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    Summary
    EudraCT Number:2016-003739-40
    Sponsor's Protocol Code Number:59153
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-03-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003739-40
    A.3Full title of the trial
    The effect of Iberogast on heartburn in patients with dyspepsia
    Het effect van Iberogast op pyrosisklachten bij patiënten met dyspepsie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Iberogast on heartburn in patients with indigestion.
    Het effect van Iberogast bij patiënten met zuurbranden en maagklachten
    A.3.2Name or abbreviated title of the trial where available
    Iberogast and heartburn
    Iberogast en pyrosis
    A.4.1Sponsor's protocol code number59153
    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 SponsorAMC Amsterdam
    B.1.3.4CountryNetherlands
    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 supportAMC Amsterdam
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportBayer Vital GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMC Amsterdam
    B.5.2Functional name of contact pointmotiliteitscentrum
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205666961
    D. IMP Identification
    D.IMP: 1
    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 Iberogast
    D.2.1.1.2Name of the Marketing Authorisation holderBayer B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.4Pharmaceutical form Oral liquid
    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 No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 liquid
    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
    Dyspepsia (according to the Rome III criteria) with heartburn.
    Upper gastro-intestinal causes of the complaints excluded via gastroscopy
    Dyspepsie (volgens de Rome III criteria) met bijkomend zuurbranden.
    Gastroscopie reeds gebeurd voor bovenste gastro-intestinale oorzaken uit te sluiten.
    E.1.1.1Medical condition in easily understood language
    Complaints of heartburn and indigestion. No abnormalities during endoscopy.
    Klachten van zuurbranden en maagklachten. Geen afwijkingen bij endoscopie.
    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
    To assess the effect of Iberogast on heartburn, the number of reflux episodes and sensitivity in patients with dyspepsia.
    Het effect nagaan van Iberogast op zuurbranden, het aantal reflux episodes, en de sensitiviteit in patiënten met dyspepsie.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age above 18
    • A history of dyspepsia (according to the Rome III criteria) with heartburn
    • Upper gastro-intestinal causes of the complaints excluded via gastroscopy with in addition an abdominal echography if found to be necessary by the physician
    - Ouderdom boven 18
    - Klachten van dyspepsie (volgens de Rome III criteria) en zuurbranden
    - Er is een gastroscopie gebeurd om sommige oorzaken van de klachten uit te sluiten met bijkomend een abdominale echografie indien de arts dit nodig acht.
    E.4Principal exclusion criteria
    • Surgery of the GI tract other than appendectomy or cholecystectomy
    • Use of any medication with a potential effect on gastrointestinal motility, secretion or sensitivity that cannot be stopped for the duration of the study (e.g. proton pump inhibitors, H2-blockers, tricyclic antidepressants …)
    • Proton pump inhibitors cannot be stopped for 7 days before start of the study
    • Known Barrett’s oesophagus
    • History of GI cancer
    • Known allergy to one of the ingredients of Iberogast
    • Known diabetes
    • Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
    • Pregnancy (women will be asked if they are pregnant)
    - Chirurgie van het gastrointestinaal stelsel behalve appendectomie of cholecystectomie
    - Gebruik van medicatie met een potentieel effect op de gastro-intestinale motiliteit, secretie en/of gevoeligheid die niet kan worden gestopt voor de duur van de studie (bijv. proton pomp inhibitoren, H2-antagonisten, tricyclische antidepressiva...)
    - Proton pomp inhibitoren die niet gestopt kunnen worden voor 7 dagen voorafgaand aan het onderzoek
    - Gekende Barrett slokdarm
    - Voorgeschiedenis van gastro-intestinale kanker
    - Gekende allergieën voor één van de ingrediënten van Iberogast
    - Gekende diabetes
    - Ernstige en klinisch onstabiele, gelijktijdig optredende ziekte (bijv. lever-, hart- of longziekte, neurologische of psychiatrische aandoeningen, kanker of AIDS of andere endocriene aandoeningen)
    - Zwangerschap (vrouwen zullen worden gevraagd of ze zwanger zijn)
    E.5 End points
    E.5.1Primary end point(s)
    Gastro-oesophageal reflux disease symptom score improvement based on RDQ Questionnaire score
    GERD symptoom score verbetering gebaseerd op de RDQ questionnaire score
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 4 and week 8
    Week 4 en week 8
    E.5.2Secondary end point(s)
    Number of gastro-oesophageal reflux episodes during the 24-hr study (both mixed/liquid reflux episodes and both acidic and non-acidic episodes)
    Proportion of acid and non-acid reflux episodes
    Total acid exposure time during 24-hour pH-impedance studies
    Quality of life (using the Quality of life in Reflux and Dyspepsia QoLRaD Questionnaire)
    Oesophageal sensitivity to acid perfusion
    Time to symptoms during oesophageal acid exposure
    Time to pain during oesophageal acid exposure (if present)
    Symptom severity during oesophageal acid exposure (VAS)
    Aantal reflux episodes gedurende de 24 uur meting (beide mixed/vloeibare reflux episodes en ook zure en niet-zure episodes)
    Proportie van zuur en niet-zure reflux episodes
    Totale zuurexpositie gedurende de 24-uur pH-impedantie studie
    Kwaliteit van leven (gebaseerd op de QoLRaD questionnaire)
    Slokdarmgevoeligheid voor zuur perfusie
    Tijd tot symptomen gedurende zuurperfusie
    Tijd tot pijn gedurende zuurperfusie (indien aanwezig)
    Symptoom sterkte tijdens zuurperfusie (VAS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 4 and week 8
    Week 4 en week 8
    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 No
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 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 years1
    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: 18
    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 state18
    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
    Geen
    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 Decision2017-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-07-07
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