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    Summary
    EudraCT Number:2012-005824-13
    Sponsor's Protocol Code Number:MEIN/12/Bil-Ang/001
    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:2013-02-12
    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 number2012-005824-13
    A.3Full title of the trial
    Pilot study on efficacy of bilastine in preventing angioedema symptoms in patients with angioedema of unknown etiology (idiopathic angioedema, IAE)
    Studio pilota sull'efficacia di Bilastina nella prevenzione dei sintomi dell'angioedema in pazienti affetti da angioedema idiopatico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study on efficacy of bilastine in preventing angioedema symptoms in patients with angioedema of unknown etiology (idiopathic angioedema, IAE)
    Studio pilota sull'efficacia di bilastina nella prevenzione dei sintomi dell’ angioedema in pazienti affetti da angioedema con eziologia sconosciuta (angioedema idiopatico, IAE)
    A.3.2Name or abbreviated title of the trial where available
    Light
    Light
    A.4.1Sponsor's protocol code numberMEIN/12/Bil-Ang/001
    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 SponsorMenarini International Operation Luxembourg SA
    B.1.3.4CountryLuxembourg
    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 supportMenarini International Operation Luxembourg SA
    B.4.2CountryLuxembourg
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA. Menarini Industrie Farmaceutiche Riunite S.r.l.
    B.5.2Functional name of contact pointAlessandra Spinali
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Sette Santi, 1/3
    B.5.3.2Town/ cityFirenze
    B.5.3.3Post code50131
    B.5.3.4CountryItaly
    B.5.4Telephone number003905556801
    B.5.5Fax number003905556807662
    B.5.6E-mailASpinali@menarini.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 Yes
    D.2.1.1.1Trade name ROBILAS
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini International Operations Luxembourg SA
    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 nameROBILAS
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product typeBilastine (C28H37N3O3) -20 mg, antihistamine
    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 Yes
    D.2.1.1.1Trade name TRANEX
    D.2.1.1.2Name of the Marketing Authorisation holderMalesci Istituto Farmacologico 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 nameTRANEX
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.13.1Other medicinal product typeTranexamic acid - 500 mg, antifibrinolytic
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    idiopathic angioedema
    Angioedema idiopatico
    E.1.1.1Medical condition in easily understood language
    Angioedema of unknown cause (etiology)
    Angioedema di cui non si conoscono le cause (eziologia)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To assess the efficacy of the antihistamine bilastine compared with placebo in preventing angioedema symptoms evaluated as reduction of the number of days with moderate to severe angioedema in patients with IAE, in comparison to baseline situation.
    Valutare l’efficacia dell’antistaminico bilastina rispetto al placebo nel prevenire i sintomi di angioedema, espressa come riduzione nei confronti del basale, del numero di giorni con angioedema moderato o severo, in pazienti affetti da angiodema idiopatico (IAE)
    E.2.2Secondary objectives of the trial
    1.To assess the proportion of subjects that during the treatment period has a number of days with moderate to severe angioedema ≤ 2 every 8 weeks
    2.To assess the need for therapy of angioedema attacks and the duration of treatment
    3.To assess the safety and tolerability of bilastine compared to placebo.

    1.Valutare la proporzione di soggetti, nei quali, durante il periodo di trattamento, il numero di giorni con angioedema, moderato o severo, si riduce a ≤ 2 giorni ogni 8 settimane
    2.Valutare la necessità di una terapia per gli attacchi di angioedema e la durata del trattamento
    3.Valutare la sicurezza e la tollerabilità di bilastina rispetto al placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subjects must have given a written informed consent
    2.Male or female;
    3.Age ≥ 18 years;
    4.Diagnosis of chronic IAE (according to Kaplan-Greaves 2005 criteria)
    5.Presence of ≥ 4 days of moderate to severe cutaneous or mucosal symptoms of angioedema per 4 weeks, in the last 12 weeks or more
    6.No angioedema symptoms when starting the treatment
    7.C1-inhibitor functional levels ≥ 60% of normal values
    8.Able to complete screening and assessments
    9.Women of childbearing potential must have a negative urine pregnancy test;
    10.Willingness and ability to participate in the study.
    11.No other experimental treatments.
    1.I soggetti devono firmare il consenso informato;
    2.Uomini o donne;
    3.Età ≥ 18 anni;
    4.Diagnosi di angioedema idiopatico cronico (in accordo ai criteri di Kaplan-Graves 2005)
    5.Presenza dei sintomi di angioedema moderato o severo, cutaneo o mucosale per ≥ 4 giorni ogni 4 settimane, da almeno 12 settimane
    6.Nessun sintomo di angiodema all’inizio del trattamento
    7.Livelli funzionali di inibitore C1 ≥ 60% dei valori normali
    8.Capace di effettuare lo screening e le valutazioni previste dallo studio
    9.Le donne in età fertile devono risultare negative al test di gravidanza (test delle urine)
    10.Volontà e disponibilità a partecipare allo studio
    11.Nessun altro trattamento sperimentale in corso
    E.4Principal exclusion criteria
    1.Diagnosis of angioedema of any defined cause: allergic, hereditary/acquired C1-Inhibitor deficiency, ACE (Angiotensin Converting Enzyme) inhibitor or NSAID induced angioedema, drug and/or food/disease induced angioedema (according to Kaplan-Greaves 2005 criteria);
    2.Participation in a clinical trial of another Investigational Product (IP) within the past month;
    3.On treatment with ACE inhibitors or ARB (Angiotensin Receptor Blockers);
    4.Evidence of clinically relevant cardiovascular disease or thrombophylic condition
    5.History of autoimmune disorders, Hodgkin’s disease and any clinically significant condition (neurological, hepatic, renal or malignant diseases) that upon the judgment of the investigator contraindicates participation to the study;
    6.Pregnancy and/or breast-feeding;
    7.Mental condition rendering the subject, in the opinion of the investigator, unable to understand the nature, scope and possible consequences of the study;
    8.Unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason;
    9.Known hypersensitivity to bilastine, its excipients, H1-antihistamines, benzimidazoles
    10.Patient with concomitant drugs as systemic or topical corticosteroids within 4 weeks, astemizole within 6 weeks, ketotifen within 2 weeks, any other systemic antihistamine (including loratadine, desloratadine, ebastine, rupatadine, mizolastine, cetirizine or levocetirizine) within 3 days, anti-leukotrienes within 3 days, sodium cromoglycate or nedocromil within 2 weeks, and tricyclic antidepressants within 1 week of randomization and ace-inibhitors, sartan drugs, cinnarizine, with the exception of the case in which some of them have been used for the symptoms.

    1.Diagnosi di angioedema con una causa definita, ad es. di origine allergica, deficienza del C1 inibitore ereditaria/acquisita, angioedema indotto da inibitori dell’ACE, angioedema causato da farmaci e/o alimenti;
    2.Partecipazione nel mese precedente, ad un altro studio clinico con un altro prodotto in sperimentazione (Prodotto in sperimentazione, IP)
    3.Attualmente in terapia con ACE inibitori o terapia con ARB (farmaci che bloccano i recettori dell’angiotensina)
    4.Evidenza di patologie cardiovascolari o condizioni trombofiliche clinicamente rilevanti
    5.Pazienti con precedenti disordini autoimmunitari, malattia di Hodgkin e qualsiasi condizione clinica significativa (malattie neurologiche, epatiche, renali o neoplasie), che a giudizio dello Sperimentatore possono essere controindicate nella partecipazione allo studio
    6.Gravidanza e/o allattamento
    7.Condizioni mentali che rendono il soggetto, a giudizio dello Sperimentatore, incapace di comprendere la natura, lo scopo e le possibili conseguenze dello studio;
    8.Soggetti che probabilmente non seguirebbero il protocollo, ad esempio che hanno un atteggiamento di scarsa cooperazione, incapacità nel tornare alle visite di follow-up o che probabilmente non completerebbero lo studio per qualsiasi motivo;
    9.Ipersensibilità nota verso la bilastina o i suoi eccipienti, H1 antistaminici, benzimidazolo
    10.Pazienti che assumono farmaci concomitanti, come corticosteroidi sistemici o topici entro 4 settimane, astemizolo entro 6 settimane, ketotifene entro 2 settimane, qualsiasi altro antistaminico sistemico (incluso loratadina, desloratadina, ebastina, rupatadina, mizolastina, cetirizina o levocitirizina) entro 3 settimane, anti-leucotrieni entro 3 giorni, sodio cromoglicato o nedocromile entro 2 settimane, e antidepressivi triciclici entro 1 settimana dalla randomizzazione, ACE inibitori, sartani, cinnarizina, ad eccezione dei casi in cui vengano utilizzati per i sintomi dell’angioedema.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of the antihistamine bilastine compared with placebo in preventing angioedema symptoms evaluated as reduction of the number of days with moderate to severe angioedema in patients with IAE, in comparison to baseline situation.
    Valutare l’efficacia dell’antistaminico bilastina rispetto al placebo nel prevenire i sintomi di angioedema, espressa come riduzione nei confronti del basale, del numero di giorni con angioedema moderato o severo, in pazienti affetti da angiodema idiopatico (IAE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline assessment prior to randomization; final assessment at the end of treatment
    Rilevazione basale prima della randomizzazione; rilevazione finale a fine trattamento
    E.5.2Secondary end point(s)
    1.To assess the proportion of subjects that during the treatment period has a number of days with moderate to severe angioedema ≤ 2 every 8 weeks
    2.To assess the need for therapy of angioedema attacks and the duration of treatment
    3.To assess the safety and tolerability of bilastine compared to placebo.





    1.Valutare la proporzione di soggetti, nei quali, durante il periodo di trattamento, il numero di giorni con angioedema, moderato o severo, si riduce a ≤ 2 giorni ogni 8 settimane
    2.Valutare la necessità di una terapia per gli attacchi di angioedema e la durata del trattamento
    3.Valutare la sicurezza e la tollerabilità di bilastina rispetto al placebo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Randomization visit until 30 days after the end of treatment
    Visita di randomizzazione fino a 30 giorni dopo la fine del trattamento
    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 No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 years
    E.8.9.1In the Member State concerned months18
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 2013-02-12. 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 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)
    The study treatment will be suspended at the end of the patient participation to the trial and they will continue with the therapy already in place or with a different therapy, except to any changes that the study investigator will consider useful to ensure the best control of symptoms.
    Il trattamento in studio sarà sospeso al termine della partecipazione dei soggetti alla Sperimentazione e questi continueranno con la terapia già in atto o con una diversa forma di terapia fatte salve eventuali variazioni che il medico responsabile della Sperimentazione, riterrà utili per garantire il miglior controllo dei sintomi.
    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 Decision2013-03-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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