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    Summary
    EudraCT Number:2011-002687-25
    Sponsor's Protocol Code Number:PHYSCA-1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-10-06
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-002687-25
    A.3Full title of the trial
    Pharmacokinetics of Hydrocortisone after Subcutaneous Administration Compared with Intramuscular Injection in Chronic Adrenal Insufficiency
    (PHYSCA-Trial)
    Pharmakokinetik der subkutanen Hydrocortisonapplikation im Vergleich zur intramuskulären Gabe bei chronisch Nebenniereninsuffizienten Patienten (PHYSCA- Studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the time to cortisol levels required in critical illness (>1000 nmol/l) and safety of hydrocortisone, after subcutaneous injection in patients with chronic primary adrenal insufficiency
    (Comparison s.c. vs. i.m.)
    Untersuchung der Zeit bis zum Erreichen relevanter Wirkspiegel (>1000 nmol/l) und der Sicherheit der subkutanen Hydocortisongabe, im Vergleich zur Gabe in den Muskel, bei Patienten mit einer chronischen Nebenniereninsuffizienz
    A.3.2Name or abbreviated title of the trial where available
    PHYSCA- Trial
    PHYSCA- Studie
    A.4.1Sponsor's protocol code numberPHYSCA-1
    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 Hospital of Wuerzburg
    B.1.3.4CountryGermany
    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 Hospital Wuerzburg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDept. of Endocrinology, Dept. of Medicine I, University Hospital Wuerzburg
    B.5.2Functional name of contact pointPD Dr. med. Stefanie Hahner
    B.5.3 Address:
    B.5.3.1Street AddressOberduerrbacher Str. 6
    B.5.3.2Town/ cityWuerzburg
    B.5.3.3Post code97080
    B.5.3.4CountryGermany
    B.5.4Telephone number+4993120139937
    B.5.5Fax number+49931201639200
    B.5.6E-mailhahner_s@medizin.uni-wuerzburg.de
    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 Yes
    D.2.1.1.1Trade name Hydrocortison 100 mg (Pfizer®) in 2 ml solvent
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder and solvent for solution for injection
    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 INNHydrocortisone
    D.3.9.1CAS number 8000042-97-9
    D.3.9.3Other descriptive nameHYDROCORTISONE HYDROGEN SUCCINATE
    D.3.9.4EV Substance CodeSUB14133MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Adrenal insufficiency
    under chronic glucocorticoid replacement
    Nebenniereninsuffizienz unter Standardsubstitution mit Hydrocortison
    E.1.1.1Medical condition in easily understood language
    Adrenal insufficiency
    Nebenniereninsuffizienz
    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 PT
    E.1.2Classification code 10001130
    E.1.2Term Addison's disease
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10052381
    E.1.2Term Primary adrenal insufficiency
    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
    Evaluation of the pharmacokinetics of hydrocortisone after subcutaneous injection (s.c.) for use in adrenal emergency
    Untersuchung der Pharmakokinetik der subkutanen Hydrocortisonapplikation
    E.2.2Secondary objectives of the trial
    Evaluation of the safety and feasibility of hydrocortisone after subcutaneous injection (s.c.) for use in adrenal emergency
    Untersuchung der Sicherheit der subkutanen Hydrocortisonapplikation
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients with chronic primary adrenal insufficiency due to autoimmune adrenalitis or bilateral adrenalectomy
    Patienten mit chronischer primärer Nebenniereninsuffizienz, Morbus Addison oder Zustand nach bilateraler Adrenalektomie
    E.4Principal exclusion criteria
    Diabetes mellitus, fever at time of investigation, oral contraception, pregnancy, breast feeding, renal failure, intolerance to the study drug or constituents
    Diebetes mellitus, fieberhafter Infekt zum Zeitpunkt der Untersuchung, orale Kontrazeption, Schwangerschaft, Stillzeit, Niereninsuffizienz, bekannte Allergie gegenüber Bestandteilen des Prüfpräparates
    E.5 End points
    E.5.1Primary end point(s)
    The primary clinical endpoint is the time to cortisol levels required in critical illness (>1000 nmol/l). Comparison s.c. vs. i.m. and the number of patients achieving this level. The hypothesis is that this serum levels can be achieved within a critical time frame of 30 min after subcutaneous injection with good safety and higher patient acceptance compared to intramuscular administration. Further end points are pharmacokinetic data for assessment of bioequivalence: Cmax: maximal plasma concentration; Cmin: minimal plasma concentration; Cav: average plasma concentration; tmax: time passed since administration at which the plasma concentration maximum occurs; AUCt: area under the plasma concentration curve from administration to last observed concentration at time t. MRT: mean residence time; t1/2: plasma concentration half-life; Fluctuation: (Cmax - Cmin)/Cav.
    Secondary end points are the safety of subcutaneous hydrocortisone administration and the response of ACTH levels to glucocorticoid administration as a second indirect measure of physiological glucocorticoid activity. Further patient acceptability of the different modes of glucocorticoid administration will be assessed.
    Pharmakokinetik von Hydrocortison nach subkutaner Gabe,
    Zeit bis zum Erreichen von Cortisolspiegeln, die als “sicher” bei schwerer Erkrankung erachtet werden (>36 µg/dl, >1000 nmol/l) nach subkutaner vs. intramuskulärer Gabe
    pharmakokinetische Daten: Cmax: maximal plasma concentration; Cmin: minimal plasma concentration; Cav: average plasma concentration; tmax: time passed since administration at which the plasma concentration maximum occurs; AUCt: area under the plasma concentration curve from administration to last observed concentration at time t. MRT: mean residence time; t1/2: plasma concentration half-life; Fluctuation: (Cmax - Cmin)/Cav.
    E.5.1.1Timepoint(s) of evaluation of this end point
    blood sampling after 5 to 240 min after administration of the study medication, final assessment by questionnaires after last intervention.
    Blutentnahmen nach 5 bis 240 min nach Verabreichung des Hydrocortisonpräparats (an drei untersuchungstagen)
    E.5.2Secondary end point(s)
    safety and tolerability by the patient compared to intramuscular administration
    Sicherheit und Patientenakzeptanz der subkutanen Gabe im Vergleich zur intramuskulären Gabe.
    E.5.2.1Timepoint(s) of evaluation of this end point
    final assessment by questionnaires after last intervention
    Untersuchungsende mit Beantwortung eines Fragebogens
    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 No
    E.6.8Bioequivalence Yes
    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 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 Yes
    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 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
    Last entry in the patient diary (three days after final study visit with final adminsitration of the study medication) of the last patient included.
    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 months6
    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 months6
    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 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: 12
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2011-10-06. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 12
    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)
    No difference in long term treatment of the clinical condition of study participants. Single treatments are performed within the trial. Patients are seen on a regular basis in our outpatient clinic.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-07-13
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