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    Summary
    EudraCT Number:2013-001256-36
    Sponsor's Protocol Code Number:FACH/023212
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-03
    Trial results View 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 number2013-001256-36
    A.3Full title of the trial
    Pilot study with Staatl. Fachingen STILL for functional dyspepsia (particularly heartburn)
    Pilotstudie mit Staatl. Fachingen STILL bei funktionellen dyspeptischen Beschwerden (insbesondere Sodbrennen)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot study with Staatl. Fachingen STILL for indigestion complaints (particularly heartburn)
    Pilotstudie mit Staatl. Fachingen STILL bei dyspeptischen Beschwerden (insbesondere Sodbrennen)
    A.4.1Sponsor's protocol code numberFACH/023212
    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 SponsorFachingen Heil- und Mineralbrunnen GmbH
    B.1.3.4CountryGermany
    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 supportFachingen Heil- und Mineralbrunnen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFachingen Heil- und Mineralbrunnen GmbH
    B.5.2Functional name of contact pointMarketing Staatl. Fachingen
    B.5.3 Address:
    B.5.3.1Street AddressBrunnenstrasse 11
    B.5.3.2Town/ cityBirlenbach OT Fachingen/Lahn
    B.5.3.3Post code65626
    B.5.3.4CountryGermany
    B.5.4Telephone number00496432983468
    B.5.5Fax number00496432983499
    B.5.6E-mailheiner.wolters@fachingen.de
    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 Staatl. Fachingen STILL
    D.2.1.1.2Name of the Marketing Authorisation holderFachingen Heil- und Mineralbrunnen 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 Oral liquid
    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 INNHeilwasser
    D.3.9.3Other descriptive nameThe active principle of the IMP is the fixed combination of inorganic salts and free carbon dioxide.
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.3Concentration number100
    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) 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 Yes
    D.3.11.13.1Other medicinal product typeStaatl. Fachingen STILL is a healing water with main components Na, HCO3 and CO2.
    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
    Functional dyspeptic complaints, particularly heartburn (at least 3 months prior to study start, at least twice per week)
    Funktionelle dyspeptischen Beschwerden, insbesondere Sodbrennen (seit mindestens 3 Monaten vor Studienbeginn, mindestens zweimal pro Woche)
    E.1.1.1Medical condition in easily understood language
    Heartburn (at least 3 months prior to study start, at least 2x/week)
    Sodbrennen (seit mindestens 3 Monaten vor Studienbeginn, mindestens 2x pro Woche)
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10019326
    E.1.2Term Heartburn
    E.1.2System Organ Class 100000004856
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Investigation of the efficacy and tolerability of Staatl. Fachingen STILL in the pre / post comparison.

    Efficacy parameters:
    -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI))
    -Difference in the frequency of heartburn episodes per week
    -Difference in the subjective perception of well-being (SF-12 questionnaire )
    -Differences in laboratory parameters (liver function, lipid metabolism)
    -Difference in body weight
    -Global assessment of efficacy by patient and investigator

    Tolerability parameters:
    -Adverse events (AEs)
    -Difference in blood pressure
    -Global assessment of tolerability by patient and investigator
    Untersuchung der Wirkung und der Vertraeglichkeit von Staatl. Fachingen STILL im prae/post Vergleich.

    Zielkriterien zur Bewertung der Wirkung sind:
    -Therapeutischer Verlauf anhand von Fragebogen-Werten ("Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI))
    -Unterschied in der Haeufigkeit von Sodbrennen-Episoden pro Woche
    -Unterschied in der subjektiven Wahrnehmung der Befindlichkeit (SF-12 Fragebogen)
    -Unterschiede in Laborparametern (Leberfunktion, Fettstoffwechsel)
    -Unterschied im Koerpergewicht
    -Globale Beurteilung der Wirksamkeit durch Patienten und Pruefer

    Zielkriterien zur Bewertung der Vertraeglichkeit sind:
    -Analyse von unerwuenschten Wirkungen
    -Unterschied im Blutdruck
    -Globale Beurteilung der Vertraeglichkeit durch Patienten und Pruefer
    E.2.2Secondary objectives of the trial
    As the study is designed as pilot study, there are no primary and secondary objectives defined.
    Im Sinne einer Pilotstudie sind keine primaeren und sekundaeren Zielkriterien definiert.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria:
    -Age between 18 and 65 years
    -Heartburn in at least 3 months prior to the study, at least 2 times a week (according to patient's statement)
    -Not receiving prescribed treatment for heartburn, reflux or upper gastrointestinal disorders
    -Subject is used to consuming at least 1.5 l of water (incl. tea) or mineral water daily (according to patient's statement)
    -Commitment to adhere to former diet
    -Commitment to only use the investigational product personally
    -Women of childbearing potential: commitment to use contraception methods
    Written informed consent is a prerequisite for patient enrollment.

    Criteria for study continuation (at Visit 2):
    -Heartburn at least 2 times a week (according to subject's diary between Visit 1 and Visit 2)
    -Intake of at least 1500 ± 200 ml water (incl. tea) daily (according to patient's diary between Visit 1 and Visit 2
    Einschlusskriterien:
    -Alter: 18 - 65 Jahre
    -Sodbrennen seit mindestens 3 Monaten vor Studienbeginn, mindestens 2x pro Woche (nach muendlichen Angaben des Patienten)
    -Keine verordnete Behandlung des Sodbrennens, des gastro-oesophagealen Refluxes oder der Erkrankungen des oberen Magen-Darm-Trakts
    -Patient ist gewohnt, taeglich mind. 1,5 l Wasser (inkl. Tee) oder Mineralwasser zu trinken (nach muendlichen Angaben des Patienten)
    -Patient ist bereit, seine Ernaehrungsgewohnheiten waehrend der Studie nicht zu aendern
    -Patient stellt sicher, dass das Pruefpraeparat ausschliesslich zum eigenen Verzehr eingenommen wird
    -Konzeptionsschutz vorhanden (bei gebaerfaehigen Frauen)
    Eine schriftliche Einwilligung des Patienten nach schriftlicher und muendlicher Aufklaerung durch den Pruefer ueber Wesen, Tragweite, Bedeutung und moegliche Risiken der klinischen Pruefung ist die Voraussetzung für die Teilnahme an der klinischen Pruefung.

    Kriterien fuer weitere Teilnahme (zur Visite 2):
    -Sodbrennen mindestens 2x pro Woche (nach Angaben im Patiententagebuch zwischen Visite 1 und Visite 2)
    -Verzehr von mind. 1500 ± 200 ml Wasser (inkl. Tee) pro Tag (nach Angaben im Patiententagebuch zwischen Visite 1 und Visite 2)
    E.4Principal exclusion criteria
    -Weight loss of ≥ 6 kg in the last 6 months prior to the study
    -Gastrointestinal bleeding within 12 months prior to the study
    -Difficulty swallowing (dysphagia)
    -Zollinger–Ellison syndrome, oesophageal or gastric malignancy, gastric or duodenal ulcer, pernicious anaemia, Barrett’s oesophagus or systemic sclerosis
    -Coronary disease (e.g. myocardial infarction, coronary stent, angina pectoris symptoms etc.)
    -Anorexia
    -Inflammatory bowel syndrome
    -Previous surgery of the oesophagus, stomach or small intestine
    -Acute or chronic intestinal diseases (e.g. constipation, colonic stenosis etc. )
    -Endocrine disorders (e.g. diabetes mellitus, thyroid dysfunction)
    -Severe renal impairment
    -Iron deficiency anemia
    -Persistent vomiting
    -Family history of gastrointestinal tract malignancy
    -Clinically relevant deviations of laboratory parameters
    -Use of antacids, H2 receptor antagonists, motility stimulants, prokinetics or other treatment for the relief of reflux within 2 days or proton-pump inhibitors or psychiatric medication within 14 days prior to study start and during the study
    -Use of treatment for Helicobacter pylori eradication or bismuth compounds within 3 months prior to study start and during the study
    -Use of acetylsalicylic acid and nonsteroidal anti-inflammatory drugs during the study
    -Intake of mineral water other than the investigational product during the study
    -Pregnancy or nursing (women of childbearing potential)
    -Drug, alcohol or medication abuse
    -Participation in another clinical trial during the last 30 days prior to study start and during the study
    -Persons that are in relationship or dependence to the sponsor or the investigator
    -Evidence that the subject would not be able to comply with clinical trial requirements (e.g. limited willingness to cooperate)
    -Gewichtsverlust von ≥ 6 kg in den letzten 6 Monaten vor der Studie
    -Magen-Darm-Blutungen innerhalb der letzten 12 Monaten vor der Studie
    -Schluckbeschwerden (Dysphagie)
    -Zollinger-Ellison-Syndrom, maligne Erkrankung der Speiseroehre oder des Magens, Magen oder Zwoelffingerdarmgeschwuer, Barrett-Oesophagus, Oesophagusvarizen oder systemische Sklerose
    -Herzerkrankungen (z.B. Herzinfarkt, koronarer Stent, pektanginoese Beschwerden etc.)
    -Anorexia
    -Reizdarmsyndrom
    -Chirurgische Eingriffe im Bereich des Oesophagus und des Magen-Duenndarmbereiches (anamnestische Angaben)
    -Akute oder chronische Darmerkrankungen (z.B. Obstipation, Darmstenose etc.)
    -Endokrine Erkrankungen (z.B. Diabetes mellitus, Schilddruesenfunktionsstoerung)
    -Schwere Niereninsuffizienz
    -Eisenmangelanaemie
    -Persistierendes Erbrechen
    -Familiaere Tumorbelastung im gastrointestinalen Trakt
    -Klinisch relevante Laborwertabweichung
    -Anwendung von Antazida, H2-Rezeptorantagonisten, Motilitaet stimulierenden Praeparaten/Prokinetika sowie weiteren Praeparaten zur Behandlung von gastro- oesophagealen Reflux innerhalb der letzten 2 Tage vor Studienbeginn; Anwendung von Protonenpumpenhemmer oder Psychopharmaka innerhalb der letzten 14 Tage vor Studienbeginn und während der Studie
    -Anwendung von Praeparaten zur Helicobacter pylori- Therapie, Wismut-Praeparaten innerhalb der letzten 3 Monate vor Studienbeginn und waehrend der Studie
    -Anwendung von Acetylsalicylsaeure und nichtsteroidaler Antirheumatika waehrend der Studie
    -Einnahme von anderen Heilwaessern / Mineralwaessern waehrend der Studie
    -Schwangerschaft/Stillzeit (bei gebaerfaehigen Frauen)
    -Medikamenten-, Alkohol- und/oder Drogenabusus
    -Gleichzeitige Teilnahme an einer anderen klinischen Pruefung oder Teilnahme an einer solchen innerhalb der letzten 30 Tage
    -Abhaengigkeits- / Arbeitsverhaeltnis zum Sponsor oder Pruefer
    -Anzeichen dafuer, dass der Patient den Pruefplan voraussichtlich nicht einhalten wird (z.B. mangelnde Kooperationsbereitschaft)
    E.5 End points
    E.5.1Primary end point(s)
    Investigation of the efficacy and tolerability of Staatl. Fachingen STILL in the pre / post comparison.

    Efficacy parameters:
    -Therapeutic course based on the questionnaire data (questionnaires "Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI))
    -Difference in the frequency of heartburn episodes per week
    -Difference in the subjective perception of well-being (SF-12 questionnaire )
    -Differences in laboratory parameters (liver function, lipid metabolism)
    -Difference in body weight
    -Global assessment of efficacy by patient and investigator

    Tolerability parameters:
    -Adverse events (AEs)
    -Safety laboratory parameters
    -Difference in blood pressure
    -Global assessment of tolerability by patient and investigator
    Untersuchung der Wirkung und der Vertraeglichkeit von Staatl. Fachingen STILL im prae/post Vergleich.

    Zielkriterien zur Bewertung der Wirkung sind:
    -Therapeutischer Verlauf anhand von Fragebogen-Werten ("Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI))
    -Unterschied in der Haeufigkeit von Sodbrennen-Episoden pro Woche
    -Unterschied in der subjektiven Wahrnehmung der Befindlichkeit (SF-12 Fragebogen)
    -Unterschiede in Laborparametern (Leberfunktion, Fettstoffwechsel)
    -Unterschied im Koerpergewicht
    -Globale Beurteilung der Wirksamkeit durch Patienten und Pruefer

    Zielkriterien zur Bewertung der Vertraeglichkeit sind:
    -Analyse von unerwuenschten Wirkungen
    -Sicherheitsblutparameter
    -Unterschied im Blutdruck
    -Globale Beurteilung der Vertraeglichkeit durch Patienten und Pruefer
    E.5.1.1Timepoint(s) of evaluation of this end point
    Efficacy:
    -Therapeutic course based on the questionnaire data (RDQ/QOLRAD/GLQI) at V2, V3 and V4
    -Frequency of heartburn episodes per week in the week before V2, V3 and V4 each
    -Subjective perception of well-being (SF-12) at V2, V3 and V4
    -Laboratory parameters (liver function, lipid metabolism) at V1 and V4
    -Body weight at V1 and V4
    -Global assessment of efficacy by patient and investigator at V4

    Tolerability:
    -AEs during the study
    -Safety laboratory parameters at V1 and V4
    -Blood pressure at V2, V3 and V4
    -Global assessment of tolerability by patient and investigator at V4
    Wirkung:
    -Therapeutischer Verlauf anhand von Fragebogen-Werten ("Reflux Disease Questionnaire" (RDQ) / "Quality of Life in Reflux and Dyspepsia" (QOLRAD) / "Gastrointestinal Quality of Life Index" (GLQI)) zu V2, V3 und V4
    -Haeufigkeit von Sodbrennen-Episoden pro Woche in der jeweiligen Woche vor V2, V3 und V4
    -Subjektive Wahrnehmung der Befindlichkeit (SF-12 Fragebogen) zu V2, V3 und V4
    -Laborparameter (Leberfunktion, Fettstoffwechsel) zu V1 und V4
    -Koerpergewicht zu V1 und V4
    -Globale Beurteilung der Wirksamkeit durch Patienten und Pruefer zu V4

    Vertraeglichkeit:
    -Analyse von unerwuenschten Wirkungen
    -Sicherheitsblutparameter zu V1 und V4
    -Unterschied im Blutdruck
    -Globale Beurteilung der Vertraeglichkeit durch Patienten und Pruefer
    E.5.2Secondary end point(s)
    As the study is designed as pilot study, there are no primary and secondary objectives defined.
    Im Sinne einer Pilotstudie sind keine primaeren und sekundaeren Zielkriterien definiert.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As the study is designed as pilot study, there are no primary and secondary objectives defined.
    Im Sinne einer Pilotstudie sind keine primaeren und sekundaeren Zielkriterien definiert.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pilotstudie
    Pilot study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    database closure
    Datenbankschluss
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months8
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state56
    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)
    After the subject has ended the participation the treatment is not different from the expected normal treatment.
    Nach der Teilnahme an der Studie, wird sich die Behandlung nicht von der herkömmlichen Behandlung unterscheiden.
    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 Decision2013-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-07-14
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