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    Summary
    EudraCT Number:2011-000864-82
    Sponsor's Protocol Code Number:hydrocortisone
    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:2011-11-23
    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 number2011-000864-82
    A.3Full title of the trial
    A randomized double blind cross-over study of the effects of low dose and high dose hydrocortisone replacement therapy on cognition, quality of life, metabolic profile and somatosensation in patients with secondary adrenal insufficiency
    Een gerandomiseerde dubbelblinde cross-over studie naar de effecten van een lage en hoge dosis hydrocortison substitutie op cognitie, kwaliteit van leven, metabool profiel en gevoelswaarneming bij patiënten met secundaire bijnierschorsinsufficientië
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An intervention study of the effects of a low dose and high dose hydrocortisone replacement therapy on brain functions, quality of life, risk factors for cardiovascular diseases and sensitivity in patients with adrenal insufficiency due to a previous pituitary tumor.
    Een interventie studie naar de effecten van een lage en hoge dosis hydrocortison substitutie therapie op hersenfuncties, kwaliteit van leven, risicofactoren voor hart- en vaatziekten en gevoeligheid bij patiënten met bijnierschorsinsufficiëntie ten gevolge van een hypofyse tumor.
    A.3.2Name or abbreviated title of the trial where available
    Hydrocortisone replacement in patients with secondary adrenal insufficiency
    Hydrocortison vervanging bij patiënten met secundaire bijnierschorsinsufficiëntie
    A.4.1Sponsor's protocol code numberhydrocortisone
    A.5.4Other Identifiers
    Name:ABR Number:35668
    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 pointDepartment of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressHanzeplein 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9700RB
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31503613962
    B.5.5Fax number+31503619392
    B.5.6E-mailn.alma@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 Hydrocortisone
    D.2.1.1.2Name of the Marketing Authorisation holderTiofarma
    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 namehydrocortisone
    D.3.2Product code CAS 50237
    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.3.9.1CAS number 50-23-7
    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 number15 to 40
    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) Yes
    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
    Secondary adrenal insufficiency
    Secundaire bijnierschorsinsufficiëntie
    E.1.1.1Medical condition in easily understood language
    adrenal insufficiency

    Bijnierinsufficiëntie
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10020518
    E.1.2Term Hydrocortisone
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to investigate whether a physiologically low HC dose is better for cognition as compared to a high HC dose.
    Het doel van deze studie is het onderzoeken of een fysiologisch lage HC dosis beter is voor cognitie dan een hoge HC dosis.
    E.2.2Secondary objectives of the trial
    In addition, quality of life, metabolic profile and somatosensation will be described in relation to HC dose.
    Bovendien worden kwaliteit van leven, het metabool profiel en gevoelswaarneming beschreven in relatie tot de HC dosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with secondary adrenal insufficiency without prior evidence of hormonal overproduction (e.g. acromegaly, Cushing disease and prolactinoma).
    Age ≥ 18 – 70 years
    ≥ One year after tumor treatment with surgery and/or radiotherapy
    On stable concomitant medications for at least six months prior to entry of study
    Body weight 50-100 kg
    Patiënten met secundaire bijnierschorsinsufficiëntie zonder voorgeschiedenis van hormonale overproductie (bijv. acromegalie, ziekte van Cushing en prolactinoom).
    Leeftijd ≥ 18 - 70 jaar
    ≥ Een jaar na de tumor behandeling met chirurgie en / of bestraling
    Op een stabiele co-medicatie gedurende ten minste zes maanden voorafgaand aan de toetreding van de studie
    Lichaamsgewicht 50-100 kg
    E.4Principal exclusion criteria
    Inability of legal consent
    Documented cognitive impairment
    Drug abuse/dependence
    History of or current psychiatric disorders
    Drugs that interact with hydrocortisone Use of anti-epileptics (e.g. carbamezapine)
    Premenopausal women (because of effects of estrogens on cortisol binding globulin and because differences in HPA axis functioning in the luteal or follicular phase)
    Type 1 or Type 2 diabetes
    Current treatment for second malignancy
    Have a significant medical condition (e.g. hepatic, respiratory, or cardiovascular) which, in the opinion of the investigator, may interfere with the interpretation of results and safety or efficacy evaluations.
    A history of frequent hypocortisolism
    Hospitalization during study
    Work in shifts
    Wilsonbekwaam
    Gedocumenteerde cognitieve stoornissen
    Drugsmisbruik / afhankelijkheid
    Geschiedenis van of huidige psychiatrische stoornissen
    Gebruik van anti-epileptica (bijv. carbamazepine)
    Premenopauzale vrouwen (vanwege de effecten van oestrogenen op cortisol bindend globuline en vanwege verschillen in de HPA-as functioneren in de luteale of folliculaire fase)
    Type 1 of type 2 diabetes
    Huidige behandeling voor de tweede maligniteit
    Aanwezige medische aandoening (bijv. lever-, ademhalings of cardiovasculaire aandoening) die, naar het oordeel van de onderzoeker, kunnen interfereren met de interpretatie van de resultaten en de evaluatie van veiligheid of werkzaamheid.
    Een geschiedenis van frequente hypocortisolism
    Hospitalisatie tijdens studie
    Werken in ploegendienst
    E.5 End points
    E.5.1Primary end point(s)
    Cognitive performance.
    If the significance value is less than .05, there is a significant difference. This will be calculated with a paired samples t-test.
    Cognitieve prestaties.
    Indien het significante verschil kleiner is dan 0.05, is er een significant verschil. Dit zal worden berekend met een gepaarde T-toets.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks)
    Eerste evaluatie vindt plaats na de 4 weken durende run-in fase om een baseline bepaling te doen bij patiënten met een secundaire bijnierschorsinsufficientië. Tweede evaluatie aan het eind van de studie. Dat is 24 weken na de start van de studie (4 weken run-in fase en twee interventie perioden van 10 weken)
    E.5.2Secondary end point(s)
    Quality of Life (QoL),
    Metabolic profile
    Somatosensation
    Kwaliteit van leven
    Metabool profiel
    Gevoelswaarneming
    E.5.2.1Timepoint(s) of evaluation of this end point
    First evaluation after 4 weeks run-in phase to assess baseline functioning in patients with secundairy insufficiency.
    Second evaluation at the end of the study. That is after 24 weeks after initiation of the study (4 weeks run-in phase and two intervention periods of 10 weeks)
    Eerste evaluatie vindt plaats na de 4 wekende durende run-in fase om een baseline bepaling te doen bij patiënten met een secundaire bijnierschorsinsufficientië. Tweede evaluatie aan het eind van de studie. Dat is 24 weken na de start van de studie (4 weken run-in fase en twee interventie perioden van 10 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 Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    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 Yes
    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
    verschillende dosering van hetzelfde medisch product
    a different dose of the same medicinal product
    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
    It is the last visit of the last subject undergoing the trial.
    De laatste testafname van de laatste patient die mee doet aan dit onderzoek.
    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 months0
    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 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: 33
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state66
    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)
    In case of participant’s potential preference to either dosing scheme this scheme can be continued in consultation with the attending physician.
    In het geval van een patient zijn/haar voorkeur voor één van beide doseringsschema's kan ik overleg met de arts dit doseringsshema worden voortgezet.
    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 Decision2011-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-12
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