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    Summary
    EudraCT Number:2016-001812-39
    Sponsor's Protocol Code Number:TASDA_001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-08-08
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2016-001812-39
    A.3Full title of the trial
    Acute uncomplicated diverticulitis: prospective, controlled, randomized, multicenter clinical trial of non-antibiotic outpatient treatment (TASDA trial).
    Diverticulitis aguda no complicada: ensayo clínico prospectivo, controlado, aleatorizado y multicéntrico de tratamiento ambulatorio sin antibiótico (TASDA trial)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    OUTPATIENT TREATMENT WHITOUT ANTIBIOTIC IN ACUTE UNCOMPLICATED DIVERTICULITIS
    TRATAMIENTO AMBULATORIO SIN ANTIBIÓTICO DE LA DIVERTICULITIS AGUDA NO COMPLICADA
    A.3.2Name or abbreviated title of the trial where available
    TASDA
    TASDA
    A.4.1Sponsor's protocol code numberTASDA_001
    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 SponsorHospital Universitario Vall d'Hebron
    B.1.3.4CountrySpain
    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 supportHospital Universitario Vall d'Hebron
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitario Vall d'Hebron
    B.5.2Functional name of contact pointNuria Ortega
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de Vall d'Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number349327465876587
    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 Amoxicilina/Ac clavulanico
    D.2.1.1.2Name of the Marketing Authorisation holder.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCiprofloxacino
    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 INNAmoxicilina
    D.3.9.1CAS number .
    D.3.9.4EV Substance CodeSUB07470MIG
    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
    Uncomplicated acute diverticulitis
    Diverticulitis aguda no complicada
    E.1.1.1Medical condition in easily understood language
    Uncomplicated acute diverticulitis
    Diverticulitis aguda no complicada
    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
    We want to evaluate the efficacy and safety of outpatient management without antibiotics in the context of uncomplicated acute diverticulitis and comparable according to parameters of relapse and rate of complications published in the studies who treat these patients with antibiotics.
    Evaluar la eficacia y seguridad del manejo ambulatorio sin antibióticos en el contexto de diverticulitis aguda no complicada, y observar si es comparable según parámetros de recidiva y tasa de complicaciones a los datos publicados del tratamiento ambulatorio con antibióticos.
    E.2.2Secondary objectives of the trial
    Secondary variables will be recurrence of acute diverticulitis within the first year after treatment of the study episode (radiological confirmation with new abdominal CT) or mortality due to disease within 12 months after discharge.
    Las variables secundarias serán la recidiva de episodio de diverticulitis aguda dentro del primer año tras el tratamiento del episodio de estudio (confirmación radiológica con nuevo TC abdominal) o mortalidad debida a causa de la enfermedad en los siguientes doce meses después del alta
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients older than 18 years with diagnosis of type Ia diverticulitis (modified Hinchey)

    Patients who sign informed consent
    Pacientes mayores de 18 años con diagnóstico de diverticulitis tipo Ia (Hinchey modificada)

    Pacientes que firmen el consentimiento informado
    E.4Principal exclusion criteria
    Diverticulitis Ib: pericolic abscess, II: pelvic, intra-abdominal or retroperitoneal abscess, III: purulent peritonitis, IV: fecaloid peritonitis.

    Pregnancy or breastfeeding.

    Previous antibiotic treatment in the previous month for another cause.

    Second episode of diverticulitis.

    Suspicion of colon cancer.

    Immunosuppressive status (treatment with corticosteroids, immunosuppressants,

    Drugs, transplanted, renal failure with hemodialysis, immunodeficiencies

    Congenital or acquired.

    Cognitive deficit.

    Refusal to sign informed consent.

    Rejection to protocolized follow-up.

    Violation of assigned treatment.
    Diverticulitis más severa que tipo Ia (Hinchey modificada): Diverticulitis Ib: absceso pericólico, II: absceso pélvico, intrabdominal o retroperitoneal, III: peritonitis purulenta, IV: peritonitis fecaloidea.

    Embarazo o lactancia.

    Tratamiento antibiótico previo en el mes anterior por otra causa.

    Segundo episodio de diverticulitis.

    Sospecha de cáncer de colon.

    Estado de inmunosupresión (tratamiento con corticoides, inmunosupresores,

    drogas, trasplantados, insuficiencia renal con hemodiálisis, inmunodeficiencias

    congénitas o adquiridas.

    Déficit cognitivo.

    Rechazo a firmar el consentimiento informado.

    Rechazo al seguimiento protocolizado.

    Violación del tratamiento asignado.
    E.5 End points
    E.5.1Primary end point(s)
    La principal variable del estudio será evaluar el fallo del tratamiento.
    The main variable of the study will be to evaluate the treatment failure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Las variables secundarias serán la recidiva de episodio de diverticulitis aguda dentro del primer año tras el tratamiento del episodio de estudio (confirmación radiológica con nuevo TC abdominal) o mortalidad debida a causa de la enfermedad en los siguientes doce meses después del alta.
    Secondary variables will be recurrence of acute diverticulitis within of the first year after the treatment of the study episode (radiological confirmation) or mortality due to the disease in the twelve months after discharge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) 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
    Estudio comparativo de tratamiento antibiótico habitual contra no tratamiento
    Comparative treatment with usually antibiotic with no treatment
    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
    Estudio comparativo de tratamiento antibiótico habitual contra no tratamiento
    Comparative treatment with usually antibiotic with no treatment
    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 Yes
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 years3
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 state340
    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)
    There are not differences
    No hay diferencias en el tratamiento ni en el seguimientos una vez acabado el estudio
    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 Decision2017-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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