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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:2017-001760-38
    Sponsor's Protocol Code Number:T4drops-02
    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:2017-06-16
    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 number2017-001760-38
    A.3Full title of the trial
    Clinical study of the efficacy of liquid (drops) versus classic (tablets) formulations of levothyroxine in replacement therapy of adults with clinical hypothyroidism.
    Μελέτη της αποτελεσματικότητας της θεραπείας υποκατάστασης με λεβοθυροξίνη σε υγρή μορφή (σταγόνες) έναντι της κλασσικής μορφής (δισκίων) στην αντιμετώπιση ασθενών με κλινικό μόνιμο 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.4.1Sponsor's protocol code numberT4drops-02
    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 Kleon Tsetis Pharmaceutical Laboratories S.A.
    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 Kleon Tsetis Pharmaceutical Laboratories S.A.
    B.4.2CountryGreece
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.
    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-mailsoumelas@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 Kleon Tsetis Pharmaceutical Laboratories S.A.
    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 adults
    Υποθυρεοειδισμός σε ενήλικες
    E.1.1.1Medical condition in easily understood language
    Replacement of natural thyroid hormones, when thyroid gland does not produce enough
    Υποκατάσταση των ορμονών του θυρεοειδούς, 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 20.0
    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
    Scope of the present study is to investigate whether there is equivalent efficacy between replacement therapy of a new LT4 formulation in liquid form (oral drops) versus the classic form (tablets) in adult patients with clinical permanent hypothyroidism.
    Σκοπός της παρούσας μελέτης είναι να διερευνηθεί αν υπάρχει ισοδύναμη αποτελεσματικότητα μεταξύ της θεραπείας υποκατάστασης ενός νέου σκευάσματος LT4 σε υγρή μορφή (σταγόνες) έναντι της κλασικής μορφής (δισκία), σε ενήλικες ασθενείς με κλινικό μόνιμο υποθυρεοειδισμό.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written consent of patients
    2. Patients of both genders
    3. Patients with established clinical permanent hypothyroidism (TSH value > 10μU / mL & FT4 < 0.8ng / dL)
    4. Aged 20-60 years old
    5. Patients already on replacement therapy with LT4 tablets
    1. Έγγραφη συγκατάθεση των ασθενών
    2. Ασθενείς και των δύο φύλων
    3. Ασθενείς με διαγνωσμένο κλινικό μόνιμο υποθυρεοειδισμό (διαπιστωμένη τιμή TSH > 10μU/mL& FT4 < 0.8ng/dL)
    4. Ηλικία 20-60 ετών
    5. Ασθενείς οι οποίοι ήδη λαμβάνουν θεραπεία υποκατάστασης με σκεύασμα LT4
    E.4Principal exclusion criteria
    1. Co-existence of any cardiovascular diseases (arrhythmias, coronary disease etc)
    2. Patients with gastrointestinal disorders that prevent the absorption of LT4 (celiac disease, Helicobacter pylori and atrophic gastritis)
    3. Co-administration of drugs interfering with the absorption or metabolism of LT4
    4. Patients with thyroid cancer
    5. Pregnancy
    1. Ασθενείς με κάθε είδους καρδιοπάθεια (αρρυθμία, στεφανιαία νόσο κ.λ.π.)
    2. Ασθενείς με γαστρεντερικές διαταραχές που εμποδίζουν την απορρόφηση της LT4 (κοιλιοκάκη, Helicobacter Pylori, ατροφική γαστρίτιδα)
    3. Ασθενείς που λαμβάνουν φαρμακευτικά σκευάσματα που παρεμβαίνουν στην απορρόφηση ή το μεταβολισμό της LT4
    4. Ασθενείς με καρκίνο του θυρεοειδούς
    5. Έγκυες γυναίκες
    E.5 End points
    E.5.1Primary end point(s)
    To compare the efficacy of a new LT4 formulation in liquid form (T4® oral drops, solution 100μg / ml) versus the classic form (T4® Tablets) in adult patients with clinical permanent hypothyroidism. The aim is to demonstrate that concentrations of FT4 and TSH do not have a statistically significant difference.
    Η σύγκριση της αποτελεσματικότητας ενός νέου σκευάσματος LT4 σε υγρή μορφή (T4® Πόσιμες σταγόνες, διάλυμα 100μg/ml) έναντι της κλασικής μορφής (T4® Δισκία) σε ενήλικες ασθενείς με κλινικό μόνιμο υποθυρεοειδισμό. Στόχος είναι οι συγκεντρώσεις των FT4 και TSH να μην έχουν στατιστικώς σημαντική διαφορά.
    E.5.1.1Timepoint(s) of evaluation of this end point
    20±4 weeks from the inclusion of the last patient in the study (plus 10 ±2 weeks in case of 4th visit)
    20±4 εβδομάδες από την ένταξη του τελευταίου ασθενούς στη μελέτη (με επιπλέον 10 ±2 εβδομάδες στην περίπτωση 4ης επίσκεψης)
    E.5.2Secondary end point(s)
    Not applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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 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) 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    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 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: 50
    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 state50
    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 Decision2017-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-01
    P. End of Trial
    P.End of Trial StatusCompleted
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