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    The EU Clinical Trials Register currently displays   43887   clinical trials with a EudraCT protocol, of which   7297   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).

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    Summary
    EudraCT Number:2022-003716-91
    Sponsor's Protocol Code Number:CGB-1108
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2022-003716-91
    A.3Full title of the trial
    Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD).
    Randomisierte, kontrollierte klinische Prüfung zur Untersuchung der Wirksamkeit von Alginaten bei Washout einer Protonenpumpeninhibitorentherapie mit Berücksichtigung der Compliance und Symptomlast bei Patienten mit Gastroösophagealer Refluxkrankheit (GERD).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD).
    Randomisierte, kontrollierte klinische Prüfung zur Untersuchung der Wirksamkeit von Alginaten bei Washout einer Protonenpumpeninhibitorentherapie mit Berücksichtigung der Compliance und Symptomlast bei Patienten mit Gastroösophagealer Refluxkrankheit (GERD).
    A.3.2Name or abbreviated title of the trial where available
    CeGaBeGa
    CeGaBeGa
    A.4.1Sponsor's protocol code numberCGB-1108
    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 SponsorCentrum Gastroenterologie Bethanien
    B.1.3.4CountryGermany
    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 supportCentrum Gastroenterologie Bethanien
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMediconomics GmbH
    B.5.2Functional name of contact pointClinical Research Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressMisburger Straße 81B
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number00495115609980
    B.5.5Fax number004951156099820
    B.5.6E-mailinfo@mediconomics.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 Yes
    D.2.1.1.1Trade name Gaviscon Advance Pfefferminz 1000 mg/200 mg Suspension zum Einnehmen im Beutel
    D.2.1.1.2Name of the Marketing Authorisation holderReckitt Benckiser Deutschland 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.3.4Pharmaceutical 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 INNNatriumalginat
    D.3.9.1CAS number 9005-38-3
    D.3.9.3Other descriptive nameSodium alginate
    D.3.9.4EV Substance CodeSUB15270MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKaliumhydrogencarbonat
    D.3.9.1CAS number 298-14-6
    D.3.9.3Other descriptive namePotassium hydrogen carbonate
    D.3.9.4EV Substance CodeSUB12234MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy with consideration of compliance and symptom burden in patients with gastroesophageal reflux disease (GERD).
    Randomisierte, kontrollierte klinische Prüfung zur Untersuchung der Wirksamkeit von Alginaten bei Washout einer Protonenpumpeninhibitorentherapie mit Berücksichtigung der Compliance und Symptomlast bei Patienten mit Gastroösophagealer Refluxkrankheit (GERD).
    E.1.1.1Medical condition in easily understood language
    Randomized controlled clinical trial to evaluate the efficacy of alginates in washout of proton pump inhibitor therapy in patients with gastroesophageal reflux disease.
    Randomisierte, kontrollierte klinische Prüfung zur Untersuchung der Wirksamkeit von Alginaten bei Washout einer Protonenpumpeninhibitorentherapie bei Patienten mit Gastroösophagealer Refluxkrankheit.
    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 LLT
    E.1.2Classification code 10066874
    E.1.2Term Gastroesophageal reflux disease
    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
    • Evaluation of the efficacy of GAVISCON® Advance compared to standard therapy upon PPI discontinuation.
    • Beurteilung der Wirksamkeit von GAVISCON® Advance im Vergleich zur Standardtherapie bei Absetzen von PPI
    E.2.2Secondary objectives of the trial
    • Assessment of tolerability and safety of GAVISCON® Advance compared to standard therapy when discontinuing PPI.
    • Assessment of compliance and symptom burden when using GAVISCON® Advance compared to standard therapy under the specific conditions of discontinuation of PPI therapy.
    • Beurteilung der Verträglichkeit und Sicherheit von GAVISCON® Advance im Vergleich zur Standardtherapie bei Absetzen von PPI
    • Beurteilung der Compliance und Symptomlast bei Einsatz von GAVISCON® Advance im Vergleich zur Standardtherapie unter den spezifischen Bedingungen des Absetzens einer PPI-Therapie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients of either sex aged ≥ 18 years.
    • Outpatients with ongoing PPI therapy (due to GERD) whose ongoing PPI intake is to be discontinued (e.g., prior to a planned diagnostic procedure).
    • Signed consent to participate and to the collection and pseudonymized sharing of personal data.
    • Patienten beiderlei Geschlechts im Alter von ≥ 18 Jahren
    • Ambulante Patienten mit einer laufenden PPI-Therapie (aufgrund einer GERD) deren laufende PPI-Einnahme beendet werden soll (z.B. vor einer geplanten Diagnostik)
    • Unterzeichnete Einwilligung zur Teilnahme und zur Erhebung und pseudonymisierten Weitergabe der persönlichen Daten
    E.4Principal exclusion criteria
    - Uncooperative patients
    - Presence of red flag symptoms (dysphagia, anemia, weight loss in the past 3 months, recurrent bleeding, or recurrent vomiting)
    - Presence of known Barrett's esophagus
    • History of surgery to the esophagus or stomach
    • Hypersensitivity to sodium alginate or potassium bicarbonate
    • Allergy to the sweetener saccharin (E954)
    • Allergy to spices, such as anise, mugwort, dill, fennel, carrot, coriander, cumin, paprika, parsley, celery and tomato
    • Existing alcohol abuse or abuse of medications or drugs.
    • Patients incapable of giving consent
    • Patients who do not have sufficient command of the German language (consent form)
    • Patients who are in a dependent relationship with the sponsor, investigator, other study personnel or the study center
    • Unkooperative Patienten
    • Vorliegen von Red-Flag Symptomen (Dysphagie, Anämie, Gewichtsverlust in den letzten 3 Monaten, wiederkehrende Blutungen oder wiederkehrendes Erbrechen)
    • Vorliegen eines bekannten Barrett-Ösophagus
    • Vorgeschichtliche Operationen an der Speiseröhre oder am Magen
    • Überempfindlichkeit gegenüber Natriumalginat oder Kaliumhydrogencarbonat
    • Allergie gegen das Süßungsmittel Saccharin (E954)
    • Allergie gegen Gewürze, wie z.B. Anis, Beifuß, Dill, Fenchel, Karotte, Koriander, Kümmel, Paprika, Petersilie, Sellerie und Tomaten
    • Bestehender Alkoholabusus bzw. Medikamenten- oder Drogenmissbrauch
    • Einwilligungsunfähige Patienten
    • Patienten, die die deutsche Sprache nicht ausreichend beherrschen (Einverständniserklärung)
    • Patienten, die in einem Abhängigkeitsverhältnis zu Sponsor, Prüfarzt, anderem Studienpersonal oder dem Prüfzentrum stehen
    E.5 End points
    E.5.1Primary end point(s)
    Modification of the sum score on efficacy to 16 items of the GERD-HRQL. The individual items are each rated on a 6-point scale (from 0 = no symptoms to 5 = severely impairing).
    Änderung des Summenscores zur Wirksamkeit auf 16 Items des GERD-HRQL. Die Einzelitems werden jeweils auf einer 6-stufigen Skala bewertet (von 0 = keine Symptome bis 5 = stark beeinträchtigend).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Comparison of the sum score on efficacy to 16 items of the GERD-HRQL. The individual items are each rated on a 6-point scale (from 0 = no symptoms to 5 = severely impairing).
    Vergleich des Summenscores zur Wirksamkeit auf 16 Items des GERD-HRQL. Die Einzelitems werden jeweils auf einer 6-stufigen Skala bewertet (von 0 = keine Symptome bis 5 = stark beeinträchtigend).
    E.5.2Secondary end point(s)
    • Physician's judgment regarding tolerability. Further secondary objective parameters are efficacy and tolerability, which the patient assesses by means of a diary.
    • Change in concomitant medication compared between groups (dose change / medication discontinued / new concomitant medication).
    • Change of concomitant measures/interventions regarding GERD therapy tested (concomitant measure discontinued or new concomitant measure).
    • Urteil des Arztes bzgl. Verträglichkeit. Weitere Nebenzielparameter sind Wirksamkeit und Verträglichkeit, die der Patienten mittels Tagebuches einschätzt.
    • Änderung der Begleitmedikation zwischen den Gruppen verglichen (Dosisänderung / Medikation abgesetzt / neue Begleit-medikation).
    • Änderung der Begleitmaßnahmen/Interventionen bzgl. der GERD-Therapie geprüft (Begleitmaßnahme abgesetzt oder neue Begleitmaßnahme).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Physician's judgment regarding tolerability. Further secondary objective parameters are efficacy and tolerability, which the patient assesses by means of a diary.
    • Change in concomitant medication compared between groups (dose change / medication discontinued / new concomitant medication).
    • Change of concomitant measures/interventions regarding GERD therapy tested (concomitant measure discontinued or new concomitant measure).
    • Urteil des Arztes bzgl. Verträglichkeit. Weitere Nebenzielparameter sind Wirksamkeit und Verträglichkeit, die der Patienten mittels Tagebuches einschätzt.
    • Änderung der Begleitmedikation zwischen den Gruppen verglichen (Dosisänderung / Medikation abgesetzt / neue Begleit-medikation).
    • Änderung der Begleitmaßnahmen/Interventionen bzgl. der GERD-Therapie geprüft (Begleitmaßnahme abgesetzt oder neue Begleitmaßnahme).
    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) 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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    gegen Medical Routine-Treatment (=keine Behandlung)
    against Medical Routine Treatment (=no treatment)
    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
    Final visit of CRA at study site of LVLS
    Abschlussbesuch der CRA am Studienort der 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 2022-12-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    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 state60
    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.
    Keine (Generell besteht für alle Patienten die Möglichkeit, nach Beendigung der Teilnahme an der klinischen Prüfung, soweit erforderlich, individuell entsprechend ihrer Symptomatik nach Maßgabe des sie betreundenden Arztes weiter behandelt zu werden.).
    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 Decision2023-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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