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    Summary
    EudraCT Number:2017-005050-11
    Sponsor's Protocol Code Number:SeMMIviD
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-06
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-005050-11
    A.3Full title of the trial
    Effects of Selenium and cholecalciferol on hyperthyroidism due to Graves' disease treated with methimazole: a randomized, clinical, open label, pilot trial
    Studio clinico randomizzato pilota in aperto per valutare l'efficacia dell'associazione Selenio, colecalciferolo e metimazolo nella terapia dell'ipertiroidismo in pazienti con morbo di Basedow e concomitante deficit di Selenio e ipovitaminosi D
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Selenium and vitamin D in the treatment of thyroid hormone excess
    Effetto combinato del trattamento con Selenio e vitamina D in condizioni di eccessiva secrezione di ormoni tiroidei
    A.3.2Name or abbreviated title of the trial where available
    SeMMIviD
    SeMMIviD
    A.4.1Sponsor's protocol code numberSeMMIviD
    A.5.4Other Identifiers
    Name:SeMMIviDNumber:2017-005050-11
    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 SponsorA.O. OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI
    B.1.3.4CountryItaly
    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 supportfondi del Dipartimento di Medicina e Chirurgia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASST Sette Laghi Varese
    B.5.2Functional name of contact pointSC Endocrinologia, ASST Sette Laghi
    B.5.3 Address:
    B.5.3.1Street AddressViale Borri 57
    B.5.3.2Town/ cityVarese
    B.5.3.3Post code21100
    B.5.3.4CountryItaly
    B.5.4Telephone number0332278325
    B.5.5Fax number0332393308
    B.5.6E-mailluigi.bartalena@uninsubria.it
    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 DIBASE - 300.000 UI/ML SOLUZIONE INIETTABILE PER USO ORALE E INTRAMUSCOLARE 2 FIALE 1 ML
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDIBASE
    D.3.4Pharmaceutical form Oral solution
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 DIBASE - 10.000 UI/ML GOCCE ORALI, SOLUZIONE FLACONE CON GONTACOCCE 10 ML
    D.2.1.1.2Name of the Marketing Authorisation holderABIOGEN PHARMA S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDIBASE
    D.3.4Pharmaceutical form Oral solution
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 TAPAZOLE - 5 MG COMPRESSE BLISTER IN PVC/AL DA 100 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderTEOFARMA S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTapazole
    D.3.4Pharmaceutical form Tablet
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Graves' disease
    Morbo di Basedow o Graves'
    E.1.1.1Medical condition in easily understood language
    High levels of thyroid hormones due to toxic diffuse goiter in autoimmune disorder
    Eccesso di ormoni tiroidei da gozzo diffuso di origine autoimmune
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10020850
    E.1.2Term Hyperthyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with methimazole to treat hyperthyroidism due to Grave's diseas after 180 days from enrollment.



    -Valutare l’efficacia della associazione di Selenio e colecalciferolo alla terapia standard con metimazolo in pazienti affetti da morbo di Basedow naïves con deficit documentato di Selenio e vitamina D, sul controllo biochimico e clinico dell’ipertiroidismo dopo 180 giorni di terapia.
    E.2.2Secondary objectives of the trial
    -To test the efficacy of concomitant therapy of Selenium and cholecalciferol in association to the standard therapy with metimazole to treat hyperthyroidism due to Grave's diseas after 45 and 240 days from enrollment.
    -To test parameters of oxidative metabolism and t reg profile as possible indicator of efficacy
    --Mean dose of methimazole
    - Ultrasound thyroid morphology/echogenicity
    -.valutare l'efficacia della associazione Selenio e colecalciferolo alla terapia standard con metimazolo nel controllo dell'ipertiroidismo da morbo di Basedow dopo 45 e 240 giorni dall'inizio del trattamento.
    Valutare la possibilità di utilizzare una dose inferiore di metimazolo nel gruppo di terapia
    -Valutare l'andamento del metabolismo ossidativo e del profilo dei T reg come possibili indicatori surrogati dell'efficacia del trattamento
    -pattern di ecogenicità tiroideo


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Hyperthyroidism due to Basedow disease
    -selenium and Vitamin D deficiency
    -age 18-70 years; Caucasian race
    -no concomitant major cardiovascular, haepatic, haemopoietic disease
    -vitamin D malabsorption (intestinal inflammatory chronic diseases, alcoholism, cystic fibrosis)
    - II-III grade obesity
    - no concomitant supplementation with vitamin D and/or Selenium
    -informed consent
    -Ipertiroidismo non trattato dovuto a morbo di Basedow.
    -Deficit di Selenio
    -Ipovitaminosi D
    -Etnia caucasica
    -Età compresa tra 18 e 70 anni
    -Assenza di comorbilità che influenzino lo stress ossidativo (diabete mellito scompensato, cardiopatia ischemica, insufficienza epatica moderata/severa, insufficienza renale moderata/severa, alcolismo cronico)
    -Assenza di altre condizioni che influenzino la conta cellulare plasmatica (malattie dell’emopoiesi)
    -Assenza di altre condizioni che influenzino l’assorbimento e il metabolismo della vitamina D (malassorbimento intestinale, mucoviscidosi, fibrosi cistica, insufficienza epatica), alcolismo cronico, obesità di II e III grado
    -Buone condizioni di salute generale, salvo le manifestazioni dell’ipertiroidismo
    -Dieta priva di alimenti arricchiti con Selenio e/o vitamina D
    -Firma del modulo del consenso informato
    E.4Principal exclusion criteria
    intolerance to methimazole
    intolerance to Selenium (actually not known), or to excipients of Syrel
    concomitant conditions interfering with vitamin D metabolism (such as primary hyperparathyroidism, a granulomatous disease, kidney stones, some types of kidney disease, digital therapy
    -.pregnancy, breastfeeding

    -Ipertiroidismo in terapia con antitiroidei di sintesi
    - Controindicazioni al metimazolo (ipersensibilità ai farmaci antitiroidei, gravidanza, allattamento)
    - Eventuali controindicazioni al Selenio (al momento non ci sono controindicazioni descritte), intolleranza nota a olio di semi di soia (glycinesoja), gelatina alimentare, glicerolo, lievito arrichito di Selenio, silice colloidale anidre, Biperine–pepe nero (pipernigrum frutti), E555, E171, E172 (presenti nell’integratore)
    - Eventuali condizioni in cui la vitamina D deve essere prescritta con cautela e sotto stretto monitoraggio: sarcoidosi, insufficienza renale, assunzione di farmaci digitalici
    -Dieta con alimenti arricchiti con Selenio o livelli ematici basali nella norma
    - Dieta con alimenti arricchiti con vitamina D o livelli di 25-OH vitamina D basali nella norma
    - Assunzione di integratori contenenti Selenio o/o altre sostanze anti-ossidanti
    -Assunzione di integratori contenenti vitamina D (in ogni sua formulazione)
    -Incapacità di acconsentire a partecipare allo studio
    E.5 End points
    E.5.1Primary end point(s)
    Biochimical and Clinical manifestation of hyperthyroid after 180 days from baseline. A difference of 3 pg/ml in FT4 levels after 180 days between the treatment group and the standard one is expected.
    -severity of hyperthyroidism assesed with Clinical Severity Score -Thyroid hormone levels (FT4, FT3, TSH) after 180 days from enrollment -Mean dose of methimazole
    Andamento delle manifestazioni cliniche e biochimiche (TSH, FT4, FT3) dell’ipertiroidismo a 180 giorni , ipotizzando di evidenziare come statisticamente significativa una differenza nei livelli di FT4 pari a 3 pg/ml tra il gruppo di studio (terapia con metimazolo + Selenio + colecalciferolo) e quello di controllo (terapia standard) alla visita T2 (fine fase intervento dello studio), ad un livello di significatività alpha=0.05
    -Severità dell’ipertiroidismo a 180 giorni, valutata mediante lo score “Clinical Activity Score”
    -Dose di metimazolo media nei due gruppi
    E.5.1.1Timepoint(s) of evaluation of this end point
    180 days (T2)
    180 giorni (T2)
    E.5.2Secondary end point(s)
    -clinical manifestation of hyperthyroid after 45 and 240 days from baseline
    -thyroid hormone levels (FT4, FT3, TSH) after 45 and 240 days from enrollment
    -severity of Graves' disease assessed by Clinical Severity Score
    assessed after 45 and 240 days from enrolment
    -Glutathione, Malondialdehyde levels baseline, after 180 and 240 days from enrolment
    -Lymphocytes typization for Treg baseline and after 180 days from enrollment
    - Ultrasound thyroid morphology/echogenicity
    -Andamento delle manifestazioni cliniche e biochimiche dell'ipertiroidismo a 45 e a 240 giorni.
    -Severità dell’ipertiroidismo a 45 e a 240 giorni, valutata mediante “Clinical Activity Score”.
    -Andamento dei parametri di stress ossidativo (Glutatione e Malondialdeide) a 180 e 240 giorni rispetto al basale.
    -Andamento della tipizzazione linfocitaria (Treg) con citofluorometria a 180 e a 240 giorni
    -Andamento degli anticorpi circolanti diretti contro antigeni tiroidei a 45, 180 e 240 giorni.
    -Andamento del volume tiroideo, del pattern di ecogenicità e della vascolarizzazione ghiandolare.

    E.5.2.1Timepoint(s) of evaluation of this end point
    day 45 (T0) and day 240 (T3)
    45 (T0) e 240 giorni (T3)
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    gruppo di controllo: terapia standard con metimazolo.
    gruppo di trattamento: terapia standard con m
    control group: standard therapy with methimazole
    treatment group: standard therapy + Selenium + chol
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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 months12
    E.8.9.1In the Member State concerned days36
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months12
    E.8.9.2In all countries concerned by the trial days36
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 60
    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)
    regular follw-up at outpatients clinic of Endocrinology, ASST Sette Laghi Varese
    i soggetti partecipanti allo studio proseguiranno in regolare follow-up come da pratica clinica presso gli ambulatori della SC Endocrinologia ASST Sette Laghi di Varese
    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 Decision2019-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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