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    Summary
    EudraCT Number:2013-002188-24
    Sponsor's Protocol Code Number:2013-002188-24
    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:2013-10-28
    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 number2013-002188-24
    A.3Full title of the trial
    REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA WITH CHOLECALCIFEROL 200,000 IU OS ADMINISTERED FOR ONE MONTH BEFORE SURGERY
    RIDUZIONE DELLA IPOCALCEMIA TRANSITORIA POST-TIROIDECTOMIA CON COLECALCIFEROLO 200.000 UI PER OS SOMMINISTRATE UN MESE PRIMA DELL’ INTERVENTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA WITH VITAMIN D ADMINISTERED FOR ONE MONTH BEFORE SURGERY
    RIDUZIONE DELLA IPOCALCEMIA TRANSITORIA POST-TIROIDECTOMIA CON VITAMINA D PER OS SOMMINISTRATE UN MESE PRIMA DELL’ INTERVENTO
    A.3.2Name or abbreviated title of the trial where available
    REDUCTION OF POST-THYROIDECTOMY TRANSIENT HYPOCALCEMIA
    RIDUZIONE DELLA IPOCALCEMIA TRANSITORIA POST-TIROIDECTOMIA
    A.4.1Sponsor's protocol code number2013-002188-24
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 25.000 ui
    D.2.1.1.2Name of the Marketing Authorisation holderAbiogen Pharma spa
    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 25.000 UI
    D.3.2Product code A11CC05
    D.3.4Pharmaceutical form Oral liquid
    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 INNcolecalciferol
    D.3.9.1CAS number 67-97-0
    D.3.9.2Current sponsor codeA11CC05
    D.3.9.3Other descriptive nameCHOLECALCIFEROL
    D.3.9.4EV Substance CodeSUB34314
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number200.000
    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
    Background: 30% of patients undergoing surgery for total thyroidectomy in the first 24 hours may experience a transient hypocalcaemia (serum calcium <8 mg / dl). According to recent studies, pre-surgery serum levels of vitamin D appear to predict the transient hypocalcemia, and those most at risk would be those with vitamin D insufficiency .
    Background: Nel 30% dei pazienti sottoposti all’intervento di tiroidectomia totale nelle prime 24 si riscontra una ipocalcemia transitoria (calcemia < 8 mg/dl). Secondo recenti studi i livelli sierici di vitamina D pre-intervento sembrano predire l’ipocalcemia transitoria, i soggetti più a rischio sarebbero quelli con insufficienza vitaminica D
    E.1.1.1Medical condition in easily understood language
    transient hypocalcaemia (serum calcium <8 mg / dl) post thyroidectomy .
    l’ipocalcemia transitoria ( calcemia<8 mg/dl) post tiroidectomia.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10006975
    E.1.2Term Calcium metabolism disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10013296
    E.1.2Term Bone, calcium, magnesium and phosphorus metabolism disorders
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10020949
    E.1.2Term Hypocalcemia
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of the study: administer to patients candidates for thyroidectomy for multinodular goiter cholecalciferol 50,000 IU per os a week, for 4 weeks before surgery, to achieve sufficient vitamin D levels and reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%).

    Scopo del lavoro: supplementare i pazienti candidati all’intervento di tiroidectomia per gozzo multinodulare con colecalciferolo 50.000 ui per os a settimana, per 4 settimane prima dell’intervento, per raggiungere la sufficienza vitaminica e ridurre il rischio di ipocalcemie transitorie di almeno il 50% del valore atteso (power 80%).
    E.2.2Secondary objectives of the trial
    not applicable
    non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female ( age range 40-60 years)
    • candidates for total thyroidectomy for multinodular goiter according to current guidelines
    • maschi e femmine di eta’ compresa tra i 40-60 anni
    • candidati ad intervento di tiroidectomia totale per gozzo multinodulare secondo le attuali linee guida
    E.4Principal exclusion criteria
    • Prengnancy
    • Cancer
    • Creatinine Clearance <60 ml/min
    • Medications that interfere with the metabolism of calcium lithium, estrogen, anticonvulsants, corticosteroids, thiazide diuretics, bisphosphonates, calcium and vitamin D in the three months prior to enrollment)
    • Patients with previous parathyroidectomy
    • Gravidanza in atto
    • Neoplasie
    • Clearance della creatinina <60 ml/min
    • Assunzione di farmaci che interferiscono con il metabolismo calcio fosforico (litio, estrogeni, antiepilettici, cortisonici, diuretici tiazidici, bisfosfonati, calcio e vitamina D nei tre mesi precedenti all’arruolamento)
    • Pazienti con precedenti interventi di paratiroidectomia
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point: reduce the risk of transient hypocalcemias of at least 50% of the expected value (power 80%).The sample will be randomized at enrollment: 120 patients will receive oral cholecalciferol 50,000 IU per week for 4 weeks before surgery, 120 patients will have no treatment (4). The cholecalciferol will be free provided to patients from Abiogen Pharma spa. Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia.
    Methods: The following parameters will be measured in the Policlinico Umberto I, at enrollment, and two days before the surgery:
    • Total calcium
    • Ionized calcium
    • Phosphorus
    • 25(OH) vitamin D
    • Parathyroid hormone
    After 24 hours and 6 months from surgery:
    • Ionized calcium
    • Parathyroid hormone
    End point primario: ridurre il rischio di ipocalcemie transitorie di almeno il 50% del valore atteso (power 80%).Il campione sarà randomizzato all’arruolamento: 120 pazienti riceveranno colecalciferolo 50.000 ui per os a settimana per 4 settimane prima dell’intervento, 120 pazienti non avranno alcun trattamento (4). Il colecalciferolo verrà fornito gratuitamente ai pazienti dalla Abiogen Pharma spa. Due giorni prima dell’ intervento verranno rivalutati gli stessi parametri ematochimici dosati all’arruolamento. Dopo 24 ore dall’intervento sarà valutata l’incidenza di ipocalcemia mediante valutazione biochimica. Dopo 6 mesi dall’intervento mediante contatto telefonico verrà invitato il paziente a rivalutare l’eventuale persistenza di ipocalcemia.
    Metodi: Verranno dosati, presso il laboratorio del Policlinico Umberto I, all’arruolamento e due giorni prima dell’intervento:
    • calcio totale
    • calcio ionizzato
    • fosforo
    • 25(OH)vitamina D
    • paratormone
    Dopo 24 ore e a 6 mesi dall’intervento:
    • calcio ionizzato
    • paratormone
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two days before the operation will be re-evaluated the same parameters measured at enrollment. After 24 hours of surgery the incidence of hypocalcemia will be evaluated biochemically. 6 months after surgery through telephone contact, the patient will be asked to re-evaluate the possible persistence of hypocalcemia.
    Due giorni prima dell’ intervento verranno rivalutati gli stessi parametri ematochimici dosati all’arruolamento. Dopo 24 ore dall’intervento sarà valutata l’incidenza di ipocalcemia mediante valutazione biochimica. Dopo 6 mesi dall’intervento mediante contatto telefonico verrà invitato il paziente a rivalutare l’eventuale persistenza di ipocalcemia.
    E.5.2Secondary end point(s)
    no
    no
    E.5.2.1Timepoint(s) of evaluation of this end point
    no
    no
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    nessun trattamento
    no treatment
    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
    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 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: 240
    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 state240
    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 if patients had no hypoclcemia. If hypocalcemia occured drugs used in this clinical settings it will provided following current guidelines
    nessuno se il paz. non ha avuto una ipocalcemia. qualora si verificasse verrà trattato secondo le linee guida attuali
    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 Decision2014-01-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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