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    Summary
    EudraCT Number:2019-004983-23
    Sponsor's Protocol Code Number:201900874
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-09-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-004983-23
    A.3Full title of the trial
    Bioequivalence study of prednisolone and dexamethasone: corticosteroids revisited
    Bio-equivalentie studie naar de effecten van prednisolon en dexamethason: corticosteroïden opnieuw onder de loep
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Medication comparison studie of prednisolone and dexamethasone
    Medicatie vergelijkingsstudie naar prednisolon en dexamethason
    A.3.2Name or abbreviated title of the trial where available
    CORE study
    CORE studie
    A.4.1Sponsor's protocol code number201900874
    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 SponsorUniversity Medical Center Groningen
    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 supportUniversity Medical Center Groningen
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointSuzanne P. Stam
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031053617293
    B.5.6E-mails.p.stam@umcg.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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namePrednisolone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namePrednisolone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 3
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDexamethasone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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.IMP: 4
    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 Dexamethasone
    D.2.1.1.2Name of the Marketing Authorisation holderCentrafarm B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameDexamethasone
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    This study does not investigate a medical condition and is performed in healthy volunteers.
    Deze studie onderzoekt geen ziekte en wordt uitgevoerd in gezonde vrijwilligers.
    E.1.1.1Medical condition in easily understood language
    This study does not investigate a medical condition, but it will investigate the effect of 2 immunosuppressive medication on the body systems, such as the bodies stress system and immune system.
    Deze studie onderzoekt geen ziekte, maar zal de effecten van 2 immunosuppressieve medicijnen onderzoeken op meerdere onderdelen van het menselijk lichaam, o.a. het stresssysteem en het immuunsysteem.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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
    The main objectieve of the current clinical trial is to re-examine the bioequivalance of prednisolone and dexamethasone on multiple physiological components of the human body, including the hypothalamic-pituitary-adrenal axis (HPA-axis).
    Het hoofddoel van de huidige studie is om de bio-equivalentie van prednisolon en dexamethason opnieuw onder de loep te nemen, voor verschillende fysiologische componenten van het menselijk lichaam, inclusie de hypothalamus-hypofyse-bijnieras
    E.2.2Secondary objectives of the trial
    - To compare and examine the effects of prednisolone and dexamethasone in a (double-blind) randomized clinical trial
    - To study the (potential difference in) effects of prednisolone and dexamethasone using modern and more accurate laboratorytechniques.
    - Het vergelijken van prednisolon en dexametason in een (dubbelblinde) randomized clinical trial
    - To study the (potential difference in) effects of prednisolone and dexamethasone using modern and more accurate laboratory techniques.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participants must be healthy with no relevant medical history and no use of medication.
    2. Female participants must be using oral contraceptives
    3. Command of the Dutch language
    4. Providing written IC
    5. BMI between 18.5 and 30 kg/m2
    1. Deelnemers moeten gezond zijn zonder relevante medische voorgeschiedenis en mogen geen medicatie gebruiken
    2. Vrouwelijke deelnemers moet orale anticonceptie gebruiken
    3. Deelnemers moeten de Nederlandse taal beheersen
    4. Deelnemers moeten geschreven informed consent leveren
    5. Deelnemers moeten een BMI tussen de 18.5 en 30 kg/m2 hebben.
    E.4Principal exclusion criteria
    1. Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
    2. Potential participants with a medical history of:
    a. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
    b. Diseases affecting the HPG-axis: e.g. diabetes
    c. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
    d. Psychiatric diseases
    e. Diabetes

    3. Shift workers.
    4. Potential participants with a kidney function <60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
    5. Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
    6. Potential participants who utilize any medication which is likely to confound assessment of the endpoint (e.g. inhaled corticosteroids, hormone supplements, psychotropic drugs, carbamazepine or vaccination)
    7. Potential participants who have known contraindication to the study medication (e.g. known peptic ulcer disease or active infectious disease)
    8. Potential participants who intend to undergo significant lifestyle changes e.g. voluntary weight loss and discontinue smoking habits.
    Potentieel deelnemers die niet geschikt zijn om mee te doen aan de huidige studie zijn:
    1. Potentiële deelnemers die zich met grote zekerheid niet aan het studie protocol zullen houden (bijv. mensen met een voorgeschiedenis van middelenmisbruik of therapie ontrouw)
    2. Potentiële deelnemers met een medische voorgeschiedenis van:
    a. Aandoeningen van de HPA-as: bijv. primaire of secundaire bijnierschorinsufficiëntie, hypofyse tumoren en mensen die nachtdiensten werken
    b. Aandoeningen die effect hebben op de HPG-as: bijv. diabetes
    c. Chronische inflammatoire ziekten bijv. reumatoïde artritis, polymyalgia rheumatica en astma
    d. Psychiatrische aandoeningen

    3. Mensen die in ploegendienst werken
    4. Potentiële deelnemers met een nierfunctie <60 ml/min/1.73m2, afwijkende leverwaarden en/of abnormale schildklierfunctie
    5. Potentiële deelnemers die afhankelijk zijn van corticosteroïden zoals patiënten met astma en transplantatie patiënten
    6. Potentiële deelnemers die medicatie gebruiken welke met grote zekerheid een interactie heeft met een van de eindpunten (bijv. inhalatie corticosteroïden, hormoon supplementen, psychotrope medicatie, carbamazepine of vaccinaties
    7. Potentiële deelnemers die een contra-indicatie hebben tegen de studie medicatie (bijv. maagzweren of actieve infectie)
    8. Potentiële deelnemers die van plan zijn om gedurende de studieperiode grote leefstijlveranderingen door te voeren zoals bewust gewichtsverlies en stoppen met roken.




    E.5 End points
    E.5.1Primary end point(s)
    The primary study parameter will be the bioequivalence of prednisolone and dexamethasone as determined by the level of suppression of total cortisol excretion in 24h-urine between low dose prednisolone and dexamethasone and high dose prednisolone and dexamethasone.
    Het primaire eindpunt van de studie is de bio-equivalentie van prednisolon en dexamethason. Dit eindpunt wordt afgemeten aan de mate van suppressie van de totale cortisol excretie in 24h urine tussen de lage dosis prednisolon en dexamethason en tussen de hoge dosis prednisolon en dexametason.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All study visits ( 5 times)
    Alle studievisites (5 keer)
    E.5.2Secondary end point(s)
    Secondary study parameters will be:
    - Suppression of the HPA-axis measured by plasma cortisol, adrenocorticotropic hormone, and metabolites in the steroid profile in 24h urine (e.g. free and total cortisol, tetrahydrocortisol, tetrahydrocortisone, and allo-tetrahydrocortisol).
    - Suppression of the HPG-axis measured by testosterone, LH, FSH, SHBG, dihydrotestosterone, and steroid profile in 24h urine (e.g. androsterone, etiocholanolone, and dehydroepiandrosterone).
    - The pharmacokinetics and pharmacodynamics of prednisolone and dexamethasone.
    - Suppression of the immune system measured by leucocyte count, granulocyte count (neutrophils, eosinophil’s, and basophils), monocyte count, absolute B cell (CD19+) count, absolute T cell (CD3+, CD4+ and CD8+) count, absolute natural killer cell (CD16+ en CD56+) count, and RNA.
    - Renin–angiotensin–aldosterone system measured by plasma renin, aldosterone, potassium, 24h urine potassium, and trans-tubular potassium gradient.
    - Muscle mass measured by 24h urinary creatinine excretion rate and creatine kinase.
    - Metabolic parameters measured by fasting glucose, fasting insulin, HbA1c, cholesterol, triglycerides, glycerol, and non-esterified fatty acids.
    - Bone status as measured by calcium and osteocalcin
    - Clinical parameters: body weight, height, waist circumference, hip circumference, blood pressure
    - Neurocognitive function as measured by CanTab Cognitive and Psychological test
    Secundaire eindpunten zijn:
    - Suppressie van de HPA-as gemeten aan: het plasma cortisol, ACTH en cortisol metabolieten in 24h urine (bijv. vrij en totaal cortisol, tetrahydrocortisol, tetrahydrocortisol, tetrahydrocortisone, and allo-tetrahydrocortisol)
    - Suppressie van de HPG-as gemeten aan: testosteron, LH,FSH, SHBG, DHT, en androgeen metabolieten in 24h urine (bijv. androsterone, etiocholanolone, and dehydroepiandrosterone).
    - De farmacokinetiek en farmacodynamiek van prednisolon en dexamethason.
    - Suppressie van het immuunsysteem
    - Spiermassa
    - Bot parameters
    - Klinische uitkomstmaten
    - Neurocognitief functioneren
    E.5.2.1Timepoint(s) of evaluation of this end point
    All study visits ( 5 times)
    Alle studievisites (5 keer)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence Yes
    E.6.9Dose response Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Dexamethason
    Dexamethasone
    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
    LVLS
    De laatste studie visite van de laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 24
    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 Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    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)
    Because the participants are healthy subjects and therefore do not undergo a specific treatment which could be altered. Participants will be advised to contact their own local general practitioner with any new medical symptoms or medical condition.
    Omdat de deelnemers van deze studie gezonde personen zijn ondergaan zijn geen specifieke behandeling die aangepast kan worden. Alle deelnemers zijn willen geadviseerd om contact te zoeken met hun eigen huisarts bij het ontstaan van nieuwe medische symptomen of een nieuwe medische conditie.
    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 Decision2020-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-18
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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