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    Summary
    EudraCT Number:2016-002110-42
    Sponsor's Protocol Code Number:PHRCIR2015DAPOIGNY
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-05-28
    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 ConcernedFrance - ANSM
    A.2EudraCT number2016-002110-42
    A.3Full title of the trial
    Evaluation of the effectiveness and safety of ethosuximide in the treatment of abdominal pain associated with irritable bowel syndrome
    Evaluation de l’efficacité et de la tolérance de l’éthosuximide dans le traitement de la douleur abdominale liée au syndrome de l’intestin irritable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of ethosuximide in the treatment of irritable bowel syndrome
    Efficacité de l'éthosuximide dans le traitement du syndrome de l'intestin irritable
    A.3.2Name or abbreviated title of the trial where available
    IBSET
    IBSET
    A.4.1Sponsor's protocol code numberPHRCIR2015DAPOIGNY
    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 SponsorCHU CLERMONT-FERRAND
    B.1.3.4CountryFrance
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointclinical trial information
    B.5.3 Address:
    B.5.3.1Street AddressVilla annexe IFSI CHU de Clermont-Ferrand 58, rue Montalembert
    B.5.3.2Town/ cityclermont-ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number+330473751195
    B.5.5Fax number+330473754730
    B.5.6E-mailplacarin@chu-clermontferrand.fr
    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 ZARONTIN
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Syrup
    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.3.9.3Other descriptive nameETHOSUXIMIDE
    D.3.9.4EV Substance CodeSUB07282MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboSyrup
    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
    abdominal pain related to irritable bowel syndrome
    douleur abdominale associée au syndrome de l'intestin irritable
    E.1.1.1Medical condition in easily understood language
    irritable bowel syndrome
    syndrome de l'intestin irritable
    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
    Evaluation of the effectiveness and safety of ethosuximide on the abdominal discomfort / pain and felt on the effectiveness of treatment of patients with IBS
    Evaluation de l'efficacité et de la tolérance de l’éthosuximide sur la gêne/douleur abdominale et du ressenti sur l’efficacité du traitement des patients atteints du SII
    E.2.2Secondary objectives of the trial
    Ethosuximide impact on the quality of life of patients, severity of symptoms related to IBS, its tolerance, the stop rate and the consumption of analgesics / antispasmodic / transit regulators .
    Impact de l’éthosuximide sur la qualité de vie des patients, la sévérité des symptômes liés au SII, sa tolérance, le taux d’arrêt et la consommation d’antalgiques/antispasmodiques/régulateurs du transit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age ≥ 18 years,
    -Man,
    -Women, negative pregnancy test and effective contraception,
    -SII defined by the Rome IV
    -During the seven days preceding the inclusion visit, NRS discomfort / pain average ≥ 4,
    -Treatment for IBS stable for 1 month,
    -Patients affiliated to the regime of the French Social Security,
    -Patients with the free and informed consent was obtained.
    -Age ≥ 18 ans,
    -Homme,
    -Femme, test de grossesse négatif et contraception efficace,
    -SII défini par les critères de Rome IV,
    -Durant les 7 jours précédents la visite d’inclusion, ENS gêne/douleur moyenne ≥ 4,
    -Traitement pour le SII stable depuis 1 mois,
    -Patients affiliés au régime de la Sécurité Sociale française,
    -Patients dont le consentement libre et éclairé a été recueilli.
    E.4Principal exclusion criteria
    breastfeeding
    Chronic pain condition equal or greater in severity than the pain related to IBS
    diabetic patients
    known renal or hepatic impairment
    significant liver function abnormalities (transaminases> 3N, cholestasis) and renal (MDRD <60 ml / min)
    Addiction to alcohol and / or drugs
    Taking antiepileptic family carboxamides, and ethosuximide
    Allergy succinimides (ethosuximide, methsuximide, phensuximide)
    severe depression or current history (hospitalization, antidepressants long term)
    psychotic disorders
    Antiepileptic drugs
    Patients exclusion period, or total compensation exceeded permitted
    Patients undergoing a measure of legal protection (trusteeship, guardianship ...).
    -Allaitement,
    - Douleur chronique d'intensité supérieure à celle liée au SII
    -Patients diabétiques,
    -Insuffisance rénale ou hépatique connue,
    -Anomalies significatives du bilan hépatique (transaminases > 3N, cholestase), et rénal (MDRD < 60 ml/min),
    -Dépendance à l’alcool et/ou aux stupéfiants,
    -Prise d’antiépileptiques de la famille des carboxamides, et éthosuximide
    -Allergie aux succinimides (éthosuximide, méthsuximide, phensuximide),
    -Antécédents de dépression sévère ou en cours (hospitalisation, traitement antidépresseur de longue durée),
    -Troubles psychotiques,
    - Utilisation d'antiépileptiques,
    -Patients en période d’exclusion, ou total d’indemnités autorisées dépassé,
    -Patients bénéficiant d’une mesure de protection légale (curatelle, tutelle…).
    E.5 End points
    E.5.1Primary end point(s)
    treatment responder rate:
    (From Guidelines EMA / CHMP / 60337/2013 - CPMP / EWP / 785/97 Rev. 1: for short treatment on all types of SII)

    A responder will correspond to a reduction in the score of the abdominal pain of at least 30% compared to the score before treatment and a score of 6 or 7 on the scale SGA. At study end, it will be compared the responder rate between the 2 treatment arms (ethosuximide vs placebo).

    Abdominal discomfort / pain:
    Percentage of difference (Δ) between the mean intensity abdominal pain assessed daily by NRS during the last 7 days before the start of treatment and the end of treatment: Δ = NRS score (D0) - NRS score (D0 + 12 weeks)

    Felt of the patient on the effectiveness of treatment:
    The Subject Global Assessment of Relief (SGA) is to evaluate the effectiveness of a specific treatment on symptoms of IBS. This scale consists of 7 levels of description answering the question “How would you rate your relief of IBS symptoms (abdominal discomfort/pain, bowel habits, and other IBS symptoms) over the past week compared with how you felt before you entered the study?”.
    Taux de répondeurs au traitement :
    (D’après Guidelines EMA/CHMP/60337/2013 - CPMP/EWP/785/97 Rev. 1 : pour traitement court sur tous types de SII)

    Un répondeur correspondra à une diminution du score de la douleur abdominale d’au moins 30% en comparaison du score avant traitement ET un score de 6 ou 7 sur l’échelle SGA. En fin d’étude, il sera comparé le taux de répondeurs entre les 2 bras de traitement (éthosuximide vs placebo).

    Gêne/douleur abdominale :
    Pourcentage de différence (Δ) entre la moyenne de l’intensité de la douleur abdominale évaluée quotidiennement par une ENS lors des 7 derniers jours précédant le début du traitement et la fin de traitement: Δ = score ENS (J0) – score ENS (J0+12 semaines)

    Ressenti du patient sur l’efficacité du traitement :
    Le Subject Global Assessment of Relief (SGA) a pour but d'évaluer l'efficacité d'un traitement spécifiquement sur les symptômes du SII. Cette échelle consiste en 7 niveaux de description répondant à la question « Comment évalueriez-vous le soulagement de vos symptômes du SII (gêne / douleur abdominale, transit intestinal et autres symptômes du SII) au cours de la dernière semaine écoulée par rapport à la façon dont vous vous êtes senti avant l'entrée dans l'étude? ».
    E.5.1.1Timepoint(s) of evaluation of this end point
    start of the study (D0) and the end of study (D0+12weeks)
    début de l’étude (J0) et fin d’étude (J0+12semaines)
    E.5.2Secondary end point(s)
    - Evaluation of daily abdominal pain (NRS) each week before the visits,
    - Monthly evaluation of the quality of life of patients by GIQLI and EQ-5D questionaires,
    - Monthly evaluation of the severity of symptoms by Francis questionnaire (IBS-SSS) and daily evaluation for the Bristol scale each week before the visits,
    - Monthly evaluation of the overall patient felt on the effectiveness of treatment (SGA)
    - Evaluation of the use of analgesics / antispasmodic / transit regulators ,
    - Evaluation of medical response rate and work stoppage related to IBS,
    - Evaluation of tolerance and the discontinuation rate study because of adverse events.
    -Evaluation journalière de la douleur abdominale (ENS) chaque semaine précédant les visites,
    -Evaluation mensuelle de la qualité de vie des patients par le questionnaire GIQLI et EQ-5D,
    -Evaluation mensuelle de la sévérité des symptômes par le questionnaire de Francis (IBS-SSS) et évaluation journalière pour l’échelle de Bristol chaque semaine précédant les visites,
    -Evaluation mensuelle du ressenti global du patient sur l’efficacité du traitement (SGA),
    -Evaluation de la consommation d’antalgiques/antispasmodiques/régulateurs du transit,
    -Evaluation du taux d’intervention médicale et d’arrêt de travail liés au SII,
    -Evaluation de la tolérance et du taux d’arrêt d’étude pour cause d’évènement indésirable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    daily or monthly
    quotidiennement ou mensuellement
    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 No
    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 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 concerned11
    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
    DVDS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 286
    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 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 state286
    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
    aucun
    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 Decision2017-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-03-07
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