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    Summary
    EudraCT Number:2018-004802-24
    Sponsor's Protocol Code Number:NL68556.091.18
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-13
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004802-24
    A.3Full title of the trial
    Optimizing timing of glucocorticoid treatment in children with congenital
    adrenal hyperplasia
    Vermijden van over en onderbehandeling door optimalisatie van de timing
    van cortisol behandeling bij kinderen met het adrenogenitaal syndroom
    (AGS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Avoiding over and undertreatment by optimizing of the timing of
    glucocorticoïd treatment in children with cnogenital adrenal hyperplasia
    Vermijden van over en onderbehandeling door optimalisatie van de
    timing van glucorticoid behandeling bij kinderen met het adrenogenitala
    syndroom
    A.3.2Name or abbreviated title of the trial where available
    OPTIMED study
    OPTIMED studie
    A.4.1Sponsor's protocol code numberNL68556.091.18
    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 SponsorRadboud University Nijmegen Medical Centre
    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 supportInnovatiefonds Zorgverzekeraars
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Nijmegen medical centre
    B.5.2Functional name of contact pointDepartment of Ped Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grootteplein 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31243614430
    B.5.6E-mailhedi.claahsen@radboudumc.nl
    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.3.1Product nameHydrocortisone
    D.3.4Pharmaceutical form Tablet
    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
    D.3.9.4EV Substance CodeSUB08065MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 5
    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
    Congenital adrenal hyperplasia (CAH) is a disorder of adrenal steroid
    synthesis leading to cortisol deficiency and an increase in androgen
    production.Treatment in children consists of hydrocortisone substitution
    thereby also restoring the negative feedback on the pituitary gland and
    consequently normalize androgen production. There is still no evidence
    about the best timing of hydrocortisone use: The highest dosage of
    hydrocortisone in the morning or the highest dosage at night
    Het adrenogenitaal syndroom (AGS) is een aangeboren ziekte van de
    bijnier, die veroorzaakt wordt door een tekort van het enzym 21-
    hydroxylase, dat nodig is voor de productie van hormonen in de bijnier.
    Door een tekort aan dit enzym wordt onvoldoende cortisol
    (stresshormoon) en tegelijkertijd een overmaat aan mannelijke
    hormonen (androgenen) in de bijnier gemaakt.
    E.1.1.1Medical condition in easily understood language
    CAH is an inherited disease of the adrenal gland with ad deficiency of cortisol and aldosterone. Current treatment consists of lifelong replacement of
    synthetic glucocorticoids.
    het adrenogenitaal syndroom is een ziekte van de bijnier met een tekort
    aan hormonen cortisol en zouthormoon. behandling bstaat uit het
    toedienen van deze hormonen
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 study the effects of 2 standard treatment timing strategies for glucocorticoid dosage on androgen concentration in CAH children: a. highest dosage in the morning, b. highest dosage in the evening.
    Wij willen graag evalueren welke van de 2 behandelopties leidt tot de
    beste onderdrukking van bijnier androgenen.
    E.2.2Secondary objectives of the trial
    12 hours blood pressure and activity
    and sleeping patterns during the 2 treatment strategies.
    12 uurs bloeddruk meting en slaappatroon
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Children with CAH due to 21-hydroxylase deficiency > 4 years old and
    < 18 years old
    • The diagnosis is confirmed by mutation analysis
    • Patient are treated with hydrocortisone according to standard
    guidelines in a thrice daily schedule
    • Ability to collect saliva
    Kinderen met AGS tussen 4 - 18 jaar ouder
    Diagnose bevestigd middele genetische analyse
    Behandeling met hydrocortion
    in staat zijn om speeksel te sparen
    E.4Principal exclusion criteria
    •Other forms of CAH
    •Not able to collect saliva
    •Chronical medication use other than hydrocortisone and
    fludrocortisone
    andere vormen van AGS
    niet in staat om speeksel te verzamelen
    co medicatie anders dan hydrocortison en fludrocortison
    E.5 End points
    E.5.1Primary end point(s)
    17-hydroxyprogesterone and androstenedione levels measured in saliva
    four times a day after 3 weeks of treatment with the 2 different timing
    strategies. We will compare differences in levels of 17 OHP and A.
    between the 2 dose schedules.
    17-hydroxyprogesterone and androstenedione concentraties gemeten in
    speeksel na 3 weken behandeling in de 2 verschiillende dosis
    verdelingen
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of each 3 week period
    aan het einde van elke 3 weken
    E.5.2Secondary end point(s)
    12 hour blood pressure and sleeping patterns during the 2 treatment
    strategies.
    12 uurs bloeddruk meting en slaappatroon
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily sleeping score
    RR once after every 3 week period
    daily sleepping score
    Bloeddruk een keer per 3 weken
    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 Yes
    E.6.4Safety No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 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 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
    LVLS
    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 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: 50
    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: 40
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    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
    children < 16 years old
    kinderen < 16 jaar
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    patients get care as usual
    patienten gebruiken hun eigen medicatie
    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 Decision2019-05-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-06-14
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