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    Summary
    EudraCT Number:2015-003293-32
    Sponsor's Protocol Code Number:Duski2015
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-12-01
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-003293-32
    A.3Full title of the trial
    Multicentre, Randomised, Placebo-Controlled Trial of Mebeverine in Children with Irritable Bowel Syndrome (IBS) or Functional Abdominal Pain - not otherwise specified (FAP-NOS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to investigate the effectiveness of mebeverine versus placebo in children with functional bowel disorders
    A.3.2Name or abbreviated title of the trial where available
    Duski
    A.4.1Sponsor's protocol code numberDuski2015
    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 SponsorAcademic Medical Center
    B.1.3.4CountryNetherlands
    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 supportAcademic Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointMarc Benninga
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205663053
    B.5.6E-mailm.a.benninga@amc.nl
    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 Duspatal
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott B.V. Hoofddorp
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameMebeverine
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule
    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 Gastrointestinal Disorders (Irritable Bowel Syndrome or Functional Abdominal Pain - not otherwise specified)
    E.1.1.1Medical condition in easily understood language
    Functional Bowel Disorders (Irritable Bowel Syndrome or Functional Abdominal Pain - not otherwise specified)
    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 LLT
    E.1.2Classification code 10064907
    E.1.2Term Functional abdominal pain
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    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
    Aim of this study is to determine the effect of mebeverine on abdominal pain intensity and frequency in children with irritable bowel syndrome or functional abdominal pain - not otherwise specified.
    E.2.2Secondary objectives of the trial
    To investigate the effect of mebeverine on other outcome parameters such as adequate relief, quality of life, depression and anxiety scores, and school absenteeism in children with irritable bowel syndrome or functional abdominal pain.
    To study the influence of labelling on the effect of both mebeverine and placebo on pain scores.
    To investigate the effect of reassurance, explanation and simple dietary and behavioural advice on abdominal pain intensity and frequency in children with irritable bowel syndrome or functional abdominal pain.
    To determine the safety of mebeverine in children with irritable bowel syndrome or functional abdominal pain.
    To study the effect of mebeverine on the faecal gut microbiota composition.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    All children aged between 12 and 18 years diagnosed with irritable bowel syndrome or functional abdominal pain – not otherwise specified according to the Rome IV criteria will be invited to participate. The Rome IV criteria form the internationally accepted standard for defining functional gastrointestinal disorders like irritable bowel syndrome and functional abdominal pain – not otherwise specified.1 Before inclusion, all patients undergo routine laboratory testing to exclude underlying organic disorders: complete blood cell count, C-reactive protein, celiac screening (anti-transglutaminase antibodies and IgA), fecal screening on Giardia lamblia if patient presents with diarrhea, and on calprotectin in case an Inflammatory Bowel Disease is suspected. The need for further diagnostic testing is left to the discretion of the treating physician.
    Finally, according to a recently published guideline by the Rome Foundation for the design of pharmacological clinical trials in children, patients are required to have an average daily pain rate of ≥2 on the Wong Baker Faces Pain Scale. This is a validated pain scale to measure pain intensity.
    In addition, Informed Consent by both parents and by children aged ≥ 12 years is a necessity before children can be included in the study.

    Rome IV criteria for irritable bowel syndrome (IBS) in children and adolescents:
    Diagnostic criteria* must include all of the following:
    - Abdominal pain at least 4 days per month associated with one or more of the following:
    a. Related to defecation
    b. A change in frequency of stool
    c. A change in form (appearance) of stool
    - In children with constipation, the pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome)
    - After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
    * Criteria fulfilled for at least 2 months before diagnosis

    Rome IV criteria for functional abdominal pain – not otherwise specified (FAP-NOS) in children and adolescents:
    Diagnostic criteria* must be fulfilled 4 times per month and include all of the following:
    1. Episodic or continuous abdominal pain that does not occur solely during physiologic events (e.g., eating, menses)
    2. Insufficient criteria for irritable bowel syndrome, functional dyspepsia, or abdominal migraine
    3. After appropriate evaluation, the abdominal pain cannot be fully explained by another medical condition.
    * Criteria fulfilled at least 2 months before diagnosis.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Current treatment by another health care professional for abdominal symptoms
    • Previous use of mebeverine
    • Known hypersensitivity to the active substance or to any of the excipients (magnesium stearate, polyacrylate dispersion, talc, hypromellose, methacrylic acid – ethyl acrylate copolymer (1:1) dispersion, glycerol triacetate, gelatine, titanium dioxide (E171), shellac (E904), propylene glycol, ammonia solution (concentrated), potassium hydroxide, iron oxide black (E172)).
    • Known diagnosis of cystic fibrosis
    • Known diagnosis of porphyria
    • Known concomitant organic gastrointestinal disease
    • Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, domperidone, and Iberogast.
    • Insufficient knowledge of the Dutch language
    • Known pregnancy or current lactation
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency after 8 weeks of drug therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    Twelve weeks and sixteen weeks after start at baseline
    E.5.2Secondary end point(s)
    Change in Quality of Life
    Change in depression and anxiety score
    Number of school absences during the treatment
    Use of pain rescue medication during the treatment (like paracetamol or NSAIDs)
    Health status
    Somatisation scores
    Expectancy of the treatment
    Change in IBS/ FAP symptoms on a 7 point scale (IBS-GAI)
    Adequate relief
    Effect of positive labelling
    Microbiota composition
    Safety of mebeverine use
    E.5.2.1Timepoint(s) of evaluation of this end point
    In the week before the start of the study, in the fourth week of the study, in the eight week of the study, in the twelfth week of the study and in the sixteenth week of the study.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 concerned7
    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
    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 months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 284
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 284
    F.1.2Adults (18-64 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children and adolescents below 18 years
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state284
    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)
    If patients did not experience adequate relief of IBS/FAP-NOS symptoms, they are offered psychological therapy. If patients experienced adequate relief of IBS/FAP-NOS symptoms with either mebeverine or placebo, they are offered mebeverine.
    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 Decision2015-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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