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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   41189   clinical trials with a EudraCT protocol, of which   6743   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) .
     
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    Summary
    EudraCT Number:2014-001484-12
    Sponsor's Protocol Code Number:BUL-1/EEA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-10
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001484-12
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis
    Ensayo doble ciego, aleatorizado, controlado con placebo y de fase III sobre la eficacia y la tolerabilidad de un tratamiento de 6 semanas con comprimidos efervescentes de budesonida frente al placebo para la inducción de remisión clinicopatológica en pacientes adultos con esofagitis eosinofílica activa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis
    Ensayo doble ciego (ni el medico ni el paciente saben cual es el tratamiento) , aleatorizado (el paciente será asignado al grupo de tratamiento al azar), controlado con placebo (sustancia inactiva) y de fase III sobre la eficacia y la tolerabilidad de un tratamiento de 6 semanas con comprimidos efervescentes de budesonida frente al placebo para la inducción de remisión clinicopatológica en pacientes adultos con esofagitis eosinofílica activa
    A.3.2Name or abbreviated title of the trial where available
    Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis
    Induccion a la remision con budesonida vs placebo en esofagitis eosinofílica activa
    A.4.1Sponsor's protocol code numberBUL-1/EEA
    A.5.4Other Identifiers
    Name:EOS-1Number:Acronym
    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 SponsorDr. Falk Pharma GmbH
    B.1.3.4CountryGermany
    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 supportDr. Falk Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street AddressC/ Rufino González 14, Esc.1ª-2ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+349134756930
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.com
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/13/1181
    D.3 Description of the IMP
    D.3.1Product name1 mg budesonide effervescent tablet for orodispersible use
    D.3.2Product code BUET 1mg
    D.3.4Pharmaceutical form Effervescent 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 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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOrodispersible tablet
    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
    Active eosinophilic esophagitis
    Esofagitis eosinofilica activa
    E.1.1.1Medical condition in easily understood language
    Chronic allergic/immune-mediated inflammatory disease of the gullet in its active phase
    Enfermedad alérgica/ inmune inflamatoria del esófago en fase activa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10064220
    E.1.2Term Eosinophilic esophagitis
    E.1.2System Organ Class 100000004856
    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 budesonide effervescent tablets vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).
    Evaluar la eficacia de comprimidos efervescentes de budesonida frente a placebo para la inducción de remisión clinicopatológica en pacientes adultos con esofagitis eosinofílica (EE) activa
    E.2.2Secondary objectives of the trial
    -To study safety and tolerability in the form of adverse events and laboratory parameters,
    -To assess patients quality of life.
    Exploratory:
    -To study biomarkers in EoE.
    -Estudiar la seguridad y la tolerabilidad en forma de acontecimientos adversos y parámetros analíticos.
    -Evaluar la calidad de vida del paciente
    -Estudiar los biomarcadores de la EE.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed informed consent,
    - Male or female patients, 18 to 75 years of age,
    - Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria ,
    - Active symptomatic and histological EoE,
    - A documented trial with proton pump inhibitors (PPIs) in order to rule out PPI-responsive esophageal eosinophilia,
    - Negative pregnancy test in females of childbearing potential at baseline visit
    -Firma del consentimiento informado.
    -Pacientes varones o mujeres de 18 a 75 años, ambos inclusive.
    -Diagnóstico clinicopatológico confirmado de EE según los criterios diagnósticos establecidos
    -EEA sintomática e histológica activa
    -Un ensayo documentado con inhibidores de la bomba de protones (IBP) para descartar eosinofilia esofágica sensible a los IBP
    -Prueba de embarazo negativa en mujeres en edad fértil en la visita inicial.
    E.4Principal exclusion criteria
    - Clinical signs (i.e., acid regurgitation and/or heart burn) and endoscopic signs (at least Los Angeles Classification of Esophagitis Grade A) of gastroesophageal reflux disease (GERD),
    - History of abnormal results in case of an optionally performed pH monitoring of the distal esophagus,
    - Patients with PPI-responsive esophageal eosinophilia
    - Achalasia, scleroderma esophagus, or systemic sclerosis,
    - Other clinically evident causes than EoE for esophageal eosinophilia,
    - Any concomitant esophageal disease and relevant gastro-intestinal disease (celiac disease, inflammatory bowel disease, oropharyngeal or esophageal bacterial, viral, or fungal infection [candida esophagitis]),
    - Any relevant systemic disease (e.g., AIDS, active tuberculosis),
    - If careful medical monitoring is not ensured: cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection,
    - Liver cirrhosis or portal hypertension,
    - History of cancer in the last five years,
    - History of esophageal surgery at any time or of esophageal dilation procedures within the last 8 weeks prior to screening visit,
    - Upper gastrointestinal bleeding within 8 weeks prior to screening visit,
    - Existing or intended pregnancy or breast-feeding.
    -Signos clínicos (es decir, regurgitación ácida y/o acidez de estómago) y signos endoscópicos (al menos Grado A según la clasificación de esofagitis de Los Ángeles) de enfermedad de reflujo gastroesofágico (ERGE).
    -Antecedentes de resultados anómalos en caso de un control opcional del pH de la parte distal del esófago.
    -Pacientes con EES-IBP
    -Acalasia, esclerodermia esofágica o esclerosis sistémica.
    -Otras causas clínicamente evidentes distintas de la EE para la eosinofilia esofágica (es decir, enfermedad de Crohn, gastroenteritis eosinofílica, enfermedad del tejido conjuntivo, vasculitis, síndrome hipereosinofílico, enfermedad de injerto contra huésped, respuesta de hipersensibilidad farmacológica, infestación parasitaria [en los últimos 3 meses previos a la visita de la selección]).
    -Cualquier enfermedad esofágica concomitante y enfermedad gastrointestinal relevante (celiaquía, enfermedad inflamatoria intestinal, infección orofaríngea o esofágica bacteriana, vírica o fúngica [esofagitis por cándida]).
    -Cualquier enfermedad sistémica relevante (p. ej., sida, tuberculosis activa).
    -Si el control médico minucioso no está garantizado: enfermedad cardiovascular, diabetes mellitus, osteoporosis, enfermedad por úlcera péptica activa, glaucoma, cataratas o infección.
    -Cirrosis hepática o hipertensión portal.
    -Antecedentes de cáncer en los últimos 5 años.
    -Antecedentes de cirugía esofágica en cualquier momento o de procedimientos de dilatación esofágica en las 8 semanas previas a la visita de selección.
    -Embarazo existente o intención de quedarse embarazada o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of patients with clinico-pathological remission
    Tasa de pacientes con remisión clinicopatológica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6 (LOCF)
    semana 6 (LOCF)
    E.5.2Secondary end point(s)
    - Rate of patients with histological remission,
    - Change from baseline in histology
    - Rate of patients with resolution of symptoms (i.e., no or only minimal problems of EoE).
    -Tasa de pacientes con remisión histológica
    -Cambio en el valor máximo entre el inicio y la semana 6 (LOCF).
    -Tasa de pacientes con resolución de los síntomas (es decir, ausencia de problemas o problemas mínimos)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6 (LOCF)
    semana 6 (LOCF)
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    6 week open label phase after 6 weeks of treatment for patients not having reached remission
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA45
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    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 years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days14
    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: 80
    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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 90
    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)
    Patients in remission after 6 weeks of treatment in the double-blind phase or in remission after 6 weeks in the open-label phase may enroll the maintenance of remission study BUL-2/EER.
    Otherwise, the treatment after trial end (either after the double-blind phase when a patient is in remission or after follow-up visit as end of the follow-up phase) is left to the investigator?s discretion.
    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 Decision2015-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-04
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