geboren kinderen.
A.3.2Name or abbreviated title of the trial where available
BeNeDuctus Trial
BeNeDuctus Studie
A.4.1Sponsor's protocol code numberNL57885.091.16
A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02884219
A.5.4Other Identifiers
Name:Netherlands Trial RegisterNumber:NTR5479
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 SponsorRadboud University Medical Center
B.1.3.4CountryNetherlands
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 supportNWO - The Netherlands Organization for Health Research & Development
B.4.2CountryNetherlands
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationRadboud University Medical Center
B.5.2Functional name of contact pointProject leader
B.5.3 Address:
B.5.3.1Street AddressGeert Grooteplein Zuid 10
B.5.3.2Town/ cityNijmegen
B.5.3.3Post code6525GA
B.5.3.4CountryNetherlands
B.5.6E-mailwillem.deboode@radboudumc.nl
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleComparator
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 Ibuprofen - Pedea 5 mg/ml solution for injection
D.2.1.1.2Name of the Marketing Authorisation holderOrphan Europe S.A.R.L.
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 numberEU/1/04/284
D.3 Description of the IMP
D.3.4Pharmaceutical form Concentrate and solvent for solution for 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.3.9.1CAS number 57469-77-9
D.3.9.2Current sponsor code-
D.3.9.3Other descriptive namePedea 5 mg/ml solution for injection
D.3.9.4EV Substance CodeSUB08098MIG
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number5
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
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Patent ductus arteriosus in the preterm infant
E.1.1.1Medical condition in easily understood language
Patent ductus arteriosus in the preterm infant
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 Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
To investigate whether in preterm infants, born at a GA less than 28 completed weeks, with a PDA (diameter >1.5 mm) an expectative management is not inferior to early treatment with regard to the composite of mortality and/or NEC (Bell stage ≧ IIa) and/or BPD at a PMA of 36 weeks.
E.2.2Secondary objectives of the trial
Not applicable
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Gestational age < 28 completed weeks
- Postnatal age < 72 hours
- PDA diameter > 1.5 mm and ductal (predominantly) left-to-right shunt
- Signed informed consent obtained from parent(s) or representative(s)
E.4Principal exclusion criteria
- Contraindication for administration of cyclooxygenase-inhibitors (COXi)
- Use of COXi prior to randomization
- Persistent pulmonary hypertension (ductal right-to-left shunt ≧33% of cardiac cycle)
- Congenital heart defect, other than PDA and/or PFO
- Life-threatening congenital defects
- Chromosomal abnormalities and/or congenital anomalies associated with abnormal neurodevelopmental outcome
E.5 End points
E.5.1Primary end point(s)
The primary endpoint is the composite of:
- Mortality at a postmenstrual age of ≤ 36 completed weeks, and/or
- NEC (Bell stage ≥ IIa) at a postmenstrual age of ≤ 36 completed weeks, and/or
- BPD, defined as the need for supplemental oxygen need at a postmenstrual age of 36 completed weeks
E.5.1.1Timepoint(s) of evaluation of this end point
Postmenstrual age of 36 completed weeks
E.5.2Secondary end point(s)
Secondary endpoints are short term sequela of cardiovascular failure, adverse effects during the stay in the hospital and long term neurodevelopmental consequences assessed at a corrected age of 2 years.
E.5.2.1Timepoint(s) of evaluation of this end point
- During the stay in hospital
- At a corrected age of 24 months
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) 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.8.2.3.1Comparator description
Expectative management ("watchful waiting")
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 concerned10
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA18
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 years4
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years4
E.8.9.2In all countries concerned by the trial months0
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: 564
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: 564
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 No
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
Preterm infants on a neonatal intensive care unit. Informed consent is obtained from parents or representatives
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state450
F.4.2 For a multinational trial
F.4.2.1In the EEA 564
F.4.2.2In the whole clinical trial 564
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)
All preterm infants will be checked as part of the standard of care in the follow-up program.
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 Netherlands Neonatal Research Network
G.4.3.4Network Country Netherlands
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2018-03-22
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2018-05-15
P. End of Trial
P.End of Trial StatusOngoing

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