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    The EU Clinical Trials Register currently displays   44201   clinical trials with a EudraCT protocol, of which   7332   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-002462-24
    Sponsor's Protocol Code Number:T4drops-01
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-11-13
    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 ConcernedGreece - EOF
    A.2EudraCT number2015-002462-24
    A.3Full title of the trial
    Clinical study of the efficacy of liquid (drops) versus classic (tablets) formulations of Levothyroxine in replacement therapy of congenital hypothyroidism in infancy and childhood
    Μελέτη της αποτελεσματικότητας της θεραπείας υποκατάστασης με θυροξίνη σε υγρή μορφή (σταγόνες) έναντι της κλασικής μορφής (δισκίων) στην αντιμετώπιση νηπίων και παιδιών με Συγγενή Υποθυρεοειδισμό
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the efficacy of levothyroxine preparations in tablet form and liquid form (drops)
    Σύγκριση αποτελεσματικότητας σκευασμάτων θυροξίνης σε μορφή δισκίων και σε υγρή μορφή (σταγόνες)
    A.3.2Name or abbreviated title of the trial where available
    UPH-T4DROPS-2015-01
    A.4.1Sponsor's protocol code numberT4drops-01
    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 SponsorUNI-PHARMA SA
    B.1.3.4CountryGreece
    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 supportUNI-PHARMA SA
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUni-Pharma SA
    B.5.2Functional name of contact pointRegulatory Affairs department
    B.5.3 Address:
    B.5.3.1Street Address14th Km National Road 1
    B.5.3.2Town/ cityKifissia/Athens
    B.5.3.3Post code14564
    B.5.3.4CountryGreece
    B.5.4Telephone number302108072512374
    B.5.5Fax number302108078907
    B.5.6E-mailunipharma@uni-pharma.gr
    D. IMP Identification
    D.IMP: 1
    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 T4 tablets, any strength
    D.2.1.1.2Name of the Marketing Authorisation holderUNI-PHARMA SA
    D.2.1.2Country which granted the Marketing AuthorisationGreece
    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 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 INNLEVOTHYROXINE SODIUM
    D.3.9.1CAS number 55-03-8
    D.3.9.4EV Substance CodeSUB08495MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12 to 200
    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 No
    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 nameT4 Oral drops, solution 100 μg/ml
    D.3.4Pharmaceutical form Oral drops, solution
    D.3.4.1Specific paediatric formulation Yes
    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 INNLEVOTHYROXINE SODIUM
    D.3.9.1CAS number 55-03-8
    D.3.9.4EV Substance CodeSUB08495MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    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
    Hypothyroidism in children.
    Υποθυρεοειδισμός σε παιδιατρικούς ασθενείς.
    E.1.1.1Medical condition in easily understood language
    Replacement of natural thyroid hormones in children, when thyroid gland does not produce enough.
    Υποκατάσταση των ορμονών του θυρεοειδούς σε παιδιά, όταν ο θυρεοειδής αδένας δεν παράγει αρκετές.
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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 compare the efficacy of a new levothyroxine liquid formulation (T4® Oral drops, solution 100 ug / ml) versus the classic form (T4® Tablets) in infants and children who suffer from congenital hypothyroidism, during the study. The aim is to avoid a statistical difference between the results of hormonal measurements to the respective intervals between the two groups.
    Η σύγκριση της αποτελεσματικότητας ενός νέου σκευάσματος θυροξίνης σε υγρή μορφή (T4® Πόσιμες σταγόνες, διάλυμα 100μg/ml) έναντι της κλασικής μορφής (T4® Δισκία) σε νήπια και παιδιά που πάσχουν από Συγγενή Υποθυρεοειδισμό, κατά τη διάρκεια της μελέτης. Στόχος είναι να μην προκύψει στατιστική διαφορά των αποτελεσμάτων των ορμονολογικών μετρήσεων στις αντίστοιχες χρονικές στιγμές μεταξύ των δύο ομάδων.
    E.2.2Secondary objectives of the trial
    • Measurement of the percentage of patients who had to increase or reduce the dose when changing from tablets to liquid form.
    • Comparison of the study groups regarding the patients who had to increase or reduce the dose during treatment.
    • Μέτρηση του ποσοστού των ασθενών στους οποίους χρειάστηκε να γίνει αύξηση ή μείωση της δόσης κατά την αντικατάσταση από τα δισκία στην υγρή μορφή.
    • Σύγκριση των ομάδων μελέτης όσον αφορά τους ασθενείς στους οποίους χρειάστηκε να γίνει αύξηση ή μείωση της δόσης κατά τη διάρκεια της θεραπείας.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written parental informed consent.
    2. Patients of both genders.
    3. Patients with similar age and parents with similar socio-economic level so as the level of understanding before the consent to be the same.
    4. Age of 4-8 years old.
    5. Patients with diagnosed congenital hypothyroidism.
    6. Patients already on replacement therapy with T4® Tablets.
    7. TSH values 0.5-5 μU/mL.
    1. Έγγραφη συγκατάθεση από τους γονείς.
    2. Ασθενείς και των δύο φύλων.
    3. Ασθενείς με ανάλογη ηλικία και γονείς με ανάλογο κοινωνικο-οικονομικό επίπεδο ώστε το επίπεδο κατανόησης της μελέτης πριν τη συγκατάθεση να είναι το ίδιο.
    4. Ηλικία 4-8 ετών.
    5. Ασθενείς με διαγνωσμένο συγγενή υποθυρεοειδισμό.
    6. Ασθενείς οι οποίοι ήδη λαμβάνουν θεραπεία υποκατάστασης με σκεύασμα T4® Δισκία.
    7. Τιμές TSH 0,5-5 μU/mL.
    E.4Principal exclusion criteria
    1. Age less than 4 years, or more than 8 years.
    2. Absence of a written consent from parents.
    3. New patients not already receiving replacement therapy.
    4. Patients not controlled regarding thyroid hormones.
    5. TSH values off limits 0.5-5 μU / mL.
    6. Patients receiving as replacement therapy a formulation other than T4® Tablets.
    7. Insufficient compliance in patients already receiving replacement therapy, as evidenced by TSH values greater than 5 μU / mL.
    8. Hyperthyroidism of any etiology.
    9. Co-occurring cardiovascular diseases or other chronic diseases or syndromes.
    10. Patients with adrenal insufficiency.
    1. Ηλικία μικρότερη από 4 έτη ή μεγαλύτερη από 8 έτη.
    2. Απουσία έγγραφης συγκατάθεσης από γονείς.
    3. Νέοι ασθενείς που δε λαμβάνουν ήδη θεραπεία υποκατάστασης.
    4. Ασθενείς μη ρυθμισμένοι όσον αφορά τις ορμόνες του θυρεοειδούς.
    5. Τιμές TSH εκτός ορίων 0,5-5 μU/mL.
    6. Ασθενείς οι οποίοι λαμβάνουν θεραπεία υποκατάστασης με σκεύασμα διαφορετικό εκτός των T4® Δισκίων.
    7. Ανεπαρκής συμμόρφωση σε ασθενείς που ήδη λαμβάνουν θεραπεία υποκατάστασης, όπως προκύπτει από τιμές TSH άνω των 5 μU/mL.
    8. Υπερθυρεοειδισμός οποιασδήποτε αιτιολογίας.
    9. Συνυπάρχοντα καρδιαγγειακά νοσήματα ή άλλες χρόνιες νόσοι ή σύνδρομα.
    10. Ασθενείς με επινεφριδιακή ανεπάρκεια.
    E.5 End points
    E.5.1Primary end point(s)
    To compare during the study the efficacy of a new levothyroxine liquid formulation (T4® Oral drops, solution 100μg/ml) versus the classic form (T4® Tablets) in infants and children with congenital hypothyroidism.
    Η σύγκριση της αποτελεσματικότητας ενός νέου σκευάσματος θυροξίνης σε υγρή μορφή (T4® Πόσιμες σταγόνες, διάλυμα 100μg/ml) έναντι της κλασικής μορφής (T4® Δισκία) σε νήπια και παιδιά που πάσχουν από Συγγενή Υποθυρεοειδισμό, κατά τη διάρκεια της μελέτης.
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from the inclusion of the last patient in the study
    6 μήνες από την ένταξη του τελευταίου ασθενούς στη μελέτη
    E.5.2Secondary end point(s)
    • Measurement of the percentage of patients who had to increase or reduce the dose when changing from tablets to liquid form.
    • Comparison of the study groups regarding the patients who had to increase or reduce the dose during treatment.
    • Μέτρηση του ποσοστού των ασθενών στους οποίους χρειάστηκε να γίνει αύξηση ή μείωση της δόσης κατά την αντικατάσταση από τα δισκία στην υγρή μορφή.
    • Σύγκριση των ομάδων μελέτης όσον αφορά τους ασθενείς στους οποίους χρειάστηκε να γίνει αύξηση ή μείωση της δόσης κατά τη διάρκεια της θεραπείας.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 months from the inclusion of the last patient in the study
    6 μήνες από την ένταξη του τελευταίου ασθενούς στη μελέτη
    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 Yes
    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) Yes
    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 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) Yes
    E.8.2.2Placebo No
    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
    LVLS-Participation of 100 patients
    LVLS-Με την εισαγωγή 100 ασθενών
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pediatric patients
    Παιδιατρικοί ασθενείς
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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
    Ουδέν
    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 Decision2015-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-12
    P. End of Trial
    P.End of Trial StatusCompleted
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