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    Summary
    EudraCT Number:2016-004078-16
    Sponsor's Protocol Code Number:DOSCORT20092231
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-05
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004078-16
    A.3Full title of the trial
    A dose-response study of markers of glucocorticoid action (DOSCORT)-
    A double-blind, randomized, two-period, two-dose, cross-over study in subjects with primary adrenal insufficiency
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of markers of glucocorticoid effects
    A.3.2Name or abbreviated title of the trial where available
    DOSCORT
    DOSCORT
    A.4.1Sponsor's protocol code numberDOSCORT20092231
    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 SponsorSahlgrenska University Hospital, Gothenburg
    B.1.3.4CountrySweden
    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 supportSwedish government funding ALF-agreement
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish research counsil
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital
    B.5.2Functional name of contact pointDepartment of Endocrinology
    B.5.3 Address:
    B.5.3.1Street AddressMedicinmottagning 1, bl str 5, 1 trp, Sahlgrenska University Hospital
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code413 45
    B.5.3.4CountrySweden
    B.5.4Telephone number+46735941221
    B.5.6E-mailjohanna.mcqueen@gu.se
    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 Betametason Evolan 0,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderEvolan Pharma AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameBetametason Evolan 0,5 mg tablet
    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 INNBETAMETHASONE
    D.3.9.3Other descriptive nameBetametason
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Betametason Evolan 0,5mg
    D.2.1.1.2Name of the Marketing Authorisation holderEvolan Pharma AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameBetametason Evolan 0,5mg tablet
    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 INNBETAMETHASONE
    D.3.9.3Other descriptive nameBetametason
    D.3.9.4EV Substance CodeSUB07017MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 insufficiency e.g. Addison´s disease
    E.1.1.1Medical condition in easily understood language
    Patients with Addison´s disease completely lack production of glucocorticoids (steroidhormones),which are essential for life as they play an important role for a wide range of physiological functions.
    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 demonstrate a glucocorticoid dose response of potential biomarker(s), in blood and/or saliva and/or urine using omics analyses, in patients with Addison´s disease receiving alower physiological and a higher physiological glucocorticoid dose during 7 days each.
    E.2.2Secondary objectives of the trial
    To investigate a glucocorticoid dose response of

    1. bone markers, lipid profile and glucose metabolism through blood sample analyses,
    2. self-reported health-related quality of life and general well-being using validated questionnaires and
    3. daily physical activity using a wrist warn accelerometer and sleep quality using and wrist warn sleep monitor

    in patients with Addison´s disease receiving a lower physiological and higher physiological glucocorticoid dose during 7 days each.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Males and females at ages 20-65 years
    •Previously diagnosed (e.g. more than 12 months ago) with primary adrenal insufficiency due to autoimmune adrenalitis, i.e. Addison´s disease
    •A stable daily glucocorticoid replacement dose for at least 3 months prior to study entry
    •An oral glucocorticoid replacement dose of 15-30 mg Hydrocortisone total daily dose
    •If needed, a stable fludrocortisone replacement dose for at least 3 months prior to study entry
    •Body mass index (BMI) of 20-35 kg/m2
    •Ability to comply to the protocol procedures and having signed informed consent to participate in the study
    E.4Principal exclusion criteria
    •Clinical or laboratory signs of significant cerebral, cardiovascular, respiratory, hepaticobiliary/ pancreatic disease which in the investigators judgement may interfere with the study assessment of completion of the study
    •Clinically significant renal dysfunction with a serum creatinine above 150 mmol/L
    •Pregnant or lactating women
    •Diabetes Mellitus
    •Systemic infections
    •Regular dehydroepiandrosterone (DHEA) medication for the past 4 weeks
    •Any medication with agents which in the investigators judgement might interfere with the study drugs kinetics, including therapies affecting gastro intestinal emptying or motility
    •Alcohol/drug abuse or any other condition associated with poor patient compliance, including expected non-cooperation, as judged by the investigator
    •Hypersensitivity to the active substance or any excipients used in the study drug of choice
    •Any additional underlying disease that may need regular or periodic pharmacological treatment with glucocorticoids during the trail, such as asthma, skin- or eye conditions treated with inhaled or topical glucocorticoids
    •Any additional underlying condition that needs treatment with intramuscular or intra-articular steroid injections during the trial
    E.5 End points
    E.5.1Primary end point(s)
    Difference in expression of the circulating plasma microRNA, miR-122, from baseline to end of treatment between the two doses of glucocortikoid (BMA).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and after one week of treatment with a lower physiological glucocorticoid (BMA) dose (test week).
    Baseline and after one week of treatment with a higher physiological glucocorticoid (BMA) dose (test week).

    There will be a wash-out period of 2-5 weeks in between the two test-weeks.
    E.5.2Secondary end point(s)
    •Difference in expression of other miRNAs, small metabolites, proteins and glucocorticoid metabolites in blood, saliva and urine from baseline to end of treatment between the two doses of BMA.
    •Difference in serum pro-collagen type 1 N-terminal pro-peptid (P1NP), carboxy-terminal collagen crosslinks (CTX), total-,LDL- and HDL-cholesterol, triglycerides, lipoprotein A and B, fp-glukos, f-serum-insulin and HbA1c from baseline to end of treatment between the two doses of BMA.
    •Difference in self reported quality of life and well-being based on validated questionnaires: Addison-specific quality-of-life (ADDIQoL), the Psychological General Well-Being (PGWB) index, the Fatigue Impact Scale (FIS) and the Functional Outcomes of Sleep Questionnaire (FOSQ) between the two doses of BMA.
    •Difference in physical activity data generated from the wrist warn activity monitor ActiGraph GT3X and sleep data generated from WatchPATTM200U between the two doses of BMA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionnaires and blood sampling:
    • Baseline and end of treatment of the two treatment periods.

    Physical activity:
    • 24h/ day during the two treatment periods. Data collection at the end of each treatment period.

    Sleep quality:
    • The last two night of each treatment period. Data collection at the end of each treatment period.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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
    A low psysiological and high physiological glucocorticoid (Betamethason) dose
    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
    The end of the trial will be a follow-up phone call made by the study physician 2-6 weeks after the last study subjects’ last visit.
    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: 30
    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 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 state30
    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
    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 Decision2020-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
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