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    Summary
    EudraCT Number:2021-001069-20
    Sponsor's Protocol Code Number:HIDROGUM21
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-12
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-001069-20
    A.3Full title of the trial
    Tolerability and acceptance of two oral hydrocortisone compounding formulation for pediatrics
    Estudio de tolerabilidad y aceptación de dos fórmulas magistrales de hidrocortisona oral para pediatría
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tolerability and acceptance of two oral hydrocortisone medications for Pediatrics
    Tolerabilidad y aceptación de dos medicamentos orales con hidrocortisona para pediatría
    A.4.1Sponsor's protocol code numberHIDROGUM21
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVall d'Hebron Hospital Universitari
    B.1.3.4CountrySpain
    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 supportVall d'Hebron Hospital Universitari
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVall d'Hebron Hospital Universitari
    B.5.2Functional name of contact pointServei de Farmacia
    B.5.3 Address:
    B.5.3.1Street AddressVall d'Hebron Barcelona Hospital Campus, Passeig Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493489 30006117
    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 Hidrocortisona base (17-Hidroxicorticosterona)
    D.2.1.1.2Name of the Marketing Authorisation holderAcofarma Distribución s.a.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameHidrocortisona Base Acofarma
    D.3.2Product code 1150552
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    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 INNhydrocortisone
    D.3.9.3Other descriptive nameHYDROCORTISONE PH. EUR.
    D.3.9.4EV Substance CodeSUB171070
    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
    Adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency)
    Hiperplasia suprarrenal o insuficiencia suprarrenal primaria aislada o panhipopituitarismo (insuficiencia suprarrenal secundaria o terciaria)
    E.1.1.1Medical condition in easily understood language
    Condition in which the adrenal glands do not produce adequate amounts of steroid hormones.
    Afección en la que las glándulas suprarrenales no producen cantidades adecuadas de hormonas esteroides
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 evaluate the tolerability and acceptance of the two hydrocortisone compounding formulation prepared in the Hospital Pharmacy Service.
    Determinar la tolerabilidad y aceptación de dos fórmulas magistrales de hidrocortisona preparadas en el Servicio de Farmacia del Hospital.
    E.2.2Secondary objectives of the trial
    To evaluate adherence to treatment.
    Evaluar la adherencia al tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Outpatients of both sexes, ≥ 6 years of age without swallowing problems and up to 17 years, at the time of signing the informed consent document by parent (s) or guardian (s) and / or patients.
    - Diagnosis of adrenal hyperplasia or isolated primary adrenal insufficiency or panhypopituitarism (secondary or tertiary adrenal insufficiency)
    -Pacientes ambulatorios de ambos sexos, ≥ 5 años de edad sin problemas de deglución y hasta 17 años, en el momento de la firma del documento del consentimiento informado por (s) progenitor (s) o tutor (es) y / o pacientes.
    -Diagnóstico de hiperplasia suprarrenal o insuficiencia suprarrenal primaria aislada o panhipopituitarismo (insuficiencia suprarrenal secundaria o terciaria).
    E.4Principal exclusion criteria
    -Known hypersensitivity to any of the excipients in the hydrocortisone compounding.
    -Any disorder or situation (decompensation) that, in the opinion of the medical researcher, poses a risk of not complying with the treatment.
    -Hipersensibilidad conocida a alguno de los excipientes de la formulación magistral de hidrocortisona.
    -Cualquier trastorno o situación (descompensación) que, en opinión del médico investigador, suponga un riesgo de no cumplir el tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The sensory acceptability of the formulation will be evaluated taking into account the shape, taste and color of the different hydrocortisone magisterial formulas independently for each attribute. The chewable formulation of hydrocortisone will be changed color and flavor every 15 days in order to select the best presentation of the compounding formulation and improve adherence to the prescribed treatment. Acceptability will be measured through the hedonic facial scale. This type of test has been carried out with children, who have the possibility of evaluating whether or not they like the product without considering language, social condition, or geographical or cultural background.

    Tolerability will be determined by asking on a five-point hedonic facil scale: if the patient refuses the medication, spits the medication, and if they are willing to take the medication again in the future.
    La aceptabilidad sensorial de la formulación será evaluada teniendo en cuenta, la forma, el sabor y el color de las diferentes fórmulas magistrales de hidrocortisona de forma independiente para cada atributo. A la formulación masticable de hidrocortisona se le cambiará el color y sabor cada 15 días con el fin de seleccionar la mejor presentación de la fórmula magistral y mejorar la adherencia al tratamiento prescrito. La aceptabilidad se medirá a través de la escala facial hedónica. Este tipo de pruebas se han llevado a cabo con niños, los cuales tienen la posibilidad de evaluar si les gusta o no el producto sin considerar el lenguaje, condición social ni antecedentes geográficos o culturales.

    La tolerabilidad se determinará preguntando en una escala de cinco puntos: si el paciente rechaza la medicación, escupe la medicación, y si tiene voluntad de volver a tomar la medicación en un futuro.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Monthly: In each medical visits
    Mensualmente: En cada una de las visitas medicas
    E.5.2Secondary end point(s)
    Adherence will be estimated with the medication count and the pharmacy dispensing record.
    La adherencia se estimará con el recuento de la medicación y el registro de dispensación de farmacia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monthly: In each of the pharmacy visits to collect the medication.
    Mensualmente: En cada una de las visitas a farmacia para recoger la medicación.
    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 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 Yes
    E.6.13.1Other scope of the trial description
    To determine the tolerability and acceptance of two hydrocortisone compounding formulation.
    Determinar la tolerabilidad y aceptación de dos formulaciones magistrales de hidrocortisona.
    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 Yes
    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
    Diferentes formulaciones magistrales de hidrocortisona.
    Diferent magistral formulation of hydrocortisone.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Six months after the inclusion of the last patient in the study.
    Después de 6 meses de la inclusión del último paciente del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 35
    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: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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 state35
    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)
    None
    Ninguno
    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 Decision2022-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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