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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   41232   clinical trials with a EudraCT protocol, of which   6757   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    Summary
    EudraCT Number:2014-002465-30
    Sponsor's Protocol Code Number:EE-01bude2014
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2014-06-24
    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 number2014-002465-30
    A.3Full title of the trial
    Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.
    Studio spontaneo di fase II sull’efficacia e sicurezza della Budesonide viscosa per via orale, in pazienti pediatrici con Esofagite Eosinofila
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis.
    Studio spontaneo di fase II sull’efficacia e sicurezza della Budesonide viscosa per via orale, in pazienti pediatrici con Esofagite Eosinofila
    A.4.1Sponsor's protocol code numberEE-01bude2014
    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 SponsorDip. Pediatria UOC Gastroenterologia ed Epatologia Pediatrica
    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 supportItalchimici SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDip. Pediatria
    B.5.2Functional name of contact pointUOC Gastroenterologia ed Epatologia
    B.5.3 Address:
    B.5.3.1Street AddressViale Regina Elena, 324
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00161
    B.5.3.4CountryItaly
    B.5.4Telephone number00390649979326
    B.5.5Fax number00390649979325
    B.5.6E-mailsalvatore.cucchiara@uniroma1.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 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 nameBudesonide
    D.3.2Product code Budesonide
    D.3.4Pharmaceutical form Oral suspension
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.19 to 0.21
    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
    Eosinophilic Esophagitis
    Esofagite Eosinofila
    E.1.1.1Medical condition in easily understood language
    Eosinophilic Esophagitis
    Esofagite Eosinofila
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    evaluate the efficacy of budesoniode treatment, a viscous oral suspension, in patiens affected with Eosinophilic Esophagitis, in whom other type of therapies have failed or patients with relapse, or newly diagnosed patients. Evaluate treatment safety in terms of adverse reactions or impact on the cortical-adrenal activity.
    Valutare l'efficacia del trattamento con Budesonide,una sospensione orale viscosa, in pazienti affetti da Esofagite Eosinofila, nei quali altri tipi di terapie hanno fallito o pazienti con recidiva, o pazienti di primo accertamento. Valutare lasicurezza del trattamento in termini di reazioni avverse o di impatto sull'attività cortico-surrenalica
    E.2.2Secondary objectives of the trial
    Not Applicable
    Non Applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    patients of both gender aged below 18 yrs with diagnosis of eosinophilic esophagitis verified by histological examination of esophageal biopsies (eosinophil count >/= 15/HPF)
    Newly diagnosed patients or previously put under restricted diet or treated with fluticasone/budesonide nebulizer suspension with negative results or relapse.
    pazienti di ambo i sessi con età ≤ 18 anni con diagnosi di esofagite eosinofila accertata con EGDS ed esame istologico delle biopsie esofagee (eosinofili ≥15/HPF)
    pazienti di nuova osservazione o precedentemente trattati con regime dietetico o con fluticasone/budesonide spray/sospensione per nebulizzazione con esiti negativi o in recidiva
    E.4Principal exclusion criteria
    Age > 18 yrs
    Patients with concomitant crhonic intestinal pathologies, heart or gut, respiratory or kidney malformations , neurological deficit, uncertain diagnosis of Eosinophilic Esophagitis
    età ≥ 18 anni
    pazienti con concomitanti patologie croniche intestinali ed extraintestinali, malformazioni cardiache o dell’apparato gastrointestinale, respiratorio o renale, deficit neurologici, diagnosi incerta di Esofagite Eosinofila
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of eosinophilic infiltration, evaluated by biopsy at 0, 12 and 36 (follow-up) weeks.
    Riduzione infiltrazione Eosinofila, valutata al basale e alle settimane 12 e 36(follow-up) mediante biopsia
    E.5.1.1Timepoint(s) of evaluation of this end point
    0, 12 and 36 (follow-up) week
    0, 12 e 36 (follow-up) settimane
    E.5.2Secondary end point(s)
    Not Applicable
    Non Applicabile
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    Non Applicabile
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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
    Ultima visita dell'ultimo paziente
    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 months6
    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 Yes
    F.1.1Number of subjects for this age range: 30
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 20
    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 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 2014-06-24. 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 state30
    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)
    Usual clinical practice will be applied
    I pazienti saranno seguiti dal centro secondo pratica clinica
    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 Decision2014-08-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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