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    Summary
    EudraCT Number:2013-003328-35
    Sponsor's Protocol Code Number:CHD062-13
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 number2013-003328-35
    A.3Full title of the trial
    Efficacité de la Silodosine dans la Thérapie Médicale Expulsive des Calculs urétéraux pelviens de 4 à 10 mm. Etude randomisée.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacité de la Silodosine dans la Thérapie Médicale Expulsive des Calculs urétéraux pelviens de 4 à 10 mm. Etude randomisée.
    A.3.2Name or abbreviated title of the trial where available
    SiloMET
    A.4.1Sponsor's protocol code numberCHD062-13
    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 SponsorCentre Hospitalier Départemental Vendée
    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 supportCentre Hospitalier Départemental Vendée
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Départemental Vendée
    B.5.2Functional name of contact pointAUZANNEAU Lucie
    B.5.3 Address:
    B.5.3.1Street AddressBd Stéphane Moreau
    B.5.3.2Town/ cityLa Roche sur Yon
    B.5.3.3Post code85925
    B.5.3.4CountryFrance
    B.5.4Telephone number+330251446380
    B.5.5Fax number+330251446298
    B.5.6E-maillucie.auzanneau@chd-vendee.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 Urorec 8 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRecordati Ireland Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameUrorec
    D.3.4Pharmaceutical form Capsule
    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 INNSilodosin
    D.3.9.1CAS number 160970-54-7
    D.3.9.3Other descriptive nameSILODOSIN
    D.3.9.4EV Substance CodeSUB23152
    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
    patient admis pour un épisode de colique néphrétique sans signes de complication avec un calcul unique
    E.1.1.1Medical condition in easily understood language
    colique néphrétique, calculs urétéraux pelviens
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10038528
    E.1.2Term Renal stone removal
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Augmentation du taux d’expulsion spontanée des calculs pelviens de 4 à 10 mm. (Moyenne sans traitement alphabloquant = 50% , Valeur cible = 75%) dans le groupe Silodosine par rapport au groupe de référence.
    E.2.2Secondary objectives of the trial
    Diminution de la douleur.
    Raccourcissement du délai d’expulsion.
    Diminution de la consommation de soins (hospitalisations, consultations, actes chirurgicaux).
    Diminution du nombres de journées d’arrêt de travail.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Hommes et
    - Femmes sous contraception oral (pour les femmes en âge de procréer)
    - 18 à 60 ans.
    - Première admission pour l’épisode de colique néphrétique sans signes de complication (apyrétique, sans insuffisance rénale au bilan d’entrée, béta –HCG négatives (femmes en âge de procréer), sans vomissements importants, sans uropathie malformative connue sous-jacente.).
    - En capacité de délivrer son consentement.

    -Calcul :
    Unique
    Prouvé par l’imagerie : Scanner Abdominopelvien hélicoïdal sans injection de contraste– ASP.
    Radio-opaque à l’ASP.
    Plus de 3mm et <11mm (de 4 à 10 mm) de diamètre transversal.
    E.4Principal exclusion criteria
    - Grossesse évolutive ou femme allaitante
    - Absence de contraception orale
    - Contraception par dispositif intra utérin.
    - Infection concomitante (Bandelette urinaire positive pour Nitrites et / ou signes septiques généraux (T°C > 38°5 ou < 36°5 ou frissons.)
    - Insuffisance rénale. (Clairance de la Créatinine calculée selon cockcroft et gault <60 mL/mn).
    - Rein unique fonctionnel.
    - Traitement par inhibiteurs calciques ou alpha bloquants.
    - Chirurgie récente ou prochaine de la cataracte.
    - Hypotension orthostatique.
    - Antécédents d’ulcère gastro-duodénal, d’hépatopathie, d’allergie au paracetamol, au ketoprofène.
    - Antécédents d’AVC, de cardiopathie de diabète.
    - Antécédents d’allergie à l’un des traitements prévus.
    - Refus d’entrer dans le protocole.
    - Déjà inclus dans le protocole.
    - Prise de médicaments contre-indiqués en association avec les AINS (antivitamines K ..)
    - Insuffisance hépatique
    - Participation à une autre recherche biomédicale

    -Calcul :
    Multiples
    Taille <4mm ou >10mm
    Radiotransparent
    Non formellement identifié par imagerie.
    E.5 End points
    E.5.1Primary end point(s)
    Objectif :
    Augmentation du taux d’expulsion spontanée des calculs pelviens de 4 à 10 mm. (Moyenne sans traitement alphabloquant = 50% , Valeur cible = 75%) dans le groupe Silodosine par rapport au groupe de référence.

    Critères d'évalution:
    Expulsion spontanée du calcul pelvien (oui/non).

    L’élimination lithiasique sera prouvée par :
    -un calcul amené par le patient à la consultation et analysé par spectrophotométrie infrarouge (SPIR).
    -si le calcul n’a pas pû être récupéré, une TDM abdominoplevienne sans injection ne retrouvant pas de calcul à J28.


    Un patient sera considéré en échec de traitement si :
    - Présence du calcul sur le scanner de contrôle
    - Nécessité de mettre en place une sonde urétérale à visée thérapeutique
    - Necessité d’extraire chirurgicalement le calcul
    - Ajustement nécessaire du traitement antalgique
    - Patient perdu de vue à J28.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 jours
    E.5.2Secondary end point(s)
    Objectifs secondaires :
    Diminution de la douleur.
    Raccourcissement du délai d’expulsion.
    Diminution de la consommation de soins (hospitalisations, consultations, actes chirurgicaux).
    Diminution du nombres de journées d’arrêt de travail.

    Critères d'évaluation :
    Le délai d’expulsion est défini par le nombre de jours séparant l’inclusion (J1) et l’élimination du calcul, physiquement identifié comme tel par le patient, qui le notera sur une feuille de suivi qui lui a été remise.

    La douleur, définie par l’EVA maximale par jour, recueillie par le patient sur la fiche fournie à l’inclusion. La durée des douleurs avant et après expulsion du calcul sera également observée jusqu'à J28.

    Le nombre de jours d’arrêt de travail sera prouvé par un double de l’imprimé cerfa d’arrêt de travail remis au patient par un médecin.

    Le recours aux soins sera suivi par cette même feuille en y reportant les consultations d’omnipraticien, aux services des urgences.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 jours
    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) Yes
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard seul (antalgiques,antiinflammatoires non stéroïdiens,contrôle des apports hydriques)
    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 concerned2
    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
    dernière visite du dernier patient
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 160
    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 state160
    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 Decision2014-03-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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