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    Summary
    EudraCT Number:2012-003620-20
    Sponsor's Protocol Code Number:P101005
    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:2016-02-08
    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 number2012-003620-20
    A.3Full title of the trial
    Tamsulosin to prevent the failures of early bladder catheter removal after acute urinary retention in elderly women hospitalized for an acute medical problem
    Tamsulosine pour prévenir les échecs de retrait de sonde vésicale précoce après rétention aiguë d’urines chez la femme âgée hospitalisée pour un problème médical aigu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tamsulosin to prevent the failures of early bladder catheter removal after acute urinary retention in elderly women hospitalized for an acute medical problem
    A.3.2Name or abbreviated title of the trial where available
    TAMSU
    A.4.1Sponsor's protocol code numberP101005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01747993
    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 SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 supportMinistry of health ( PHRC)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailpauline.cavelier@aphp.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 Tamsulosine Arrow LP 0,4 mg, gélule à libération prolongée
    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.3.1Product nameTamsulosine Arrow LP 0,4 mg, gélule à libération prolongée
    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 INNchlorhydtrate de tamsulosine 0,4
    D.3.9.3Other descriptive nameTAMSULOSINE ARROW LP 0,4 mg gél LP
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,4
    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
    urinary disorder
    trouble fonctionnels urinaires
    E.1.1.1Medical condition in easily understood language
    urinary disorder
    trouble urinaire
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10001055
    E.1.2Term Acute retention of urine
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to evaluate the efficacy of a 6-day treatment with tamsulosin versus placebo in women aged over 75 years hospitalized for acute medical problem and with acute urinary retention
    L'objectif principal est d'évaluer l'efficacité d'un traitement de 6 jours par tamsulosine versus placebo chez les femmes âgées de plus de 75 ans hospitalisées pour un problème médical aigu et souffrant d'une rétention aiguë d'urines.
    E.2.2Secondary objectives of the trial
    1 to show a reduction in the percentage of nosocomial urinary infections under tamsulosin ;
    2- to evaluate the safety of tamsulosin ;
    3- compare the length of hospitalization between the two groups .
    1- de montrer une réduction du pourcentage des infections urinaires nosocomiales sous tamsulosine ;
    2- d'évaluer la tolérance du traitement par tamsulosine ;
    3- de comparer la durée d'hospitalisation entre les deux groupes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Woman hospitalized in internal medicine or geriatrics and acute with acute urine retention (defined as urinary volume collected immediately after the laying of the upper urinary catheter 400 mL) for less than 48 hours ( emergency or in the process of hospitalization)
    - Patient beneficiary of a social security scheme or entitled (except AME )
    - Patient or their legal representative or trusted person who signed the consent
    - Age de 75 ans ou plus,
    - Femme hospitalisée en médecine interne ou gériatrie aiguë et souffrant d'une rétention aiguë d'urines (définie par un volume urinaire recueilli immédiatement après la pose de la sonde vésicale supérieur à 400 ml) depuis moins de 48h (aux urgences ou en cours d'hospitalisation)
    - Patiente bénéficiaire d'un régime de sécurité sociale ou ayant droit (sauf AME)
    - Patiente ou leur représentant légal ou leur personne de confiance ayant signé le consentement

    E.4Principal exclusion criteria
    - Chronic retention of urine,
    - Retention of anatomical causes pelvic tumor, previous pelvic surgery,
    - Retention of neurological causes (spinal, peripheral): peripheral neuropathy, spinal cord compression, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease,
    -Other reason for urinary catheterization (eschar protection, monitoring of urine output)
    - patient in the end-of-life phase
    - Hypersensitivity to tamsulosin hydrochloride, to one of the constituents of the drug or other alpha-blocker,
    History of symptomatic orthostatic hypotension,
    - Severe hepatic failure,
    - Severe renal failure ( creatinine clearance below 10 ml / min according to the Cockcroft )
    - Patient unable to express informed consent ( including dementia with MMS < 20) and without legal representation ,
    - Planned hospitalization duration less than 6 days.
    - Rétention chronique d'urines,
    -Rétention de causes anatomiques : tumeur pelvienne, antécédent de chirurgie pelvienne,
    -Rétention de causes neurologiques (médullaire, périphérique) : neuropathies périphériques, compression médullaire, sclérose en plaques, sclérose latérale amyotrophique, maladie de Parkinson,
    -Autre motif de sondage (protection d'escarre, surveillance de la diurèse),
    -Malade en fin de vie,
    -Hypersensibilité au chlorhydrate de tamsulosine, à l'un des constituants du médicament ou à tout autre alpha-bloquant,
    - Antécédent d'hypotension orthostatique symptomatique,
    -Insuffisance hépatique sévère,
    -Insuffisance rénale sévère (clairance à la créatinine inférieure à 10 ml/min selon la formule de Cockcroft),
    -Patiente hors d'état d'exprimer un consentement éclairé (notamment démence avec MMS < 20) et sans représentant légal,
    -Durée d'hospitalisation prévue inférieure à 6 jours.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the failure rate of urinary catheter withdrawal achieved between J2 (midnight) and J3 (morning) of treatment, requiring a urinary catheter re-installation in the following 72 hours. The failure rates of early bladder catheter withdrawal is estimated at J6.
    Le critère de jugement principal est le taux d'échecs du retrait de sonde vésicale réalisé entre J2 (minuit) et J3 (matin) du traitement, nécessitant de reposer une sonde vésicale dans les 72h suivantes. Le taux d'échecs du retrait de sonde vésicale précoce est évalué à J6.
    On appelle un échec du retrait de sonde vésicale, la récidive du globe urinaire suspectée par la clinique, la radiologie (bladder-scan, échographie) et confirmée par un volume vésical supérieur à 400 ml, selon la quantification du volume recueilli à la repose d'une sonde urinaire.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The failure rates of early bladder catheter withdrawal is estimated at J6 of treatment
    Le taux d'échecs du retrait de sonde vésicale précoce est évalué à J6.
    E.5.2Secondary end point(s)
    1. Percentage of symptomatic and asymptomatic nosocomial urinary infections on a urine collection in case of symptoms and systematic at J6.
    2. Percentage of orthostatic hypotension searched systematically before starting treatment, at D3 and D6, and at any time in case of postural symptoms (dizziness, blurred vision, faintness or syncope).
    3. Number of days of hospitalization in both groups
    1. Pourcentage d’infections urinaires nosocomiales symptomatiques et asymptomatiques sur un recueil urinaire en cas de symptômes et systématique à J6.
    2. Pourcentage d’hypotensions orthostatiques recherchées de façon systématique avant l’instauration du traitement, à J3 et à J6, et à n’importe quel moment en cas de symptôme postural (sensation vertigineuse, trouble visuel, lipothymie ou syncope).
    3. Nombre de jours d’hospitalisation dans les deux groupes
    E.5.2.1Timepoint(s) of evaluation of this end point
    J0, J3, J6,J12
    J0, J3, J6,J12
    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 No
    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 concerned8
    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
    LVLS
    dernière visite du dernier sujet
    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) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 448
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state448
    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
    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 Decision2013-06-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    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
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