Flag of the European Union EU Clinical Trials Register Help

Clinical trials

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44310   clinical trials with a EudraCT protocol, of which   7356   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-002593-27
    Sponsor's Protocol Code Number:S64291
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-04-12
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-002593-27
    A.3Full title of the trial
    Budesonide as a treatment for low-grade duodenal inflammation in functional dyspepsia.
    Budesonide als behandeling voor laaggradige duodenale inflammatie in functionele dyspepsie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Budesonide as a treatment for inflammation in stomach complaints.
    Budesonide als behandeling voor ontstekingsreacties bij maagklachten.
    A.3.2Name or abbreviated title of the trial where available
    BUDY
    A.4.1Sponsor's protocol code numberS64291
    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 SponsorUZ Leuven
    B.1.3.4CountryBelgium
    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 supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointTARGID
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailtim.vanuytsel@kuleuven.be
    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 Jorveza
    D.2.1.1.2Name of the Marketing Authorisation holderDr. Falk Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 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 number3
    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 placeboCapsule
    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
    Functional dyspepsia
    Functionele dyspepsie
    E.1.1.1Medical condition in easily understood language
    Chronic stomach disease
    Chronische maagklachten
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The effect of Budesonide on duodenal eosinophilia in functional dyspepsia patients.
    Het effect van budesonide op duodenale eosinofilie in functionele dyspepsie patiënten.
    E.2.2Secondary objectives of the trial
    The effect of budesonide in functional dyspepsia on
    - gastric emptying
    - symptom outcome
    - quality of life in patients
    - state of anxiety, depression and somatization
    - mucosal barrier function
    Het effect van budesonide in functionele dyspepsie op:
    - Maaglediging
    - Symptomen
    - Levenskwaliteit
    - Angst, depressie, somatisatie
    - Mucosale permeabiliteit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Functional dyspepsia patients with meal related symptoms (postprandial distress syndrome) as described by the Rome IV criteria
    • Patients aged between 18 and 70 years inclusive
    • Male or female patients
    - Patiënten met functionele dyspepsie met maaltijdgerelateerde klachten, zoals beschreven in de Rome IV criteria.
    - Leeftijd tussen 18 en 70 jaar (70j inclusief)
    - Mannen of vrouwen
    E.4Principal exclusion criteria
    • Patients with any condition which, in the opinion of the investigator, makes the patient unsuitable to participate in the study
    • Patients with any major psychiatric disorders (including those with a major psychosomatic element to their gastrointestinal disease), depression, alcohol or substance abuse in the last 2 years
    • Patients presenting with predominant symptoms of irritable bowel syndrome (IBS) or of gastro-esophageal reflux disease (GERD)
    • Patients with diabetes mellitus, celiac disease, lupus, scleroderma or other systemic auto-immune disease
    • Patients with eosinophilic esophagitis or eosinophilic gastroenteritis
    • Patients with active H. Pylori infection (or < 6 months after eradication)
    • Patients with proven food allergy
    • Patients with an organic gastro-intestinal disease of history of gastrointestinal surgery other than appendectomy
    • Patients with known sever impaired liver dysfunction
    • Patients who take drugs altering gastric emptying, anti-inflammatory drugs, acid suppressive drugs or some drugs altering the CYP3A4 metabolism
    • Patients with major change in diet in the last 3 months
    • Females who are pregnant or lactating
    • Patients not capable to understand or be compliant with the study.
    - Patiënten met een aandoening waardoor ze niet geschikt zijn om deel te nemen aan de studie volgens de mening van de onderzoeker.
    - Patiënten met majeure psychiatrische stoornissen (inclusief secundaire psychosomatische stoornissen in relatie tot hun gastrointestinale ziekte), depressie, alcohol-of drugmisbruik in de laatste 2 jaar
    - Patiënten met predominant klachten van spastisch colon of oesofagale reflux.
    - Patiënten met diabetes mellitus, coeliakie, lupus, scleroderma of andere systemische auto-immuunziekten.
    - Patiënten met eosinofiele oesofagitis of eosinofiele gastroenteritis
    - Patiënten met een actieve H. Pylori infectie ( of minder dan 6 maanden na eradicatie).
    - Patiënten met een bewezen voedselallergie
    - Patiënten met een organische gastrointestinale ziekte of een voorgeschiedenis van gastrointestinale heelkunde (met uitzondering van appendectomie).
    Patiënten met gekend en ernstig leverlijden.
    - Patiënten die medicatie die de maagmotiliteit kan beïnvloeden, anti-inflammatoire medicatie, maagzuurremmers of medicatie die het CYP3A4 metabolisme kan beïnvloeden, nemen.
    - Patiënten met belangrijke dieetwijzigingen de laatste 3 maanden.
    - Vrouwen die zwanger zijn of borstvoeding geven.
    - Patiënten die de studie niet begrijpen of niet compliant zijn.
    E.5 End points
    E.5.1Primary end point(s)
    Duodenal eosinophils
    Duodenale eosinofielen
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before treatment and after 8 weeks of treatment
    Voor behandeling en na 8 weken behandeling
    E.5.2Secondary end point(s)
    - Gastro-intestinal symptoms of patients, based on the Leuven Postprandial Distress Scale (LPDS)
    - Quality of life of patients
    - State of anxiety, depression and somatization
    - Mucosal permeability, including gene and protein expression of major tight-junction related molecules and cytokines
    - Gastric motility by assessing gastric emptying time
    - Gastrointestinale symptomen, gebaseerd op het LPDS dagboek
    - Levenskwaliteit
    - Staat van angst, depressie en somatisatie
    - Mucosale permeabiliteit, inclusief gen-en proteïne expressie van tight junction gerelateerde molecules en cytokines.
    - Maagmotiliteit, via evalueren van maagledigingstijd
    E.5.2.1Timepoint(s) of evaluation of this end point
    Before treatment and after 8 weeks of treatment.
    Gastrointestinal symptoms will be evaluated daily via the LPDS diary.
    Voor behandeling en na 8 weken behandeling.
    Gastrointestinale symptomen zullen dagelijks geëvalueerd worden via het LPDS dagboek.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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 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
    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
    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: 31
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state36
    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
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA