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    Summary
    EudraCT Number:2017-003258-18
    Sponsor's Protocol Code Number:DOMINO
    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:2018-01-11
    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 number2017-003258-18
    A.3Full title of the trial
    A randomized controlled trial to evaluate the short-term efficacy and long-term health economic impact of a dietary intervention compared to pharmacotherapy with a musculotropic spasmolytic agent for newly diagnosed or newly treated irritable bowel syndrome in primary care.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized study to evaluate the short-term efficacy and long-term health economic impact of diet compared to a medication for patients with irritable bowel syndrome.
    A.3.2Name or abbreviated title of the trial where available
    The DOMINO trial: Diet Or Medication in Irritable bowel syNdrOme
    A.4.1Sponsor's protocol code numberDOMINO
    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 SponsorUniversity Hospital Leuven
    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 supportUniversity Hospital Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Leuven
    B.5.2Functional name of contact pointFlorencia
    B.5.3 Address:
    B.5.3.1Street AddressCarbone
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number003216345190
    B.5.6E-mailflorencia.carbone@uzleuven.be
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Spasmomen
    D.2.1.1.2Name of the Marketing Authorisation holderMenarini Industrie Farmaceutiche Riunite Srl Via Sette Santi 3, 50131 Florence, Italy
    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 nameOtilonium Bromide
    D.3.4Pharmaceutical form 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 INNOTILONIUM BROMIDE
    D.3.9.1CAS number 26095-59-0
    D.3.9.4EV Substance CodeSUB09479MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    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); relief of abdominal pain, distension and motility disorders
    characterised by smooth muscle spasm.
    E.1.1.1Medical condition in easily understood language
    relief of abdominal pain, distension and abdominal cramps. Improve symptoms of constipation or 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
    The primary outcome is the improvement in IBS-Symptom Severity Score after 8 weeks of otilonium bromide compared to dietary intervention, with a 50-point drop being the established cut-off used in clinical trials. Based on our clinical experience and the available clinical data, we hypothesize that the dietary intervention will be superior to treatment with otilonium bromide 40 mg t.i.d. in improving IBS-SSS.
    E.2.2Secondary objectives of the trial
    As a secondary hypothesis, we propose that initial treatment with diet, compared to medication, generates less health economic costs over a 6-months follow-up period.
    Healthcare resource utilization (HRU) related to IBS (medical consultations, diagnostic tests, therapies, hospitalizations, management of adverse reactions) will be collected using an ad-hoc questionnaire. Retrospective HRU data will be collected at the baseline visit for up to a maximum of 6 months for direct costs and 3 months for indirect costs. Prospective HRU are collected during routine follow-up at 2, 4 and 6 months/Early Termination. At the same time points, we will also assess the impact of IBS on work productivity using the Work Productivity and Activity Impairment (WPAI) questionnaire-irritable bowel syndrome version. We will also evaluate quality of life using a syndrome-specific instrument (IBSQOL) as well as the generic EuroQol instrument.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible patients are those of either gender, above the age of 18, eligible to give informed consent, newly diagnosed with or newly to be treated for IBS in primary care, as this is the setting where the majority of these patients is managed. The diagnostic gold standard, in line with clinical practice, will be clinician’s diagnostic judgment. However, to support the diagnosis and make it more uniform, a Rome IV-based diagnostic questionnaire with pictograms and a list of alarm symptoms will also be included in the CRF at the initial visit, and guidance for diagnosis and potentially useful additional tests will be provided at the investigator meetings, based on the Rome IV management algorithm. Patients who did not receive treatment over the preceding 4 months, and who did not receive long-term treatment (>3 consecutive weeks) with otilonium bromide in the past are eligible for the trial. Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study.
    E.4Principal exclusion criteria
    Exclusion criteria applies to the following points:
    • Patients not capable to understand or be compliant with the study.
    • Patients with concurrent organic gastrointestinal disease (inflammatory bowel disease), a history of major bowel surgery (not including minimal invasive surgery such as appendectomy or cholecystectomy, but including sigmoidectomy, hemicolectomy and small bowel resections)
    • Patients who received treatment with otilonium bromide in the past for more than 3 weeks consecutively or who received otilonium bromide recently for any duration in the last 3 months.
    • Patients who have used FODMAP or NICE diet before.
    • Patients who recently (last 3 weeks) used other medication for IBS, or who changed their diet for IBS or for any other reason over the last 3 months. To be included in the trial patients should stop these treatments following the advice of their GP (see paragraph 8.9).
    • Patients with diabetes, uncontrolled thyroid disease, active malignant disease (not including patients with cancer free diagnosis for more than 5 years), symptomatic uncontrolled endometriosis.
    • Patients with a major psychiatric disease. The use of a single antidepressant on a stable dose for at least 3 months is allowed (see paragraph 8.9).
    • Patients with drug abuse and/or alcohol abuse.
    • Patients on pharmacologically prepared probiotic formulations (i.e. bought in the pharmacy) will be excluded. The use of probiotic drinks or yoghurts available from food stores, such as Activia®, Yakult ®, Actimel ®, is allowed but should be registered as “complementary treatment”(see paragraph 8.9).
    • Women with active pregnancy plans in the coming 6 months are not eligible and women of childbearing potential are only eligible if they use effective contraception throughout the study. Also excluded are women of childbearing potential not using effective contraception or women planning to become pregnant the next 6 months (see paragraph 8.9 of the protocol). Methods of contraception considered highly effective are: combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, a vasectomized partner or sexual abstinence (http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf).
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is based on the improvement of the IBS-SSS score from baseline after 8 weeks of treatment. A responder is defined as a patient who has an improvement with 50 points or more on this validated scale after 8 weeks of treatment compared to baseline.
    The IBS-SSS is a validated and easy-to-use score for IBS symptom severity, and has been used in multiple international studies. The questionnaire is available in validated Dutch and French versions. The severity score is calculated as the sum of five IBS-SSS questions that are scored from 0 to 100. The baseline score serves as a severity grading, with moderate severity in case of a score between 175 and 300 and severe symptoms in case of a score above 300. Response is defined as a drop of more than 50 points compared to baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    E.5.2Secondary end point(s)
    Secondary endpoints are the improvement of the IBS-SSS score from baseline after 4 weeks of treatment (short term treatment response after 4 weeks is relevant for clinical practice), and at the follow-up visits of 4 and 6 months (long-term treatment outcome in terms of symptom control). The mean IBS-SSS scores will be collected at these time points to indicate magnitude of symptom improvement, taking into account that treatment modalities after 8 weeks may vary as this is then left to the discretion of the patient and the GP.
    E.5.2.1Timepoint(s) of evaluation of this end point
    8 weeks
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Pragmatic trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Diet
    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 concerned101
    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 would be after 8 weeks of treatment. After these 8 weeks the patient is free to be followed up for another 16 weeks. In this case, the LVLS would be after 24 weeks.
    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 months
    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 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: 470
    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 state470
    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)
    no
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Domino trial investigators
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-11-14
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