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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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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    Summary
    EudraCT Number:2014-002624-28
    Sponsor's Protocol Code Number:FIT-EU-04
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-08-20
    Trial results View 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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-002624-28
    A.3Full title of the trial
    A Multi-center, Double-blind, Randomized Placebo Controlled Study to Assess the Efficacy and Safety of NTRA-2112 on Gastrointestinal Maturation in Preterm Infants.
    Estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la eficacia y la seguridad de NTRA 2112 en la maduración digestiva de los recién nacidos prematuros.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Assess the Efficacy and Safety of NTRA-2112 on Gastrointestinal Maturation in Preterm Infants.
    Estudio para evaluar la eficacia y la seguridad de NTRA-2112 en la maduración gastrointestinal en bebés prematuros.
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberFIT-EU-04
    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 SponsorNutrinia Ltd.
    B.1.3.4CountryIsrael
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNutrinia Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSAIL SLL
    B.5.2Functional name of contact pointPunto de Información
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Meridiana 350, 9D
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08027
    B.5.3.4CountrySpain
    B.5.4Telephone number34935042736
    B.5.5Fax number34935042736
    B.5.6E-mailinfo@sail-biometria.com
    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.3.2Product code NTRA-2112
    D.3.4Pharmaceutical form Oral powder in sachet
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINSULIN HUMAN
    D.3.9.1CAS number 11061-68-0
    D.3.9.2Current sponsor codeNTRA-2112
    D.3.9.4EV Substance CodeSUB08197MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboOral powder in sachet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastrointestinal Maturation in Preterm Infants.
    Maduración gastrointestinal en bebés prematuros.
    E.1.1.1Medical condition in easily understood language
    Preterm infants have an under-developed gastrointestinal tract.
    The final Insulin concentration obtained with NTRA-2112 is physiological and within the range present in human breast milk.
    Los bebés prematuros tienen un aparato digestivo subdesarrollado.
    La concentración de insulina final obtenido con NTRA-2112 es muy parecida y está dentro del rango presente en la leche materna humana.
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    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 assess the efficacy of NTRA-2112 on gastrointestinal maturation by the time required to reach full enteral feeding in preterm infants during the treatment period as compared to a Placebo formulation.
    Evaluar el efecto de NTRA 2112 en función del número de días para alcanzar las condiciones para el alta hospitalaria (en función de criterios definidos previamente) en comparación con la formulación de placebo.
    E.2.2Secondary objectives of the trial
    -To assess the effect of NTRA-2112 on number of days to achieve readiness to discharge (based on predefined criteria) from the hospital as compared to Placebo formulation.
    -To assess the effect of NTRA-2112 on the number of days to end gastric residuals over 3 ml during the treatment period as compared to Placebo formulation.
    -To assess the effect of NTRA-2112 on growth by assessing: the weight gain ,body length and head circumference in the preterm infants as compared to Placebo formulation
    - To assess the safety of NTRA-2112 for preterm infants as compared to Placebo formulation
    -Evaluar el efecto de NTRA-2112 en función del número de días necesarios para alcanzar las condiciones para el alta hospitalaria en comparación con la formulación de placebo.
    -Evaluar el efecto de NTRA-2112 en función del número de días necesarios para eliminar residuos gástricos superiores a 3 ml durante el período de tratamiento en comparación con la formulación de placebo.
    -Evaluar el efecto de NTRA-2112 en parámetros de crecimiento en comparación con la formulación de placebo.
    -Evaluar la seguridad de NTRA-2112 en los recién nacidos prematuros en comparación con la formulación de placebo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female pre-term infants 26-32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and early antenatal ultrasound (no intra-uterine retardation).
    2. Birth weight ? 500 gr.
    3. Postnatal age up to 5 days.
    4. Fraction of inspired oxygen ? 0.60 at enrollment.
    5. The infant is in a cardiovascular stable condition.
    6. No heart and chest compression or any resuscitation drugs given to the infant during delivery.
    7. Informed consent form signed by parents or legal guardian.
    8. In the Investigator?s opinion, is able to comply with the trial requirements.
    1. Recién nacidos prematuros de 26-32 semanas de gestación. Edad gestacional situada (±2 semanas) entre las fechas maternas y la ecografía previa al nacimiento (sin retardo intrauterino).
    2. Peso al nacer ? 500 gr.
    3. Edad postnatal máxima de 5 días.
    4. Fracción inspirada de oxígeno ? 0,60 en la inclusión.
    5. El neonato presenta estabilidad cardiovascular.
    6. No se ha administrado compresión coronaria o torácica o fármacos de reanimación al neonato durante el parto.
    7. Documento de consentimiento informado firmado por los padres o el tutor legal.
    8. En opinión del investigador, es capaz de cumplir los requisitos del estudio.
    E.4Principal exclusion criteria
    1. Pre-term infants age > 32 weeks or < 26 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and early antenatal ultrasound.
    2. Birth weight < 500 gr.
    3. Postnatal age > 5 days
    4. Fraction of inspired oxygen > 0.60 at enrollment.
    5. The infant is in cardiovascular instability.
    6. Complete enteral feeding.
    7. Major congenital malformation ? Infants with genetic metabolic or endocrine disorder diagnosed before enrollment (including disorders diagnosed after enrollment but are known to be congenital).
    8. High index of suspicion of infection before enrollment.
    9. Confirmed NEC.
    10. Maternal diabetes.
    11. The infant is treated with Insulin.
    12. NPO, nothing per os for any reason at the study entry.
    13. Heart and chest compression or any resuscitation drugs given to the infant during delivery.
    14. Participation in another clinical study.
    15. In the Investigator?s opinion, is not able to comply with the trial requirements.
    1. Recién nacidos prematuros con una edad de > 32 semanas o < 26 semanas de gestación. Edad gestacional situada (±2 semanas) entre las fechas maternas y la ecografía previa al nacimiento.
    2. Peso al nacer < 500 gramos.
    3. Edad postnatal > 5 días.
    4. Fracción inspirada de oxígeno > 0,60 en la inclusión.
    5. El neonato presenta inestabilidad cardiovascular.
    6. Nutrición enteral completa.
    7. Malformación congénita grave: neonatos con trastornos metabólicos o endocrinos genéticos diagnosticados antes de la inclusión (incluidos los trastornos diagnosticados después de la inclusión pero que se sabe que son congénitos).
    8. Alto índice de sospecha de infección antes de la inclusión.
    9. NEC confirmada.
    10. Diabetes materna.
    11. El neonato está siendo tratado con insulina.
    12. NPO, ausencia de ingesta por vía oral por cualquier motivo en el momento de la inclusión en el estudio.
    13. Se han administrado compresión coronaria o torácica o fármacos de reanimación al neonato durante el parto.
    14. Participación en otro estudio clínico.
    15. En opinión del investigador, no es capaz de cumplir los requisitos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of days to achieve complete enteral feeding (NFE) defined by:
    Number of Days to achieve enteral feeding of 150 cc/kg/day for at least 3 consecutive days
    Note that the NFE will be computed until the first of the three consecutive days.
    Número de días para alcanzar la alimentación enteral completa definidos por:
    Número de días para alcanzar la alimentación enteral de 150 cc/kg/día durante al menos 3 días consecutivos

    Tenga en cuenta que la alimentación enteral completa se calcula hasta alcanzar el primero de los tres días consecutivos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 28 days
    Hasta 28 días
    E.5.2Secondary end point(s)
    Number of Day to Readiness-for-Discharge (NRD), defined by meeting all the criteria enumerated below:
    1. Infant weight ? 1800 g
    2. Stable body temperature
    Readiness for oral feeding
    Número de días en alcanzar las condiciones para el alta, definidas como:
    1. Peso del neonato ≥ 1800 gr.
    2. Temperatura corporal estable.
    3. Capacidad para recibir alimentación por vía oral.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 3 months
    Hasta 3 meses
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 Yes
    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 concerned6
    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
    The newborn will be brought for a follow-up visit at the age of 3 months (±7 days). Upon parents? approval (parents will be asked to sign a new ICF), the infants will be enrolled for a follow up extension study up to 2Y from the infant's birth.
    In case the parents withdraw their consent, the infant?s participation in the study will be terminated.
    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
    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: 250
    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: 250
    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.1.2.1Number 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 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
    Babies
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state250
    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)
    The newborn will be brought for a follow-up visit at the age of 3 months (±7 days). Upon parents? approval (parents will be asked to sign a new ICF), the infants will be enrolled for a follow up extension study up to 2Y from the infant's birth.
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-10-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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