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    Summary
    EudraCT Number:2013-000013-20
    Sponsor's Protocol Code Number:NN8640-4042
    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:2014-01-10
    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 number2013-000013-20
    A.3Full title of the trial
    A randomised, open-labelled, active-controlled, multinational, dose-escalation trial investigating safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone (NNC0195-0092) compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency
    Ensayo multinacional de incremento escalonado de la dosis, aleatorizado, abierto y controlado con medicación activa sobre la seguridad, tolerabilidad, farmacocinética y farmacodinamia de una sola dosis de hormona del crecimiento de acción prolongada (NNC0195-0092) en comparación con la administración diaria de Norditropin® SimpleXx® en niños con carencia de hormona del crecimiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of long-acting growth hormone compared to daily dosing of Norditropin® SimpleXx® in children with growth hormone deficiency
    Ensayo para evaluar la seguridad,la tolerabilidad, farmacocinética y Farmacodinamia de una dosis única de hormona de crecimiento de acción prolongada en comparación con la administración diaria de Norditropin® SimpleXx® en niños con déficit de hormona del crecimiento.
    A.4.1Sponsor's protocol code numberNN8640-4042
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1138-2206
    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 SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 supportNovo Nordisk A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.6E-mailclinicaltrials@novonordisk.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 NNC0195-0092 DP 6.7 mg ml 3 ml cartridge
    D.3.4Pharmaceutical form Solution for injection in cartridge
    D.3.4.1Specific paediatric formulation No
    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 INNn/a
    D.3.9.1CAS number 1338578-34-9
    D.3.9.3Other descriptive nameNNC0195-0092
    D.3.9.4EV Substance CodeSUB32766
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.7
    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 Yes
    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 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 Norditropin SimpleXx 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovo Nordisk A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form Solution for injection in cartridge
    D.3.4.1Specific paediatric formulation No
    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.3.9.1CAS number 12629-01-5
    D.3.9.3Other descriptive nameSOMATROPIN
    D.3.9.4EV Substance CodeSUB10584MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.7
    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 Yes
    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
    Growth hormone deficiency in children
    Deficiencia de hormona de crecimiento en niños
    E.1.1.1Medical condition in easily understood language
    Growth hormone deficiency in children
    Deficiencia de hormona de crecimiento en niños
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate safety and tolerability of a single subcutaneous (s.c.) dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with growth hormone deficiency (GHD)
    Evaluar la seguridad y la tolerabilidad de una dosis subcutánea (s.c.) única de NNC0195 0092 en comparación con la administración diaria de Norditropin® SimpleXx® durante siete días en niños con déficit de hormona del crecimiento (GHD)
    E.2.2Secondary objectives of the trial
    - To evaluate pharmacokinetics (PK) and pharmacodynamics (PD) of a single s.c. dose of NNC0195-0092 in children with GHD
    - To evaluate local tolerability (i.e. injection site reactions) of a single s.c. dose of NNC0195-0092 compared to daily dosing of Norditropin® SimpleXx® for seven days in children with GHD
    Evaluar la farmacocinética (FC) y la farmacodinamia (FD) de una dosis s.c. única de NNC0195-0092 en niños con GHD
    Evaluar la tolerabilidad local (es decir, reacciones en el punto de inyección) de una dosis s.c. única de NNC0195-0092 en comparación con la administración diaria de Norditropin® SimpleXx® durante siete días en niños con GHD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Confirmed diagnosis of GHD as defined by two different GH stimulation tests, peak GH level ? 7.0 ng/mL. For children with three or more pituitary hormone deficiencies only one GH stimulation test will be needed. If in accordance with country specific practice growth hormone deficiency can be defined by only one GH stimulation test, peak GH level ? 7.0 ng/mL.
    - Pre-pubertal children at screening:
    - Boys: Tanner stage 1 and age ? 6 year and < 13 years
    - Girls: Tanner stage 1 and age ? 6 year and < 12 years
    - Body weight ?16.0 kg and ?50.0 kg
    - Stable GH replacement treatment ? 3 months
    Diagnóstico confirmado de GHD, según lo definido por dos pruebas de estimulación diferentes de la GH y una concentración máxima de GH ? 7,0 ng/ml.
    En los niños con déficit de tres o más hormonas hipofisarias, solo se necesitará una prueba de estimulación de la GH. Si con arreglo a la práctica específica del país, el déficit de hormona del crecimiento se puede definir solo mediante una prueba de estimulación de la GH y una concentración máxima de GH ? 7,0 ng/ml
    Niños prepúberes en la selección
    Niños: estadio 1 de Tanner y ? 6 años y < 13 años de edad
    Niñas: estadio 1 de Tanner y ? 6 años y < 12 años de edad
    Peso corporal ? 16,0 kg y ? 50,0 kg
    Tratamiento de sustitución estable con GH durante ? 3 meses
    E.4Principal exclusion criteria
    - History or presence of malignancy
    - Overt diabetes mellitus (fasting blood glucose ? 7.0 mmol/L)
    Antecedente o presencia de neoplasia maligna
    Diabetes mellitus manifiesta (glucemia en ayunas ? 7,0 mmol/l (126 mg/dl))
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events (AEs)
    Incidencia de acontecimiento adversos (AA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From first administration of trial product and up until day 35 (final visit)
    desde la primera administración del producto del ensayo hasta el día 35 (visita final)
    E.5.2Secondary end point(s)
    The area under the insulin-like growth factor I (IGF-I) concentration-time curve
    AUCde IGF-I (0-168 horas) Área bajo la curva de concentración-tiempo del factor de crecimiento insulinoide I (IGF-I)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From 0 to 168 hours after dosing
    desde 0 a 168 horas después de la administración
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Safety, pharmacokinetics, pharmacodynamics
    Seguridad, farmacocinéticas y farmacodinamias
    E.7.2Therapeutic exploratory (Phase II) No
    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 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 Yes
    E.8.1.7.1Other trial design description
    Escalada de dosis
    Dose escalation
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Norway
    European Union
    Israel
    Macedonia, the former Yugoslav Republic of
    Switzerland
    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
    LSLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months11
    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.1.1Number of subjects for this age range: 32
    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) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 29
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    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 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 32
    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)
    N/A
    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 Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-11-04
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