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    Summary
    EudraCT Number:2013-001199-39
    Sponsor's Protocol Code Number:MulticenterEbastineIBS
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-001199-39
    A.3Full title of the trial
    Histamine 1 receptor antagonist ebastine as novel treatment in IBS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Blocking the histamine 1 receptor by ebastine as a novel treatment in IBS
    A.4.1Sponsor's protocol code numberMulticenterEbastineIBS
    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 SponsorKULeuven
    B.1.3.4CountryBelgium
    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 supportKULeuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKULeuven
    B.5.2Functional name of contact pointTARGID
    B.5.3 Address:
    B.5.3.1Street AddressHerestraat 49 box 701
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-maildafne.balemans@med.kuleuven.be
    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 Ebastine TEVA
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharma Belgium N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameEbastine
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNEbastine
    D.3.9.1CAS number 90729-43-4
    D.3.9.3Other descriptive nameEBASTINE
    D.3.9.4EV Substance CodeSUB06435MIG
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    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
    Patients who suffer from irritable bowel syndrome which are diarrhea predominant and mixed (alteration of constipation and diarrhea)
    E.1.1.1Medical condition in easily understood language
    Patients who suffer from irritable bowel syndrome which are diarrhea predominant and mixed (alteration of constipation and diarrhea)
    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
    Global symptom relief and relief of abdominal pain
    E.2.2Secondary objectives of the trial
    Other IBS symptoms and quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients must meet the Rome III criteria for Irritable Bowel Syndrome:
     3 days per month, continuous or not, in the last 3 months have abdominal discomfort or pain, with at least two of the following three characteristics:
    - Reducing after defecation, and / or
    - associated with a change in frequency of stool, and / or
    - associated with a change of consistency / shape of the stool
    2. No identifiable organic explanation for the symptoms (including the execution of a test for lactose intolerance, celiac disease and giardia test)
    3. Age 18-65 years
    4. Signed informed consent
    5. Symptoms during the two weeks of screening
    1. Patiënten moeten voldoen aan de Rome III criteria voor Prikkelbare Darm Syndroom:
     3 dagen per maand, al dan niet aaneengesloten, in de afgelopen 3 maanden van abdominaal ongemak of pijn, met tenminste 2 van de volgende 3 kenmerken:
    - Verminderend na defaecatie; en/of
    - geassocieerd met een verandering van ontlasting frequentie; en/of
    - geassocieerd met en verandering van consistentie / vorm van de ontlasting
    2. Geen aanwijsbare organische verklaring voor de klachten (met inbegrip van het uitvoeren van een lactose intolerantie test, coeliakie en giardia test)
    3. Leeftijd 18-65 jaar
    4. Getekend informed consent
    5. Symptomen gedurende twee screeningsweken
    E.4Principal exclusion criteria
    1. IBS constipation dominant
    2. Patient with history of:
    Celiac disease, Known milk allergy, giardiasis, inflammatory bowel disease, active intestinal infection, chronic intestinal ischemia, chronic subobstruction, pseudo-obstruction, dumping syndrome, pancreatic insufficiency, hepatic impairment, renal function impairment, cardiovascular disease, extensive gastrectomy and/or bowel resection, active malignant disease, thyroiddysfunction, insulin dependent diabetes mellitus, psychiatric disorder, any clinical condition in which the researcher does not allow to terminate the study safely
    3. Pregnancy, lactation
    4. Medication: Use of anti-allergica, antidepressants, and antipsychotics
    5. Patient uses drugs that reduce gastrointestinal motility and / or affect the visceral perception (anticholinergics, antispasmodics, 5-HT4 agonists, cholinomimetics, loperamide, laudanum, codeine, stimulant laxatives, macrogol, paraffin oil, analgesics).
    6. Complaints arise after abdominal surgery
    1. PDS obstipatie dominant
    2. Patiënt met geschiedenis van:
    Coeliakie, Gekende melkallergie, Giardiasis, inflammatoire darmziekte, actieve intestinale infectie, chronische darmischemie, chronische subobstructie, pseudo-obstructie, dumping syndroom, pancreasinsufficiëntie, leverfunctiestoornis, nierfuntiestoornis, cardiovasculaire aandoening, uitgebreide maagdarmresecties, actieve maligne aandoening, schildklierdysfunctie, Insuline dependente diabetes mellitus, psychiatrische aandoening, elke klinische conditie die volgens de onderzoeker niet toelaat veilig de studie te beëindigen
    3. Zwangerschap, borstvoeding
    4. Medicatie: gebruik van anti-allergica, antidepressiva en antipsychotica
    5. Patiënt gebruikt farmaca die de gastrointestinale motiliteit en/of de viscerale perceptie beïnvloeden (anticholinergica, spasmolytica, 5-HT4 agonisten, cholinomimetica, loperamide, laudanum, codeïne, stimulerende laxativa, macrogol, parafine olie, analgetica).
    6. Klachten ontstaan na buikoperatie
    E.5 End points
    E.5.1Primary end point(s)
    Global relief of symptoms and a decrease in abdominal pain
    E.5.1.1Timepoint(s) of evaluation of this end point
    every week after the start with the medication
    E.5.2Secondary end point(s)
    other IBS-symptoms (stool frequency and consistency, urgency, bloating, etc.) and quality of life
    E.5.2.1Timepoint(s) of evaluation of this end point
    IBS-symptoms: every week after the start with the medication
    quality of life: 6, 12 and 14 weeks after the start with the medication
    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) 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Trial ends after three months of intake of study medication. If participants stop earlier with study medication intake, the are excluded from the study
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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) 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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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
    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 Decision2013-10-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-11-02
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