Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2009-013049-27
    Sponsor's Protocol Code Number:FMTO901
    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:2009-09-04
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-013049-27
    A.3Full title of the trial
    Evaluation de l’intérêt thérapeutique de MeteoSpasmyl ® administré à la demande dans la prise en charge du syndrome de l’intestin irritable.
    A.4.1Sponsor's protocol code numberFMTO901
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMAYOLY-SPINDLER
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Meteospasmyl
    D.2.1.1.2Name of the Marketing Authorisation holderMayoly-Spindler
    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 Capsule, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNALVERINE (DCI) CITRATE
    D.3.9.1CAS number 5560-59-8
    D.3.9.3Other descriptive nameALVERINE CITRATE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSIMETICONE (DCI)
    D.3.9.1CAS number 8050-81-5
    D.3.9.3Other descriptive nameSIMETICONE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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.IMP: 2
    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.2.5The 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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMP
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Information not present in EudraCT
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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
    Syndrome de l'intestin irritable
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10023003
    E.1.2Term Irritable bowel syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    L’objectif principal de cette étude est de comparer l’intérêt thérapeutique (effectiveness) de deux stratégies thérapeutiques dans la prise en charge de patients adultes présentant un syndrome de l’intestin irritable diagnostiqué selon les critères de ROME III.
    Stratégie A = MeteoSpasmyl ®, pris par le patient à la demande dans le but d’un bénéfice qu’il considère comme optimal.
    Stratégie B = choix thérapeutique habituellement utilisé par l'investigateur dans le but d'obtenir pour son patient le bénéfice thérapeutique optimal. Aucun traitement ni aucune option thérapeutique spécifique ne sont recommandés.
    L’évaluation de l’intérêt thérapeutique sera fondée sur l’évolution d’un score de qualité de vie obtenu par la passation de l’échelle IBS Qol.
    E.2.2Secondary objectives of the trial
    • Comparer l’évolution des différentes dimensions de l’échelle de qualité de vie IBS Qol
    • Comparer l’évolution de la qualité de vie évaluée sur l’échelle non spécifique SF36 (analyse du score global et analyse par dimension)
    • Comparer la fréquence et l’intensité moyenne des manifestations douloureuses pendant la durée du suivi
    • Dépister la présence de symptômes anxieux ou dépressifs, évaluer leur fréquence et comparer leur évolution dans les deux groupes
    • Evaluer le retentissement de la maladie sur la qualité du sommeil et comparer son évolution dans les deux groupes
    • Comparer les coûts de prise en charge (coûts directs + coûts des arrêts de travail)
    • Evaluer la consommation conjointe d’antalgiques et de psychotropes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Homme ou femme de plus de 18 ans, ambulatoire ayant lu, compris, daté et signé le consentement éclairé
    • Présentant depuis plus de 1 an et moins de 6 ans un syndrome de l’intestin irritable défini selon les critères de ROME III
    • Consultant pour une poussée douloureuse modérément sévère (score de C.Y. FRANCIS compris entre 175 et 400) justifiant une prise en charge thérapeutique
    • Ayant bénéficié d’au moins une exploration colique ayant éliminé une autre cause pouvant expliquer les symptômes
    • Patient pour lequel un suivi de six mois est envisageable
    E.4Principal exclusion criteria
    1- Les patients présentant l’une des caractéristiques suivantes ne peuvent être inclus dans l’essai :
    • Patient asymptomatique
    • Diarrhée aiguë ou un trouble du transit associé à un fécalome, une maladie des laxatifs, des troubles digestifs associés à une pathologie organique (tumeur, polypose, diverticulose compliquée, maladie de Crohn, RCH...)
    • Patient ayant reçu un traitement par MeteoSpasmyl ® au cours de l’année écoulée
    • Antécédent de chirurgie digestive datant de moins de 18 mois (sauf appendicectomie, cure de hernie)
    • Affection endocrinienne non controlée (hypo ou hyperthyroïdie, hyperparathyroïdie, diabète insulino-dépendant)
    • Femme enceinte, en période de lactation ou en âge de procréer et qui n’utilise pas de méthode contraceptive efficace
    • Déficience mentale ou toute autre raison pouvant gêner la stricte application du protocole
    • Patient susceptible de ne pas revenir aux visites de contrôle
    • Patient déjà inclus dans un autre protocole d’étude thérapeutique ou ayant participé à un autre essai dans les trois mois précédents

    2- Les patients présentant une allergie connue ou hypersensibilité à l’un des composants de Météospasmyl ® ne peuvent être inclus dans le groupe Météospasmyl (stratégie A).
    E.5 End points
    E.5.1Primary end point(s)
    Le critère utilité est défini comme le pourcentage d’amélioration (ou d’aggravation) de l’échelle de qualité de vie spécifique IBS-QOL entre J0 et l’évaluation finale.

    Critères d’évaluation cliniques
    Echelle de qualité de vie spécifique : Echelle IBS-QOL
    Echelle de qualité de vie générique : Echelle SF36
    Evaluation des troubles affectifs : Echelle HAD
    Evaluation de la somnolence diurne : Questionnaire d’EPWORTH
    Evaluation des symptômes : Score de C.Y.FRANCIS
    Autoévaluation quotidienne de la douleur abdominale


    Critères d’évaluation économiques
    Chiffrage des coûts directs
    Les actes de soins et les examens complémentaires seront évalués selon la nomenclature sur la base des honoraires conventionnés
    Le coût des médicaments sera évalué en fonction du prix mentionné sur le Vidal 2009
    Le coût des hospitalisations sera calculé en fonction de la durée du séjour et sur la base du prix moyen de la journée d’hospitalisation à l’assistance publique de Marseille

    Chiffrage des coûts indirects
    Le coût des journées d’arrêt de travail sera calculé à partir du revenu net moyen par profession publié par l’INSEE (annexe 2 du protocole).
    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 Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Groupe comparateur traité selon le choix thérapeutique habituellement utilisé par l'investigateur
    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 concerned125
    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 Information not present in EudraCT
    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
    L'essai sera terminé à la date de la dernière visite du dernier patient inclus.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state500
    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)
    LE PROTOCOLE NE PREVOIT PAS DE SOIN POUR LES PERSONNES A LA FIN DE LEUR PARTICIPATION A L'ESSAI
    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 Decision2009-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-06
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Wed May 01 21:48:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA