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    The EU Clinical Trials Register currently displays   39231   clinical trials with a EudraCT protocol, of which   6427   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:2007-003949-32
    Sponsor's Protocol Code Number:A6281287
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-11-26
    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 number2007-003949-32
    A.3Full title of the trial
    A two-year multi-centre, randomized two arm study of Genotropin treatment in very young children born small for gestational age: Early Growth and Neurodevelopment (EGN).

    ESTUDIO ALEATORIZADO, MULTICÉNTRICO, CON DOS GRUPOS Y DE DOS AÑOS DE DURACIÓN SOBRE EL TRATAMIENTO CON GENOTROPIN (GENOTONORM- MARCA REGISTRADA EN ESPAÑA) EN NIÑOS DE MUY CORTA EDAD NACIDOS PEQUEÑOS PARA SU EDAD GESTACIONAL: CRECIMIENTO Y NEURODESARROLLO TEMPRANOS (EGN).
    A.3.2Name or abbreviated title of the trial where available
    Not Applicable
    A.4.1Sponsor's protocol code numberA6281287
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberNot Applicable
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.2.1.1.1Trade name Genotonorm Kabipen 5.3 mg polvo y disolvente para solución inyectable (marca internacional Genotropin)
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacia Laboratories Ltd.
    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 nameGenotonorm Kabipen 5.3mg polvo y disolvente para solución inyectable(marca internacional Genotropin)
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSomatropin
    D.3.9.2Current sponsor codeGenotonorm Kabipen 5.3mg polvo y disolvente para solución inyectable(marca internacional Genotropin)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.035
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Short Stature children born small for Gestational Age (SGA).

    Niños de talla baja que nacieron pequeños para su edad gestacional (PEG).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10041093
    E.1.2Term Small for gestational age
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es evaluar la eficacia del tratamiento con Genotropin® sobre la PDE de la velocidad de aumento de la talla en niños PEG iniciando el tratamiento a una edad de 24 a 30 meses, en comparación con controles no tratados.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este ensayo son evaluar el efecto del tratamiento con Genotropin® sobre el desarrollo mental y psicomotor globales, el peso corporal, el índice de masa corporal (IMC), el crecimiento de la cabeza y la composición corporal, en comparación con controles no tratados, así como demostrar la seguridad del tratamiento con Genotropin® en niños PEG.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes deberán cumplir todos estos criterios de inclusión para poder participar en el estudio:
    1. Pacientes de ambos sexos, de raza blanca y de 19 a 29 meses de edad en la visita 1 de selección.
    2. Consentimiento informado firmado y fechado.
    3. Nacidos PEG (longitud y/o peso al nacer <-2 DE para la edad gestacional, utilizando los datos del país).
    4. Longitud inferior a -2,5 DE en la selección (19 a 29 meses de edad).
    5. Al menos una medición de la longitud entre los 12 y los 18 meses de edad.
    6. Cariotipo normal en las niñas, para descartar el síndrome de Turner.
    7. Valores de laboratorio normales en la selección, o con anomalías clínicamente insignificantes, según el investigador.

    E.4Principal exclusion criteria
    No se incluirá en el estudio a los sujetos que presenten alguno de los criterios siguientes:
    1. Intenso retraso del crecimiento intrauterino (IRCU) (longitud al nacer < -4 DE para la edad gestacional), si se asocia a características dismórficas.
    2. Prematurez intensa (edad gestacional (EG) < 32 semanas de gestación).
    3. En vías de alcanzar el crecimiento normal (definido por una PDE de la velocidad de crecimiento >0) basándose en un intervalo entre mediciones de 4 meses como mínimo.
    4. Estatura familiar muy baja, definida como: Talla del padre <155 cm o de la madre <145 cm.
    5. Defectos neurológicos definidos y/o retraso intenso del neurodesarrollo.
    6. Síndromes definidos, como la fetopatía alcohólica.
    7. Complicaciones perinatales intensas como asfixia, sepsis, enterocolitis necrotizante (ENC), síndrome de dificultad respiratoria, si se asocia a secuelas a largo plazo (como síndrome del intestino corto, displasia broncopulmonar (DBP), parálisis cerebral, etc.).
    8. Otras causas concretas de talla baja (p. ej., osteocondrodisplasia).
    9. Cualquier enfermedad intensa, aguda o crónica (neurológica, respiratoria, digestiva (p. ej., enfermedad celíaca)) que, en opinión del investigador, pueda interferir en la interpretación de las evaluaciones de la seguridad o de la eficacia.
    10. Pacientes con pocas probabilidades de cumplir el protocolo, p. ej., incapacidad de acudir a las visitas de seguimiento, o improbabilidad de que complete el estudio.
    11. Paciente que participa en otros estudios sobre productos experimentales o comercializados.
    12. Paciente que recibe tratamiento con glucocorticoides sistémicos en la actualidad o que lo ha recibido durante un período de una semana o más en los últimos 6 meses. Se autorizan los corticosteroides tópicos e inhalados.
    13. Los pacientes que reciban cualquier otro tratamiento hormonal no podrán participar en este estudio (salvo la terapia de sustitución de la hormona tiroidea estable).
    E.5 End points
    E.5.1Primary end point(s)
    Los análisis principales serán el de la variación de la PDE de la talla tras 24 meses de tratamiento y el la variación de la PDE de la velocidad de aumento de la talla a los 24 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 No
    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 EEA26
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Según protocolo
    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 days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    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
    El investigador deberá asegurarse de que todos los sujetos del estudio, o sus representantes legales, estén plenamente informados de la naturaleza y los objetivos del estudio y los posibles riesgos asociados a la participación.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 88
    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)
    Los pacientes continuarán con tratamiento comercial de acuerdo a las regulaciones locales hasta los 4 años de edad.
    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 Decision2007-12-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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