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    Summary
    EudraCT Number:2012-003677-25
    Sponsor's Protocol Code Number:12I/T405
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-12-28
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2012-003677-25
    A.3Full title of the trial
    Safety and bioavailability of Tirosint
    (Levothyroxine Sodium) Oral Solution
    administered as single dose with or without water
    in hypothyroid patients.
    Tollerabilità e biodisponibilità di Tirosint (levotiroxina sodica)
    soluzione per uso orale somministrata in dose singola con o senza
    acqua a pazienti ipotiroidei.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    safety of the administration of levothyroxine sodium
    oral solution (LT4s) swallowed in fasting conditions with or without
    water in hypothyroid patients
    sicurezza della soluzione di
    levotiroxina dopo somministrazione per via orale di una dose unica
    (100 μg) di LT4 soluzione orale assunta con o senza acqua in condizioni di digiuno da pazienti ipotiroidei
    A.4.1Sponsor's protocol code number12I/T405
    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 SponsorIBSA INSTITUT BIOCHIMIQUE SA
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIBSA INSTITUT BIOCHIMIQUE SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIBSA INSTITUT BIOCHIMIQUE SA
    B.5.2Functional name of contact pointClinical Reserarch Manager
    B.5.3 Address:
    B.5.3.1Street AddressVia del Piano
    B.5.3.2Town/ cityPambio-Noranco
    B.5.3.3Post code6915
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041 58 360 10 00
    B.5.5Fax number0041 58 360 16 55
    B.5.6E-mailsandra.fantoni@ibsa.ch
    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 TIROSINT*OS 30FL 1ML 100MCG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA Srl
    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.3.4Pharmaceutical form Oral solution
    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 INNLEVOTIROXINA
    D.3.9.4EV Substance CodeSUB20658
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Both genders thyroidectomized patients, with thyroglobulin (Tg) circulating levels below 5 ng/mL and no evidence of Tg antibodies (Tg-Ab), at stable (at least 3 months) 100 μg/day levothyroxine tablets therapy
    Saranno selezionati per lo studio pazienti tiroidectomizzati di entrambi i sessi, con valori di tireoglobulina circolante inferiori a 5 ng/ml e anticorpi antitireoglobulina non rilevabili, in terapia stabile da almeno 3 mesi con LT4 compresse alla dose giornaliera di 100 μg.
    E.1.1.1Medical condition in easily understood language
    hypothyroid patients already treated with levothyroxine tablets
    pazienti ipotiroidei già in terapia a dose stabile (100 μg/die) con LT4 compresse,
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021114
    E.1.2Term Hypothyroidism
    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 evaluate the absorption pattern of LT4, on the basis of circulating total T4 (TT4), in hypothyroid patients already treated with levothyroxine tablets, following the administration of levothyroxine sodium oral solution (LT4s) swallowed in fasting conditions with or without water.
    Verificare il profilo di assorbimento della LT4 sulla base dei livelli sierici di T4 totale (TT4), in pazienti ipotiroidei già in trattamento con LT4 compresse, a seguito della somministrazione di una dose unica per via orale di LT4 soluzione assunta con o senza acqua in condizioni di digiuno.
    E.2.2Secondary objectives of the trial
    To confirm the clinical safety (in terms of vital signs, ECG, adverse events) of the LT4 solution in both administration conditions; to verify the acceptability of the LT4 solution in both administration conditions.
    Confermare la tollerabilità clinica (segni vitali, ECG, eventi avversi) di entrambe le modalità di somministrazione; verificare il gradimento delle due modalità di somministrazione.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • written informed consent; • hypothyroid patients of both genders, thyroidectomized in consequence of thyroid cancer or other thyroid diseases; • ≥18 and ≤75 years of age; • Body Mass Index (BMI) > 18.5 and < 32.0 kg/m2 • Tg levels < 5 ng/mL; • nondetectable (<30 IU/mL) anti-thyroglobulin antibodies (Tg- Ab); • substitutive and/or TSH suppressive treatment with LT4 tablets at a stable (at least three months) dosage (100 μg/day); • serum FT4, FT3 and TSH within normal values for the patient; • availability and possibility of taking part in the study; • reasonable assumption of understanding the study and of reliability.
    • consenso informato scritto; • pazienti ipotiroidei di entrambi i sessi tiroidectomizzati (in conseguenza di patologie neoplastiche o altre affezioni tiroidee); • età compresa tra i 18 ed i 75 anni; • Indice di Massa Corporea (Body Mass Index: BMI) superiore a 18.5 e inferiore a 32.0 kg/m2 • Tireoglobulina circolante &lt; 5 ng/mL; • anticorpi antitireoglobulina non rilevabili (&lt;30 IU/mL); • terapia sostitutiva/TSH soppressiva con LT4 compresse a dosaggio (100 μg/die) stabile da almeno tre mesi; • valori sierici di FT4, FT3 e TSH entro valori normali per il singolo paziente (i.e. non necessità di variazioni posologiche); • disponibilità e possibilità di partecipazione allo studio; • ragionevole ipotesi di capacità di comprensione degli scopi e delle modalità dello studio, nonchè di affidabilità.
    E.4Principal exclusion criteria
    seriously compromised cardiac (heart failure), hepatic, renal and/or respiratory functions; • active arrhythmia or history of arrhythmia, particularly atrial fibrillation • serious metabolic (e.g. uncompensated diabetes mellitus), organs (e.g. cirrhosis of the liver), endocrine or systemic diseases (excluding the basic pathology); • epilepsy; • neoplastic pathology, active or in remission for less than 5 years (excluding the basic thyroid pathology); • terminal condition; • parenteral or assisted enteral feeding;clinically significant illness or surgery within 4 weeks prior to dosing; • presence of any medical condition or other circumstances which would significantly decrease the chance of obtaining reliable data, achieving study objectives or completing the study; • serious psychiatric problems (whether or not receiving treatment) or in any case such as to compromise the patient’s reliability; • non-therapeutic use of psychotropic substances; • alcoholism; • positive test for hepatitis B, hepatitis C, or HIV at screening; • positive pregnancy test; • breast-feeding; • known hypersensitivity to the ingredients of the preparation involved in the study; • use of concomitant medications that might interfere with study evaluations; • regular consumption of soya and soya derivatives • skin lesions at the site of the blood sampling (forearm); • difficult access to the peripheral venous blood vessels; • emesis episode within 24 hours prior to dosing; • participation in other clinical studies during the two months prior to dosing; • donation of blood during the two months prior to dosing; • presumption of poor reliability/cooperation; • any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
    • grave compromissione delle funzioni cardiaca, respiratoria, epatica e/o renale; • presenza di aritmia o storia di aritmia, in particolare fibrillazione atriale; • gravi malattie metaboliche (ad esempio diabete mellito scopensato), d’organo (es. cirrosi epatica), endocrine (esclusa la patologia tiroidea di base) o sistemiche; • epilessia; • patologie neoplastiche in atto o in remissione da meno di 5 anni (esclusa la patologia tiroidea di base); • stato terminale; • alimentazione parenterale o assistita; • significative malattie o procedure chirurgiche entro le 4 settimane prima dei trattamenti sperimentali; • presenza di ogni condizione, medica o di altro tipo, che potrbbe ridurre in maniera significativa la possibilità di ottenere dati affidabili, di raggiungere gli scopi dello studio e/o di completare il medesimo; • patologie psichiatriche serie (in trattamento o meno) o in ogni caso di natura tale da compromettere l’affidabilità del soggetto; • uso non terapeutico di sostanze psicoattive; • alcoolismo; • positività dei tests per epatite B/epatite C/infezione da HIV agli accertamenti di screening; • positività del test di gravidanza; • allattamento al seno; • ipersensibilità nota ai componenti della soluzione oggetto di studio; • uso concomitante di farmaci o sostanze potenzialmente in grado di interferire con i parametri di valutazione; • uso regolare di soia e suoi derivati • lesioni cutanee nella sede dei prelievi ematici; • accesso difficoltoso all rete venosa superficiale; • episodi di emesi nelle 24 ore antecedenti l’inizio dello studio; • partecipazione ad altri studi clinici nei due mesi antecedenti lo studio; • donazioni di sangue nei due mesi antecedenti lo studio; • presunzione di scarsa affidabilità/cooperazione; • ogni elemento che, a giudizio dello Sperimentatore, rappresenti una controindicazione alla partecipazione allo studio da parte del paziente.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the absorption pattern of LT4, on the basis of circulating total T4 (TT4), in hypothyroid patients already treated with levothyroxine tablets, following the administration of levothyroxine sodium oral solution (LT4s) swallowed in fasting conditions with or without water.
    Verificare il profilo di assorbimento della LT4 sulla base dei livelli sierici di T4 totale (TT4), in pazienti ipotiroidei già in trattamento con LT4 compresse, a seguito della somministrazione di una dose unica per via orale di LT4 soluzione assunta con o senza acqua in condizioni di digiuno.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples: -0.1 hours (= 6 minutes) pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 24 hours post-dose
    Campioni di sangue: -0.1 hours (= 6 minutes) pre-dose, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, and 24 hours post-dose
    E.5.2Secondary end point(s)
    To confirm the clinical safety (in terms of vital signs, ECG, adverse events) of the LT4 solution in both administration conditions; to verify the acceptability of the LT4 solution in both administration conditions.
    Confermare la tollerabilità clinica (segni vitali, ECG, eventi avversi) di entrambe le modalità di somministrazione; verificare il gradimento delle due modalità di somministrazione
    E.5.2.1Timepoint(s) of evaluation of this end point
    pre-dose and and 24 hours post-dose
    Prima della somministarzione e 24 ore dopo la somministrazione.
    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 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 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
    soluzione di LT4 somministrata con acqua [LT4sw] 
    LT4 solution administered with water [LT4sw] LT4
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    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.8.6 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 years0
    E.8.9.1In the Member State concerned months12
    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 months12
    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.1.1Number of subjects for this age range: 0
    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: 24
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 2012-12-28. 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 state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 24
    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)
    Safety will be checked by medical visit 10-15 days after IMO administration
    Un controllo con visita medica di sicurezza sarà effettuata dopo 10-15 giorni dall'ultimo trattamento.
    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 Decision2013-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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