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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43693   clinical trials with a EudraCT protocol, of which   7245   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 on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2017-003737-29
    Sponsor's Protocol Code Number:BUU-5/EEA
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-01-18
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2017-003737-29
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis
    Ensayo doble ciego, aleatorizado, controlado con placebo y de fase II/III sobre la eficacia y la tolerabilidad de un tratamiento con suspensión oral de budesónida en comparación con placebo en niños y adolescentes con esofagitis eosinofílica
    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 be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis
    Doble ciego (ni médico ni paciente conocen el tratamiento real el cuál puede ser con o sin sustancia activa), aleatorizado (el paciente será asignado a un cierto grupo de tratamiento al azar), controlado con placebo (uno de los grupos de tratamiento recibe medicación sin sustancia activa), estudio de fase II/III sobre la eficacia y tolerabilidad de la suspensión oral de budesónida en comparación con placebo en niños y adolescentes con esofagitis eosinofílica
    A.3.2Name or abbreviated title of the trial where available
    Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis
    Suspensión oral de budesónida vs. placebo en esofagitis eosinofílica pediátrica
    A.4.1Sponsor's protocol code numberBUU-5/EEA
    A.5.4Other Identifiers
    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.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.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.5.4Telephone number+34913756930
    B.5.5Fax number+34917542721
    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 nameBudesonide oral suspension [0.2 mg/ml]
    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 typeequal
    D.3.10.3Concentration number0.2
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboOral suspension
    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 and maintenance of remission in eosinophilic esophagitis
    Esofagitis eosinofílica activa y mantenimiento en la remisión de la esofagitis eosinofílica
    E.1.1.1Medical condition in easily understood language
    Allergic inflammatory disease of the gullet in its active and in its chronic symptom-free phase
    Enfermedad inflamatoria alérgica del esófago en su fase activa y en su fase crónica sin síntomas
    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 20.1
    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
    Double-blind phase:
    To prove superior efficacy of budesonide oral suspension compared to placebo in children and adolescents with eosinophilic esophagitis (EoE)
    Fase doble ciego:
    Demostrar la eficacia superior de la suspensión oral de budesónida respecto a placebo en niños y adolescentes con esofagitis eosinofílica (EE)
    E.2.2Secondary objectives of the trial
    Double-blind phase:
    To further assess efficacy of budesonide oral suspension in children and adolescents with eosinophilic esophagitis (EoE)
    Fase doble ciego:
    Seguir evaluando la eficacia de la suspensión oral de budesónida en niños y adolescentes con esofagitis eosinofílica (EE)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria for DB-treatment phase:
    - Signed informed consent
    - Male or female patients, ≥2 to <18 years of age
    - Confirmed clinico-pathological diagnosis of EoE according to established diagnostic criteria
    - Clinically and histologically active EoE
    - Negative pregnancy test in female patients of childbearing potential
    Criterios de inclusión para la fase de doble ciego:
    - Consentimiento informado firmado
    - Pacientes de ambos sexos, de ≥2 a <18 años de edad
    - Diagnóstico clinicopatológico confirmado de EE según los criterios diagnósticos establecidos
    - EE clínicamente e histologicamente activa
    - Test de embarazo negativo en pacientes mujeres en edad fértil
    E.4Principal exclusion criteria
    Exclusion criteria for DB treatment phase:
    - Erosive gastroesophageal reflux disease (GERD)
    - 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 untreated or inadequately treated fungal infection [candida esophagitis])
    - Any known relevant infectious diseases (e.g., AIDS defining disease, active tuberculosis, hepatitis B, or hepatitis C)
    - Diabetes mellitus
    - If careful medical monitoring is not ensured: cardiovascular disease, hypertension, osteoporosis, active peptic ulcer disease, glaucoma, cataract, or infection
    - History of cancer in the last five years
    - History of esophageal surgery at any time or of esophageal dilation procedures within the last 4 weeks prior to screening endoscopy, or need for an immediate endoscopic intervention due to a stricture
    - Upper gastrointestinal bleeding within 8 weeks prior to screening endoscopy
    - Existing or intended pregnancy or breast-feeding
    Criterios de exclusión para la fase de tratamiento doble ciego:
    - Enfermedad de reflujo gastroesofágico erosivo (ERGE)
    - Acalasia, esclerodermia esofágica o esclerosis sistémica
    - Otras causas clínicamente evidentes distintas de la EE para la eosinofilia esofágica
    - Cualquier enfermedad esofágica concomitante y enfermedad gastrointestinal relevante (celiaquía, enfermedad inflamatoria intestinal, infección orofaríngea o esofágica bacteriana, vírica o fúngica [esofagitis por cándida] no tratada o tratada de forma insuficiente)
    - Cualquier enfermedad infecciosa relevante conocida (p. ej., enfermedad definitoria de sida, tuberculosis activa, hepatitis B o hepatitis C)
    - Diabetes mellitus
    - Si el control médico minucioso no está garantizado: enfermedad cardiovascular, hipertensión, osteoporosis, enfermedad por úlcera péptica activa, glaucoma, cataratas o infección
    - Antecedentes de cáncer en los 5 años anteriores
    - Antecedentes de cirugía esofágica en cualquier momento o de procedimientos de dilatación esofágica en las 4 semanas previas a la endoscopia de la selección, o necesidad de intervención endoscópica inmediata debido a una estenosis
    - Hemorragia gastrointestinal superior en las 8 semanas previas a la endoscopia de selección
    - Embarazo existente o intención de quedarse embarazada o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Double-blind phase:
    Rate of patients with pathological remission and clinical response at DB week 12
    Fase doble ciego:
    Tasa de pacientes con remisión patológica y respuesta clínica en la semana 12 de DC
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    Semana 12
    E.5.2Secondary end point(s)
    Double-blind phase:
    - Rate of patients with histological remission at DB week 12
    - Rate of patients with clinical response at DB week 12
    Fase doble ciego:
    - Tasa de pacientes con remisión histológica en la semana 12 de DC
    - Tasa de pacientes con respuesta clínica en la semana 12 de DC
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12
    Semana 12
    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 Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    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. trial design description
    más 2 verum fases abiertas opcionales:12 semanas para inducción y 24 semanas mantenimiento remisión
    plus 2 optional open-label verum-phases: 12 wk for induction and 24 wk for maintenance of 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 trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    United Kingdom
    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
    Ultima visita último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial 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: 75
    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. of subjects for this age range: 37
    F.1.1.6Adolescents (12-17 years) Yes
    F. of subjects for this age range: 38
    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 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 66
    F.4.2.2In the whole clinical trial 75
    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)
    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 Decision2019-04-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-29
    P. End of Trial
    P.End of Trial StatusOngoing
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