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    Summary
    EudraCT Number:2013-000861-36
    Sponsor's Protocol Code Number:ENS/007612
    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:2013-04-18
    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 number2013-000861-36
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of „Ensinger Schiller Quelle Heilwasser“ on improvement of bowel function
    Doppelblinde, randomisierte, placebokontrollierte klinische Prüfung zur Untersuchung der Sicherheit und Wirksamkeit von Ensinger Schiller Quelle Heilwasser bei funktioneller Obstipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to demonstrate the safety and efficacy of a healing
    water (Ensinger Schiller Quelle Heilwasser) on constipation compared to placebo
    Klinische Prüfung zur Untersuchung der Wirksamkeit und Sicherheit
    eines Heilwassers (Ensinger Schiller Quelle) bei Darmträgheit im Vergleich zu Plazebo
    A.4.1Sponsor's protocol code numberENS/007612
    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 SponsorEnsinger Mineral-Heilquellen 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 supportEnsinger Mineral-Heilquellen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEnsinger Mineral-Heilquellen GmbH
    B.5.2Functional name of contact pointThomas Fritz
    B.5.3 Address:
    B.5.3.1Street AddressHorrheimer Straße 28-36
    B.5.3.2Town/ cityVaihingen-Ensingen
    B.5.3.3Post code71665
    B.5.3.4CountryGermany
    B.5.4Telephone number004970422809610
    B.5.5Fax number004970422809449
    B.5.6E-mailthomas.fritz@ensinger.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 Ensinger Schiller Quelle Heilwasser
    D.2.1.1.2Name of the Marketing Authorisation holderEnsinger Mineral-Heilquellen 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 nameHeilwasser with the main ingredients calcium, magnesium, sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000 to 1000
    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 Yes
    D.3.11.13.1Other medicinal product typeEnsinger Schiller Quelle healing water is derived from two springs in Ensingen. It is enriched by minerals from dissolving rocks (dissolved main mineral substances: Calcium, Magnesium and Sulfate)
    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
    - Functional constipation according to the ROME III criteria
    - The subjects have bowel movements 2 - 4 days/week
    - Funktionale Darmträgheit nach ROME III Kriterien
    - Stuhlgang an 2 - 4 Tagen in der Woche
    E.1.1.1Medical condition in easily understood language
    constipation (bowel movement on 2 - 4 days per week)
    Verstopfung (Stuhlgang an 2 - 4 Tagen in der 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 16.1
    E.1.2Level LLT
    E.1.2Classification code 10029932
    E.1.2Term Obstipation
    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
    The main objective of the trial is the change of bowel movement frequency per week between baseline and visit 4 compared to placebo.
    Das Hauptzielkriterium ist die Veränderung der Stuhlfrequenz pro Woche zwischen Baseline und Visite 4 im Vergleich zu Placebo.
    E.2.2Secondary objectives of the trial
    • Change in the number of bowel movements per week
    • Change in the number of bowel movements during study duration
    • Change in stool consistency
    • Changes in gastrointestinal well-being
    • Change in general well-being
    • Change in liver and lipid metabolism function laboratory parameters
    • Change in gut flora parameters
    • Change in waist and hip circumference
    • Change in body weight and blood pressure
    • Global evaluation of efficacy by both investigators and subjects
    • Global evaluation of tolerability by both investigators and subjects
    • Safety laboratory parameters
    • Veränderung der Stuhlfrequenz pro Woche
    • Veränderung der Stuhlfrequenz im gesamten Studienverlauf
    • Veränderung der Stuhlkonsistenz
    • Veränderung des gastrointestinalen Wohlbefindens
    • Veränderung des allgemeinen Wohlbefindens
    • Veränderung der Parameter der Leberfunktion
    • Veränderung des Parameter des Fettstoffwechsels
    • Veränderung der Darmfloraparameter
    • Veränderung des Körpergewichtes
    • Veränderung von Bauch- und Hüftumfang
    • Veränderung des Blutdrucks
    • Globale Bewertung der Wirksamkeit durch Prüfer und Patienten zu Visite 4
    • Globale Bewertung der Verträglichkeit durch Prüfer und Patienten zu Visite 4
    • Sicherheitslaborparameter
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female and male subjects aged 18 - 64
    • BMI < 35 kg/m2
    • 2-4 bowel movements per week during the last 3 months (according to subject's statement)
    • Functional constipation according to the ROME III criteria
    • Commitment to adhere to former diet and physical activity
    • Subject is used to consuming at least 1000 ml of water (incl. tea) or mineral water daily
    • Commitment to only use the IP personally
    • Women of childbearing potential: commitment to use contraception methods
    • Participation is based upon written informed consent of the participant following written and oral information by the investigator regarding nature, purpose, consequences, and possible risks of the clinical trial
    • Alter: 18-64 Jahre
    • BMI < 35 kg/m2
    • Stuhlgang an 2-4 Tagen pro Woche während der letzten 3 Monate
    • Funktionelle Obstipation gemäß ROM III-Kriterien
    • Bereitschaft, Essgewohnheiten und körperliche Aktivität während der Studiendauer beizubehalten
    • Gewöhnt an täglichen Verzehr von mindestens 1 Liter Wasser (inkl. Tee) oder Mineralwasser
    • Bereitschaft, das Prüfpräparat ausschließlich zum eigenen Gebrauch zu nutzen
    • Bei gebärfähigen Frauen: sicherer Konzeptionsschutz
    • Schriftliche Einwilligung des Patienten nach erfolgter mündlicher und schriftlicher Aufklärung durch den Prüfer über Art, Zweck, Folgen und möglichen Risiken der klinischen Prüfung
    E.4Principal exclusion criteria
    • Clinically relevant excursions of laboratory parameters
    • Irritable bowel syndrom
    • Acute or chronic disease of the gastrointestinal tract
    • Presence of occult blood on screening
    • Abdominal surgery within the last 6 months prior to study start
    • Known pelvic floor dysfunction
    • Acute or chronic kidney or urinary tract disease
    • Susceptibility to development of uric acid or calcium-containing kidney stones
    • Acute or chronic neurological or psychiatric illness
    • Any serious organ or systemic diseases that could influence the
    outcome of the clinical trial
    • Known sensitivity to the ingredients of the product
    • Use of any preparations that could affect the gastrointestinal tract (e.g. probiotics, laxatives, enema, obstipating drugs etc.) during the last 2 weeks and during the study
    • Use of sympathomimetics and cardiac glycosides
    • Magnesium and Calcium supplementation during the study
    • Intake of mineral water other than the IP 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
    • Persons that are in relationship or dependence to the sponsor or the investigator
    • subject is a prisoner
    • Presence of other factor(s) that, in the in-vestigator’s judgement, should preclude subject participation.
    • Klinisch relevante Laborwertabweichungen
    • Reizdarmsyndrom
    • Akute oder chronische gastrointestinale Erkrankungen (z. B. Magen- oder Duodenalgeschwüre; chronisch entzündliche Darmerkrankung wie Colitis ulcerosa, Morbus Crohn etc.; maligne Erkrankungen, Darmverengungen, bekannte Darmpolypen etc.)
    • Blut im Stuhl
    • Viszeralchirurgische Eingriffe innerhalb der letzten 6 Monate
    • Lokale Erkrankungen am Darmausgang (z.B. Analfissur, Hämorrhoiden)
    • Gewichtsverlust von ≥ 6 kg in den letzten 6 Monaten vor Studienbeginn
    • Koronare Herzkrankheit/ Herzinfarkt/ Schlaganfall (anamnestische Angaben)
    • Essstörungen
    • Beckenbodenfehlfunktion
    • Diabetes mellitus
    • Schilddrüsenfunktionsstörung
    • Eingeschränkte Flüssigkeitsverträglichkeit bei Herz- oder Nierenerkrankungen
    • Neigung zur Bildung von Harnsäuresteinen und calciumhaltigen Harnsteinen
    • Akute oder chronische Nieren- und Harnwegserkrankung
    • Neurologische Erkrankungen (z. B. Multiple Sklerose, Schlaganfall, Verletzungen des Rückenmarks)
    • Akute oder chronische psychiatrische Erkrankungen (z.B. Depressionen)
    • Jede andere akute oder chronische Erkrankung, welche die Auswertung der Studie beeinflussen könnte
    • Bekannte Überempfindlichkeit gegenüber den Bestandteilen des Produkts
    • Anwendung von Präparaten gegen Verdauungsstörungen (z.B. Probiotika, Laxantien, Backpflaumen, Leinsamen, Einläufe etc.) innerhalb der letzten 14 Tage vor Studienbeginn oder während der Studie
    • Einnahme oraler Antibiotika innerhalb der letzten 4 Wochen vor Studienbeginn oder während der Studie
    • Einnahme von anderen Heilwässern während der Studie
    • Einnahme von magnesium- und calciumhaltigen Präparaten (Nahrungsergänzungsmitteln, EBD)
    • Schwangerschaft oder Stillzeit (bei gebärfähigen Frauen)
    • Alkohol-, Medikamenten- oder Drogenmissbrauch
    • Compliance nicht gewährleistet
    • Abhängigkeits-/Arbeitsverhältnis zum Sponsor oder Prüfer
    • Teilnahme an einer klinischen Prüfung innerhalb der letzten 30 Tage vor Studienbeginn
    • Patient ist auf gerichtliche oder behördliche Anordnung in einer Anstalt untergebracht
    • Vorliegen anderer Faktoren, die aus Sicht des Prüfers die Teilnahme des Patienten ausschließen
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the change of bowel movements per week, from baseline to visit 4 between verum and placebo
    Veränderung der Stuhlfrequenz pro Woche zwischen Baseline und Visite 4 im Vergleich zu Placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    The change of bowel movements per week will be assessed by comparison of the number of bowel movements in the week before Visit 4 and the week before baseline .
    Es wird die Stuhlfrequenz in der Woche vor der Baseline-Visite mit der Stuhlfrequenz in der Woche vor Visite 4 verglichen (mittels Patiententagebuch)
    E.5.2Secondary end point(s)
    • Change in the number of bowel movements per week compared to placebo
    • Change in the number of bowel movements during the study course compared to placebo
    • Change in stool consistency compared to placebo
    • Changes in gastrointestinal well-being compared to placebo
    • Change in general well-being compared to placebo
    • Change in liver and lipid metabolism function laboratory parameters compared to placebo
    • Change in body weight and blood pressure compared to placebo
    • Change in waist and hip circumference compared to placebo
    • Global evaluation of efficacy and tolerability by both investigators and subjects
    • Safety Laboratory parameters
    • Veränderung der Stuhlfrequenz pro Woche zwischen Baseline und Visite 3 im Vergleich zu Placebo. Hierzu wird die Stuhlfrequenz in der Woche vor der Baseline-Visite mit der Stuhlfrequenz in der Woche vor Visite 3 verglichen
    • Veränderung der Stuhlfrequenz im gesamten Studienverlauf
    • Veränderung der Stuhlkonsistenz zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo (mittels Bristol Stool Form Scale Fragebogen)
    • Veränderung des gastrointestinalen Wohlbefindens zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo mittels des Gastrointestinalen Lebensqualitätsindex (GLQI)
    • Veränderung des allgemeinen Wohlbefindens zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo mittels SF-12 Fragebogen
    • Veränderung der Parameter der Leberfunktion zwischen Screening-Visite und Visite 4 im Vergleich zu Placebo
    • Veränderung des Parameter des Fettstoffwechsels zwischen Screening-Visite und Visite 4 im Vergleich zu Placebo
    • Veränderung der Darmfloraparameter zwischen Screening-Visite und Visite 4 im Vergleich zu Placebo
    • Veränderung des Körpergewichtes zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo
    • Veränderung von Bauch- und Hüftumfang zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo
    • Veränderung des Blutdrucks zwischen Baseline und Visite 3 sowie Baseline und Visite 4 im Vergleich zu Placebo
    • Globale Bewertung der Wirksamkeit durch Prüfer und Patienten zu Visite 4
    • Globale Bewertung der Verträglichkeit durch Prüfer und Patienten zu Visite 4
    • Sicherheitslaborparameter
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Bowel movements frequency: Baseline and at V3
    • Bowel movements frequency: time course of the study (diary)
    • Stool consistency: Baseline and at V3/V4
    • Gastrointestinal well-being baseline and at V3/V4
    • General well-being: baseline and at V3/V4
    • Liver and lipid metabolism function laboratory parameters: baseline and at V3/V4
    • Gut flora parameters: screening Visit and at V4
    • Body weight/blood pressure: baseline and at V3/V4
    • Waist and hip circumference: baseline and at V3/V4
    • Global evaluation of efficacy and tolerability: V4
    • Laboratory parameters: screening Visit and V4
    • Stuhlfrequenz pro Woche: Baseline und V3
    • Stuhlfrequenz im gesamten Studienverlauf (Tagebuch)
    • Stuhlkonsistenz: Baseline und V3 sowie Baseline und V4
    • Gastrointestinales Wohlbefinden: Baseline und V3 sowie Baseline und V4
    • Allgemeines Wohlbefinden: Baseline und V3 sowie Baseline und V4
    • Parameter der Leberfunktion: V1 und V4
    • Parameter des Fettstoffwechsels: Screening-Visite und V4
    • Darmfloraparameter: Screening-Visite und V4
    • Körpergewicht: Baseline und V3 sowie Baseline und V4
    • Bauch- und Hüftumfang: Baseline und V3 sowie Baseline und V4
    • Blutdruck: Baseline und Visite 3 sowie Baseline und V4 im Vergleich zu Placebo
    • Globale Bewertung der Wirksamkeit: V4
    • Globale Bewertung der Verträglichkeit: V4
    • Sicherheitslaborparameter zu V1 und V4
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    LSLV
    LSLV
    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 months11
    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: 100
    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 state100
    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 of that condition.
    Nach der Teilnahme an der Studie, wird sich die Behandlung nicht von
    der herkömmlichen Behandlung von Darmträgheit 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 Decision2013-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-03
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