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    Summary
    EudraCT Number:2020-004168-24
    Sponsor's Protocol Code Number:BETHESDaCD
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-01-15
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-004168-24
    A.3Full title of the trial
    Evaluation of the efficacy of topical treatment with budesonide in children
    with Crohn's disease located in the esophagus and/or stomach and/or
    duodenum - BETHESDa
    Ocena skuteczności miejscowego leczenia budezonidem dzieci z chorobą
    Leśniowskiego-Crohna z lokalizacją w przełyku i(lub) żołądku i(lub)
    dwunastnicy - BETHESDa-CD
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the efficacy of topical treatment with budesonide in children
    with Crohn's disease located in the esophagus and/or stomach and/or
    duodenum
    Ocena skuteczności miejscowego leczenia budezonidem dzieci z chorobą
    Leśniowskiego-Crohna z lokalizacją w przełyku i(lub) żołądku i(lub)
    dwunastnicy
    A.4.1Sponsor's protocol code numberBETHESDaCD
    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 SponsorMedical University of Warsaw
    B.1.3.4CountryPoland
    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 supportAgencja Badań Medycznych
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Warsaw Klinika Gastroenterologii i Żywienia Dzieci
    B.5.2Functional name of contact pointclinical trial information desk
    B.5.3 Address:
    B.5.3.1Street AddressŻwirki i Wigury 63a
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-091
    B.5.3.4CountryPoland
    B.5.4Telephone number48223179451
    B.5.6E-mailaleksandra.banaszkiewicz@wum.edu.pl
    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 The IMP is authorized but for a different indication and route of administration. IMP will be budesonide in nebulized suspension but for oral administration. The idea is local action, low dose available in this formula and very low bioavailability.
    D.2.1.1.2Name of the Marketing Authorisation holderADAMED SP. Z O.O.
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameBudezonide
    D.3.4Pharmaceutical form Suspension for oral suspension
    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/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 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 Omeprazol
    D.2.1.1.2Name of the Marketing Authorisation holderKRKA
    D.2.1.2Country which granted the Marketing AuthorisationSlovenia
    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 nameOmeprazol
    D.3.4Pharmaceutical form Capsule
    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 INNOmeprazole
    D.3.9.1CAS number 73590-58-6
    D.3.9.4EV Substance CodeSUB09439MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    Crohn's disease
    Choroba Leśniowskiego- Crohna
    E.1.1.1Medical condition in easily understood language
    gastroenterology
    gastroenterologia
    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 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    THE OBJECTIVE OF THE STUDY IS TO ASSESS THE EFFECTIVENESS OF
    TOPICALLY APPLIED BUDESONIDE IN THE TREATMENT OF
    INFLAMMATIVE LEASES IN THE OESPHAGOM AND/OR THE GASTRIC
    AND/OR THE DUDENUM IN CHILDREN WITH LEŚNIOWSKI-CROHN'S
    DISEASE
    CELEM BADANIA JEST OCENA SKUTECZNOŚCI MIEJSCOWO
    STOSOWANEGO BUDEZONIDU W LECZENIU ZMIAN ZAPALNYCH W
    PRZEŁYKU I/LUB ŻOŁĄDKU I/LUB DWUNASTNICY U DZIECI Z CHOROBĄ
    LEŚNIOWSKIEGO- CROHNA
    E.2.2Secondary objectives of the trial
    not applicable
    nie dotyczy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -age 6-18;
    -CD diagnosed according to commonly accepted criteria from Porto,
    taking into account clinical, endoscopic and histopathological criteria;
    inflammatory changes in the esophagus and/or stomach and/or
    duodenum found in an endoscopic examination (assessed by 2
    - independent endoscopists) and confirmed in a histopathological
    examination (on the Paris scale CD-C activity: L4a, i.e. involvement of
    the upper gastrointestinal tract to the Treitz ligament); - if a previous examination is used - the histopathological result cannot be older than 31 days before randomization;
    -stable, understood as no treatment modification, CD treatment for ≥2 weeks;
    exclusion of causes of inflammatory changes in the esophagus and/or
    stomach and/or duodenum other than CD, such as: reflux esophagitis,
    esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic
    esophagitis and/or gastroduodenitis, Helicobacter pylori infection;
    -informed consent of the child's parents or guardians to participate in
    the study; for children ≥ 16 years of age additionally, the consent of the
    child participating in the study
    declaration of sexual abstinence during the entire participation in the study
    -wiek 6-18 lat;
    ­ -ChL-C rozpoznana wg powszechnie przyjętych kryteriów z Porto
    uwzględniających kryteria kliniczne, endoskopowe i histopatologiczne;
    ­ -zmiany zapalne w przełyku i/lub żołądku i/lub dwunastnicy
    stwierdzone w badaniu endoskopowym (oceniane przez 2 niezależnych
    endoskopistów) i potwierdzone w badaniu histopatologicznym (w skali
    Paryskiej aktywność ChL-C: L4a, czyli zajęcie górnego odcinka przewodu
    pokarmowego do więzadła Treitza); - w przypadku wykorzystania wcześniejszego badania - wynik histopatologiczny nie może być starszy niż 31 dni przed randomizacją;
    ­ -stabilne, rozumiane jako brak modyfikacji leczenia, leczenie ChL-C
    przez ≥2 tyg;
    ­ -wykluczenie innych, poza ChL-C, przyczyn zmian zapalnych w
    przełyku i/lub żołądku i/lub dwunastnicy takich jak: refluksowe
    zapalenie przełyku, opryszczkowe zapalenie przełyku,
    cytomegalowirusowe zapalenie przełyku, eozynofilowe zapalenie przełyku i(lub) żołądka i(lub) dwunastnicy, zakażenie Helicobacter pylori;
    ­ -świadoma zgoda rodziców lub opiekunów dziecka na udział w
    badaniu; w przypadku dzieci ≥ 16 r.ż. dodatkowo zgoda dziecka
    biorącego udział w badaniu
    ­deklaracja wstrzemięźliwości seksualnej podczas całego udziału w badaniu
    E.4Principal exclusion criteria
    age <6 years or >18 years of age;
    other causes of inflammatory changes in the esophagus and/or stomach
    and/or duodenum, other than CD, such as reflux esophagitis,
    esophagitis herpetiformis, cytomegalovirus esophagitis, eosinophilic
    esophagitis and/or gastroduodenitis, infection Helicobacter pylori;
    use of general steroids up to 30 days prior to study entry;
    use of inhaled steroids up to 30 days prior to study entry;
    PPI use up to 30 days prior to study entry;
    acute viral or bacterial infection up to 30 days prior to study entry;
    morning cortisol <5 ug/dL;
    lack of informed consent of the child's parents or guardians to
    participate in the study; for children ≥16 years of age lack of consent of
    the child to participate in the study.
    patient's pregnancy;
    breastfeeding;
    lack of consent of a woman of reproductive age or a fertile man to follow contraceptive recommendations during the examination;
    the patient has had cancer
    ­ wiek <6 r.ż. lub >18 r.ż.;
    ­ inne, poza ChL-C, przyczyny zmian zapalnych w przełyku i/lub żołądku
    i/lub dwunastnicy takie jak: refluksowe zapalenie przełyku,
    opryszczkowe zapalenie przełyku, cytomegalowirusowe zapalenie
    przełyku, eozynofilowe zapalenie przełyku i(lub) żołądka i(lub)
    dwunastnicy, zakażenie Helicobacter pylori;
    ­ stosowanie steroidów ogólnie do 30 dni przed włączeniem do badania;
    ­ stosowanie steroidów wziewnie do 30 dni przed włączeniem do
    badania;
    ­ stosowanie IPP do 30 dni przed włączeniem do badania;
    ­ ostre zakażenie wirusowe lub bakteryjne do 30 dni przed włączeniem
    do badania;
    ­ poranny kortyzol <5 ug/dl;
    ­ brak świadomej zgody rodziców lub opiekunów dziecka na udział w
    badaniu; w przypadku dzieci ≥16 r.ż. brak zgody dziecka na udział w badaniu
    ciąża pacjentki;
    karmienie piersią;
    brak zgody kobiety w wieku rozrodczym lub płodnego mężczyzny na stosowanie się w czasie badania do zaleceń antykoncepcyjnych;
    pacjent chorował na nowotwór
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with no endoscopic and histopathological
    changes in the esophagus and/or stomach and/or duodenum
    Odsetek pacjentów, u których nie stwierdza się zmian endoskopowych i
    histopatologicznych w przełyku i/lub żołądku i/lub dwunastnicy
    E.5.1.1Timepoint(s) of evaluation of this end point
    in the 8th week of the study
    w 8 tygodniu badania
    E.5.2Secondary end point(s)
    - the proportion of patients with no evidence of endoscopic changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the tests) - 8th week;
    - percentage of patients with no histopathological changes in the esophagus, stomach, duodenum, respectively (which were present at entry into the study) - 8th week;
    - disease activity assessed on the PCDAI scale (Pediatric Crohn Disease Activity Index) assessed in the 8th week;
    - the percentage of patients whose upper gastrointestinal symptoms disappeared - 4th, 8th, 12th week;
    - a percentage of patients with adverse effects of steroids - 4th, 8th, 12th week;
    - assessment of treatment tolerance on a 10-point VAS scale - 4th, 8th week.
    - odsetek pacjentów, u których nie stwierdza się zmian endoskopowych odpowiednio w przełyku, żołądku, dwunastnicy (które były obecne w chwili włączenia do
    badania) - w 8 tygodniu trwania badania,
    - odsetek pacjentów, u których nie stwierdza się zmian histopatologicznych odpowiednio w przełyku, żołądku, dwunastnicy (które były obecne w chwili włączenia do
    badania). - w 8 tygodniu trwania badania
    - aktywność choroby oceniana w skali PCDAI (Pediatric Crohn Disease Activity Index) - w 8 tygodniu trwania badania;
    - odsetek pacjentów, u których ustąpiły objawy z górnego odcinka przewodu pokarmowego - oceniany w 4, 8 i 12 tygodniu trwania badania;
    - odsetek pacjentów, u których stwierdzono działania niepożądane steroidów - oceniany w 4, 8 i 12 tygodniu trwania badania;
    - ocena tolerancji leczenia w 10-stopniowej skali VAS - oceniany w 4, 8 tygodniu trwania badania.
    E.5.2.1Timepoint(s) of evaluation of this end point
    in the 4th, 8th and 12th week of the study
    w 4, 8 i 12 tygodniu badania
    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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) 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 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 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
    ostatnia wizyta/ ostatni pacjent
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 138
    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: 69
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 69
    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 2021-01-15. 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 state138
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 138
    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
    nie odbiega
    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 Decision2023-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-14
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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