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    Summary
    EudraCT Number:2011-002613-10
    Sponsor's Protocol Code Number:STW5/212-D-011-III-V
    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:2011-10-17
    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 number2011-002613-10
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled study on the efficacy of Iberogast® (STW 5) in patients with irritable bowel syndrome
    Randomisierte, doppelblinde, placebokontrollierte Studie zur Wirksamkeit von Iberogast® (STW 5) in Patienten mit Reizdarmsyndrom (RDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study on the efficacy of Iberogast® (STW 5) in patients with irritable bowel syndrome
    Klinische Studie zur Wirksamkeit von Iberogast® (STW 5) bei Patienten mit Reizdarmsyndrom (RDS)
    A.3.2Name or abbreviated title of the trial where available
    Double-blind, placebo-controlled STW5 efficacy study in IBS patients
    Doppelblinde, Placebokontrollierte STW5 Wirksamkeitsstudie in RDS Patienten
    A.4.1Sponsor's protocol code numberSTW5/212-D-011-III-V
    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 SponsorSteigerwald Arzneimittelwerk 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 supportSteigerwald Arzneimittelwerk GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSteigerwald Arzneimittelwerk GmbH
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressHavelstraße 5
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64295
    B.5.3.4CountryGermany
    B.5.4Telephone number+4961513305189
    B.5.5Fax number+4961513305471
    B.5.6E-mailcareen.fink@bayer.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 Iberogast
    D.2.1.1.2Name of the Marketing Authorisation holderSteigerwald Arnzeimittelwerk 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 nameIberogast
    D.3.2Product code STW5
    D.3.4Pharmaceutical form Oral drops, 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 INNIberis Amara Extract
    D.3.9.2Current sponsor codeSTW5
    D.3.9.3Other descriptive nameIberis Amara Extract
    D.3.10 Strength
    D.3.10.1Concentration unit % (V/V) percent volume/volume
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    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 drops, 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
    Irritable Bowel Syndrome (IBS)
    Reizdarmsyndrom (RDS)
    E.1.1.1Medical condition in easily understood language
    Irritable Bowel Syndrome (IBS)
    Reizdarmsyndrom (RDS)
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    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
    The primary objective is to show the efficacy of STW 5 on pain related symptoms of patients with IBS.
    Das Primärziel der Studie ist die Wirksamkeit von Iberogast® (STW 5) in Bezug auf Abdominalschmerzen bei Patienten mit Reizdarmsyndrom.
    E.2.2Secondary objectives of the trial
    The secondary objective is to assess the safety and tolerability of STW 5 and to assess the effect of STW 5 on QoL.
    Sekundäre Studienziele sind die Beurteilung der Sicherheit und Verträglichkeit von Iberogast® (STW 5) sowie der Einfluß von STW 5 auf die Lebensqualität der Reizdarmpatienten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of either sex aged >18 years.
    2. Patients meeting the Rome III irritable bowel syndrome (IBS) diagnostic criteria. IBS is defined as recurrent abdominal pain or discomfort at least 3 days/month in last 3 months (onset at least 6 months ago) associated with two or more of the following: 1. Improvement with defecation, 2. Onset associated with a change in frequency of stool, 3. Onset associated with a change in form (appearance) of stool.
    3. History of pain intensity with a average of worst abdominal pain in past 24 hours score of > 30 on a daily measured VAS scale during screening phase (a minimum of 8 VAS values, assessed on different days during screening phase, is required).
    4. Patients willing to comply with the study protocol.
    5. Patients who are able to understand and provide written informed consent to participate in the trial (signed informed consent).
    1. Männliche oder weibliche Patienten im Alter von > 18 Jahren.
    2. Patienten müssen die Rom-III-Kriterien für die Diagnose Reizdarm erfüllen. Reizdarm ist definiert durch abdominale Schmerzen oder Unwohlsein an mindestens drei Tagen pro Monat während der vorangegangenen drei Monate, (Beginn vor
    mindestens sechs Monaten) mit mindestens zwei der folgenden Zeichen: a) Besserung durch Defäkation, b) Beginn mit Änderung der Stuhlfrequenz, c) Beginn mit Änderung von Stuhlkonsistenz und -aussehen.
    3. Patienten mit einer durchschnittlichen Intensität der stärksten Abdominalschmerzen innerhalb der letzten 24h von > 30% auf einer während der Screeningphase täglich beurteilten VAS (erforderlich sind mindestens 8 VAS-Werte ermittelt an
    unterschiedlichen Tagen).
    4. Patienten, die sich mit der Einhaltung des Studienprotokolls einverstanden erklären.
    5. Patienten, die in der Lage sind, die Einverständniserklärung zu verstehen und ihr Einverständnis schriftlich zu bestätigen.
    E.4Principal exclusion criteria
    1. Intake of STW 5 within the last 5 years.
    2. Concomitant treatment during the study (including screening phase) with any medication that could influence the gastrointestinal function (e.g. opiates, cyclic antidepressants (intake with stable dose since three months is tolerated),
    constipating drugs (e.g. medication against Parkinson Disease, Metformin, antipsychotic drugs, analgetics containing opiates, spasmolytics, laxatives, antidiarrheal agents). The use of provided rescue medication during the study treatment is permitted.
    3. Regular intake of nonsteroidal antiphlogistic drugs incl. COX-2-inhibitors (exception: acetylsalicylic acid for cardiovascular prevention up to 100 mg daily).
    4. Patients with known hypersensitivity to any component of the trial drugs.
    5. Severe allergic diathesis.
    6. Structural lesions or biochemical abnormalities that can be considered the cause of IBS symptoms.
    7. History of eating disorders.
    8. Patients with a history of diseases with abdominal symptoms that can resemble IBS, such as:
    - History of clinically relevant gastrointestinal disease such as gastric, pancreatic, colon or rectal cancer or gastric and/or duodenal ulcer.
    - Uncontrolled thyroid diseases (Hyper- or hypothyreosis).
    - Lactose intolerance with complete resolution of symptoms during lactose free diet.
    - Known inflammatory bowel diseases.
    - Known parasitic or bacterial infections.
    - Known malabsorption.
    - Known HIV infection.
    - Known endometriosis.
    - Pseudo-obstruction, myopathy, neuropathy.
    - Postsurgical syndromes.
    - Chronic pancreatitis.
    - Major psychiatric disorders.
    - Symptomatic biliary dysfunction or lithiasis.
    - History of food allergies and/or celiac sprue.
    9. Presence of any other acute or chronic gastrointestinal disorder.
    10. Patients with known severe acute or chronic diseases (i.e., cancer, tuberculosis).
    11. History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously).
    12. Mesenteric vascular diseases.
    13. Clinically relevant abnormalities in physical and/or biochemical findings at screening examination interfering with the study objectives.
    14. History of current or past alcohol or drug abuse.
    15. Known intolerance to azo dyes E 110 and E 151.
    16. Patients participating in a clinical trial within the last 30 days before Day 1 or with concurrent participation in another clinical trial.
    17. Any serious medical condition, which would hinder the patient’s ability to fully comply with the protocol.
    18. Female patients of childbearing potential with a positive pregnancy test, breast feeding, or female patients of childbearing potential without adequate contraception.
    19. The patient is institutionalized by court or administrative order.
    1. Einnahme von STW 5 innerhalb der letzten 5 Jahre.
    2. Begleitbehandlung mit Medikamenten während der Studie (einschließlich der Screeningphase), welche die gastrointestinale Funktion beinträchtigen, z.B. Opiate, zyclische Antidepressiva (regelmäßige Einnahme konstanter Dosen während der letzten 3 Monate ist erlaubt), Medikamente, die zu Verstopfungen führen (z.B. Medikamente gegen Morbus Parkinson, Metformin, Psychopharmaka, Opioid-Analgetika, Spasmolytika, Laxantien, Antidiarrhoika). Die Verwendung der für die Studie zur Verfügung gestellten Notfallmedikation ist erlaubt.
    3. Regelmäßige Einnahme von nicht-steroidalen, entzündungshemmenden Substanzen, einschließlich COX-2-Inhibitoren (Ausnahme: Acetylsalicylsäure zur kardiovaskulären Prävention in einer Dosierung bis zu 100mg täglich).
    4. Patienten mit einer bekannten Überempfindlichkeit gegen einen der Bestandteile der Prüfmedikationen.
    5. Patienten mit hoher Allergiebereitschaft.
    6. Strukturelle Läsion oder biochemische Abnormitäten, die als Ursache der RDSSymptome angesehen werden können.
    7. Patienten mit Eßstörungen.
    8. Patienten mit Erkrankung mit abdominalen Symptomen, die dem RDS ähneln können, z.B.:
    - Klinisch relevante gastrointestinale Erkrankungen wie Magen-, Pankreas-, Kolon- oder Mastdarmkrebs oder Magen- und/oder
    Zwölffingerdarmgeschwüre.
    - Unkontrollierte Schilddrüsenerkrankungen (Hyper- oder Hypothyreose).
    - Laktoseintoleranz mit vollständiger Symptomfreiheit bei laktosefreier Ernährung.
    - Bekannte chronisch-entzündliche Darmerkrankungen.
    - Bekannte parasitäre oder bakterielle Infektionen.
    - Bekannte Malabsorption.
    - Bekannte HIV Infektion.
    - Bekannte Endometriose.
    - Pseudoobstruktion, Myopathie, Neuropathie.
    - Postoperative Beschwerden.
    - Chronische Pankreatitis.
    - Schwerwiegende psychiatrische Störungen.
    - Symptomatische biliäre Dysfunktion oder Gallensteine.
    - Vorgeschichte von Lebensmittelallergien und/oder Zöliakie.
    9. Weitere akute oder chronische gastrointestinale Erkrankungen.
    10. Patienten mit bekannten schwerwiegenden akuten oder chronischen Erkrankungen (z.B. Krebs oder Tuberkulose).
    11. Vorgeschichte abdominaler chirurgischer Eingriffe (Cholezystektomie und Appendektomie können toleriert werden, wenn der Eingriff mehr als 1 Jahr zurück liegt).
    12. Mesenteriale Gefäßerkrankungen.
    13. Klinisch relevante Auffälligkeiten der physischen und/oder biochemischen Befunde während der Screeninguntersuchung, welche die Studienziele beeinträchtigen können.
    14. Aktueller oder ehemaliger Alkohol- oder Drogenmißbrauch.
    15. Bekannte Unverträglichkeit auf die Azofarbstoffe E 110 und E 151.
    16. Teilnahme an einer klinischen Studie innerhalb der letzen 30 Tage vor Studienbeginn (Tag 1) oder an einer gleichzeitig laufenden anderen Studie.
    17. Jede schwerwiegende medizinische Verfassung, welcher die Fähigkeit des Patienten beeinträchtigen würde, in vollem Umfang dem Studienprotokoll zu folgen.
    18. Weibliche Patienten im gebährfähigen Alter mit einem positiven Schwangerschaftstest, stillende Frauen oder Frauen im gebährfähigen Alter ohne adäquate Empfängnisverhütung.
    19. Eingewiesene oder inhaftierte Patienten.
    E.5 End points
    E.5.1Primary end point(s)
    Pain Intensity (Responder definition: Decrease of worst abdominal pain in past 24 hours score of ≥ 30% compared with Baseline for a least 14 single days during the treatment period of 4 weeks determined by daily assessment on a VAS)
    Schmerzintensität (Definition des Behandlungserfolges
    (Response): Abnahme des Wertes der stärksten
    Abdominalschmerzen innerhalb der letzten 24h um ≥ 30% im
    Vergleich zu dem Ausgangswert (Baseline) an mindestens
    14 einzelnen Tagen während der 4-wöchigen Behandlungszeit.
    Die Schmerzintensität wird täglich anhand einer VAS beurteilt)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain intensity will be assessed daily on a visual analog scale and entered in the patient diary. The diaries for the treatment period will be collected on Visit 3 and Visit 4 (2 weeks and 4 week after randomization)
    Schmerzintensität wird täglich gemessen mittels einer visuellen analog Skala und im Patiententagebuch eingetragen. Die Tagebücher der Behandlungsphase werden zu Visite 3 und zu Visite 4 (2 Wochen und 4 Wochen nach Randomisierung) eingesammelt.
    E.5.2Secondary end point(s)
    - Pain Intensity (Responder definition: Decrease of worst abdominal pain in past 24 hours score of ≥ 30% compared with Baseline for at least 7 single days within the first 2 weeks of study treatment determined by daily assessment on a VAS)
    - Stool parameters (stool consistency and stool frequency)
    - Irritable Bowel Syndrome – Quality of Life Measure (IBS_QOL)
    - Schmerzintensität (Definition des Behandlungserfolges
    (Response): Abnahme des Wertes der stärksten
    Abdominalschmerzen innerhalb der letzten 24h um ≥ 30% im
    Vergleich zu dem Ausgangswert (Baseline) an mindestens
    7 einzelnen Tagen während der ersten 2 Wochen der
    Behandlungszeit. Die Schmerzintensität wird täglich anhand
    einer VAS beurteilt)
    - Stuhlparameter (Frequenz und Konsistenz)
    - RDS-Lebensqualität-Fragebogen (IBS-QOL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Pain intensity will be assessed daily on a visual analog scale and entered in the patient diary. The diary for the treatment period will be collected on Visit 3 (2 weeks after randomization)
    - Stool parameters will be assessed daily in the patientdiary
    - Irritable Bowel Syndrome – Quality of Life Measure will be asseseed on Visit 2 (Randomization) and Visit 4 (final Study visit)
    - Schmerzintensität wird täglich gemessen mittels einer visuellen analog Skala und im Patiententagebuch eingetragen. Das Tagebuch der Behandlungsphase wird zu Visite 3 (2 Wochen nach Randomisierung) eingesammelt.
    - Stuhlparameter (Frequenz und Konsistenz) werden täglich ermittelt und im Tagebuch vermerkt
    - RDS-Lebensqualität-Fragebogen (IBS-QOL) wird zu Visite 2 (Randomisierung) und Visite 4 (Abschlußbesuch) erhoben
    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) 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned20
    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
    Study end is defined as database hard lock in 2018.
    Studienende ist definiert als Datenbankschluss 2018.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 37
    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 state237
    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)
    Normal treatment for that condition continues.
    Die normale Behandlung für diese Erkrankung wird fortgesetzt.
    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 Decision2011-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-25
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