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    Summary
    EudraCT Number:2014-000779-26
    Sponsor's Protocol Code Number:ECABUSCA12
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-04
    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 number2014-000779-26
    A.3Full title of the trial
    Efficacy of subcutaneous butylscopolamine vs placebo for control to death rattle in agony. Randomized clinical trial.
    Eficacia de la buscapina subcutánea vs placebo en el control de los estertores en agonía. Ensayo clínico aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial to investigate the effect of butylscopolamine as a control of to death rattle in agony
    Ensayo clínico para investigar los efectos de la buscapina como control de los estertores en agonía
    A.3.2Name or abbreviated title of the trial where available
    the ECABUSCA12 trial
    Estudio ECABUSCA12
    A.4.1Sponsor's protocol code numberECABUSCA12
    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 SponsorAsociación Instituto Biodonostia
    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 supportAsociación Instituto Biodonostia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAsociación Instituto Biodonostia
    B.5.2Functional name of contact pointUnidad Ensayo Clínicoº
    B.5.3 Address:
    B.5.3.1Street AddressPº Dr. Beguiristain s/n
    B.5.3.2Town/ citySan Sebastian
    B.5.3.3Post code20014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034943006139
    B.5.5Fax number0034943006250
    B.5.6E-maileecc@biodonostia.org
    D. IMP Identification
    D.IMP: 1
    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.2.1.1.1Trade name BUSCAPINA Compositum ampollas BOEHRINGER INGELHEIM ESPAÑA
    D.2.1.1.2Name of the Marketing Authorisation holderBUSCAPINA Compositum ampollas BOEHRINGER INGELHEIM ESPAÑA
    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 nameBuscapina
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.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.2.1.1.1Trade name Suero Fisiologico Braun 1 ampolla de 10 ml de B. BRAUN MEDICAL, S.A.
    D.2.1.1.2Name of the Marketing Authorisation holderB. BRAUN MEDICAL, S.A.
    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 namesuero fisiologico
    D.3.4Pharmaceutical form Concentrate for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    phase of agony, pre-death
    fase de agonia prefallecimiento
    E.1.1.1Medical condition in easily understood language
    Control of death rattles as a consequencie of agony pre-death
    Control de los estertores como consequencia de agonia prefallecimiento
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    Compare the effectiveness of treatment with hyoscine N-butylbromide (Buscopan) vs placebo in controlling secretions in agony.
    Comparar la eficacia del tratamiento con de N-butilbromuro de hioscina (buscapina) Vs placebo en el control de secreciones en agonía.
    E.2.2Secondary objectives of the trial
    Evaluate the effectiveness of preventive treatment of hyoscine N-butylbromide (Buscopan) to avoid the appearance of death rattles.

    Assess the required dose of hyoscine N-butylbromide (Buscopan) to control of death rattles.

    Evaluate the treatment time is needed to control the rattle.

    To evaluate the presence / absence of urinary retention.

    Number of patients requiring rescue medication due to the agitation.
    Evaluar la eficacia del tratamiento preventivo de la de N-butilbromuro de hioscina (buscapina) para evitar la aparición de estertores.

    Valorar la dosis necesaria de de N-butilbromuro de hioscina (buscapina) para el control de estertores.

    Evaluar el tiempo de tratamiento que se precisa para el control de los estertores.

    Nº pacientes que precisan medicación de rescate debido a la agitación.

    Evaluar la presencia/ausencia de retención urinaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The patient wishes to die at home and your family / carers are able to take care.

    Accept participation in the study (informed consent will be signed by the patient or family depending on the degree of autonomy of the patient).

    Over 18 years of age.

    Diagnosis of malignancy any location terminally ill (prognosis of less than 6 months and life outside of active treatment).
    Que el paciente desee fallecer en domicilio y que su familia/cuidadores sean capaces de asumir el cuidado.

    Aceptar la participación en el estudio (consentimiento informado que será firmado por el paciente o familiar dependiendo del grado de autonomía del paciente).

    Edad superior a 18 años.

    Diagnóstico de neoplasia maligna de cualquier localización en situación terminal (pronóstico de vida menor de 6 meses y fuera de tratamiento activo).
    E.4Principal exclusion criteria
    Patient COPD
    Patient with acute lung edema
    Patient with acute respiratory infection (aspiration)
    In another experimental drug treatment
    Paciente EPOC severo
    Paciente con Edema Agudo de Pulmón
    Paciente con infección respiratoria aguda (aspiración)
    En tratamiento con otro fármaco experimental
    E.5 End points
    E.5.1Primary end point(s)
    The outcome measure will be depend on the degree of death rattles
    La medida del resultado dependerá del grado de los estertores
    E.5.1.1Timepoint(s) of evaluation of this end point
    The death rattles measured on a audible scale
    Los estertores medidos en una escala audible
    E.5.2Secondary end point(s)
    Number of patients who required rescue medication for anxiety / agitation once induced sedation and initiated treatment.

    No. of patients who required increased medication intervention (double dose).

    No patients in the double-blind was broken

    Final Perception opinion of the caregiver
    Nº de pacientes que han precisado medicación de rescate por desasosiego/agitación una vez inducida la sedación e iniciado el tratamiento.

    Nº pacientes que han precisado aumento de la medicación de intervención (doblar la dosis).

    Nº pacientes en los que se rompió el doble ciego

    Percepción final subjetiva del cuidador
    E.5.2.1Timepoint(s) of evaluation of this end point
    for all secondary times points are measured with the audible scale
    para todos los puntos de tiempo se valoran con la escala audible
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLP
    UVUP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 124
    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 state186
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 186
    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. the patient dies
    ninguno, el paciente fallece
    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 Decision2014-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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