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   43873   clinical trials with a EudraCT protocol, of which   7293   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:2012-005198-30
    Sponsor's Protocol Code Number:BBHV.02-2012
    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:2013-02-04
    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 number2012-005198-30
    A.3Full title of the trial
    EFFICACY OF ADMINISTRATION OF HYOSCINE BUTILBROMIDE (BUSCOPAN®) ON PREGNANT WOMEN IN FIRST STAGE OF LABOUR IN CASE OF CERVIX RIGIDITY.
    (BBH V.04-2013 EUDRACT: 2012-005198-30)
    EFICACIA DE LA ADMINISTRACIÓN DE BUTILBROMURO DE HIOSCINA (BUSCAPINA®) EN MUJERES GESTANTES DURANTE LA FASE DE DILATACIÓN DEL PARTO EN PRESENCIA DE RIGIDEZ CERVICAL.
    (BBH V.04-2013 EUDRACT: 2012-005198-30)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF BUSCOPAN AS AN EASIER OF FIRST STAGE OF LABOUR IF CERVIX RIGIDITY IS PREVIOUSLY DETERMINED BY VAGINAL EXPLORATION
    ADMINISTRACIÓN DE BUSCAPINA COMO FACILITADOR DE LA FASE DE
    DILATACIÓN DEL PARTO EN GESTANTES A TÉRMINO CON CÉRVIX RÍGIDO.
    A.3.2Name or abbreviated title of the trial where available
    BUSCOPAN USE IN CERVIX RIGIDITY IN LABOUR
    A.4.1Sponsor's protocol code numberBBHV.02-2012
    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 SponsorLAURA TARRATS VELASCO
    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 supportLAURA TARRATS VELASCO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLAURA TARRATS VELASCO
    B.5.2Functional name of contact pointLAURA TARRATS VELASCO
    B.5.3 Address:
    B.5.3.1Street AddressC/JOAQUIM RUYRA 1-3, 5º-3ª
    B.5.3.2Town/ cityBADALONA
    B.5.3.3Post code08918
    B.5.3.4CountrySpain
    B.5.4Telephone number0034935395490
    B.5.5Fax number0034934978974
    B.5.6E-maill_tarrats@hotmail.com
    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 BUSCOPAN
    D.2.1.1.2Name of the Marketing Authorisation holderBOERINGER INGELHEIM LIMITED
    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 nameBUSCOPAN
    D.3.2Product code 0104-752
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHYOSCINE BUTYLBROMIDE
    D.3.9.1CAS number 149-64-4
    D.3.9.3Other descriptive nameHYOSCINE BUTYLBROMIDE
    D.3.9.4EV Substance CodeSUB14154MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 1
    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 infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    in case of cervix rigidity determination in first stage of labour, pregnant women will be offered to participate and if they accept they´ll be randomised to test or control group. Placebo or treatment will be administrated in 10 min. and the first control for all of them will be 60minutes later. Rest of controls and cares will be as usual in labour process.
    Durante el trabajo de parto, se realizarán los tactos vaginales protocolizados. En caso de detectar rigidez cervical en uno de ellos, se procederá a confirmar el diagnóstico mediante doble tacto y valorar los criterios de inclusión y exclusión. Se informará a la gestante de la detección de cérvix rígido y se solicitará su participación en el ensayo y firma del consentimiento informado, facilitado previamente.
    E.1.1.1Medical condition in easily understood language
    It is mandatory that pregnant women in first stage of labour are informed that they have a rigid cervix in order to participate in the trial .
    Es imprescindible que las mujeres gestantes en trabajo de parto sean
    informadas de que presentan cervix rígido para poder ofrecerles la
    opción de participar en el ensayo.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To evaluate effectivity of Buscopan intravenous administration as an easier of cervical conditions in first stage of labour in pregnant women assisted in Hospital Universitari Germans Trias i Pujol from Badalona in 2012-2013
    Evaluar la efectividad de la administración de buscapina endovenosa en la mejora de las condiciones cervicales durante la fase de dilatación del trabajo de parto en las gestantes atendidas en el Hospital Universitario Germans Trias i Pujol de Badalona durante el año 2012-13
    E.2.2Secondary objectives of the trial
    -To know if there are any differences in :
    -first stage of labour duration.
    -Neonatal results.
    -cervical conditions
    -fetus heartbeat rate pre-post administration.
    - Conocer si existen diferencias en la duración de la dilatación y en los resultados perinatales según se administre o no tratamiento de buscapina.
    - Conocer si existen diferencias en las condiciones cervicales de las gestantes según se administre o no tratamiento de buscapina.
    -Conocer si existen alteraciones en la frecuencias cardíacas fetal durante la administración de buscapina y post-administración.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Detection, by means of vaginal exploration, of cervical rigidity in first stage of labour
    -18-40 year-old-pregnants
    -cephalic position of fetus
    -Term pregnancy
    - Detección, mediante tacto vaginal, de cérvix rígido en trabajo de parto instaurado
    - Edad entre 18-40 años.
    - Presentación cefálica.
    - Gestación a término (37-42 semanas de gestación (SG)).
    E.4Principal exclusion criteria
    -Non-treated glaucoma.
    -Taquicardia, miastenia gravis, paralitic ilium, mecanical estenose of
    guts, megacolon, allergy or hipersensitivity to Buscopan.
    -Treatment with: triciclic antidepressives, antihistamine drugs,
    quinidina, amantadina, disopiramida, domapine antagonists, betaadrenergics
    and others sucha as digoxine due to possible drug
    interaction.
    -previous cervical surgery
    -Less than 30 min since last peridural anesthetics dose.
    - Gestante con glaucoma de ángulo estrecho no tratado
    - Gestante con taquicardia, miastenia grave, íleo paralítico, estenosis
    mecánica del tracto intestinal, megacolon, alergia o hipersensibilidad a
    buscapina.
    - Gestante que haya mostrado con anterioridad hipersensibilidad al
    principio activo o a cualquier otro componente del preparado.
    -Gestante a la que se administre o que esté en tratamiento con:
    antidepresivos tricíclicos, antihistamínicos, quinidina, amantadina y
    disopiramida, antagonistas dopaminérgicos como la metoclopramida,
    beta-adrenérgicos y otros fármacos como la digoxina por sus posibles
    interacciones farmacológicas.
    -Cirugía cervical previa.
    -Si portadora de catéter peridural: administración de dosis de anestesia
    simultánea o inferior a un intervalo de 30 minutos respecto a la
    administración de buscapina.
    E.5 End points
    E.5.1Primary end point(s)
    -Administration or not administratin of Buscopan 40mg intravenous in
    first stage of labour.
    -Administración o no administración de 40mg de buscapina endovenosa durante la fase de dilatación. Frecuencia: 1 única administración de
    fármaco o placebo en el momento en que la rigidez cervical sea
    determinada.
    E.5.1.1Timepoint(s) of evaluation of this end point
    -when rigid cervix is determined
    -En el momento en que se determine la presencia de cervix rígido.
    E.5.2Secondary end point(s)
    maternal age, race, dilatation number, pregnancy weeks, ovular
    membranes state, Hodge valoration, cervical conditions, use of
    occitocine, cervix estimulation, fetal heart rate, Apgar test evaluation,
    newborn weight.

    edad materna, raza, nº de dilatación, semanas gestación, estado
    membranas ovulares, grado de encajamiento cefalo-pélvico, condiciones
    cervicales, uso de oxitócicos, estimulación del cervix, frecuencia
    cardíaca fetal, valoración test apgar, peso neonato
    E.5.2.1Timepoint(s) of evaluation of this end point
    -ovular membranes state,Hodege valoration and cervical conditions at
    every cervical valoration.
    -Cervix estimulation: once, just considering if cervix has been
    estimulated or not.
    -use of oxitocine: used in intravenous continuous perfusion. used or not
    used.
    -fetal heart rate: pre, meanwhile and post-administration of drug or
    placebo.
    -Newborn Apgar test: 1 minute, 5 minutes and 10 minutes post-birth
    -Newborn weight: once in delivery ward.
    -Estado membranas: estado de las membranas en cada valoración
    cervical.
    -Grado de encajamiento cefalo-pélvico: grado de encajamiento cefalopélvico
    en cada exploración vaginal.
    -Condiciones cervicales: condiciones cervicales en cada exploración
    vaginal.
    -Uso de oxitócicos: mediante bomba de perfusión continua y su
    dosificación se ajusta a la dinámica uterina de forma continuada.
    -Estimulación del cérvix: Se valorará una sola vez
    Frecuencia cardíaca fetal: pre-administración, durante administración, y
    10 minutos post-administración .
    -Test de apgar: minuto de vida, a los cinco y a los 10 minutos . Se
    considerarán los valores obtenidos entre 7 y 10 como indicadores de
    buena adaptación a la vida extrauterina.
    -Peso del recién nacido: Se pesará al neonato 1 vez en sala de partos
    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 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) 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 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 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
    The trial will end when 82 women in first stage of labour with cervix rigidity have been recruted with complete data collection. Sample corrections will be done in case statisthics analyse showed that groups are no homogeneous.
    El ensayo finalizará cuando se hayan recogido correctamente los datos de 82 mujeres (41 por grupo) diagnosticadas de cervix rígido durante la dilatación. Se corregirá el tamaño muestral en caso que el análisis estadístico posterior revele que no los grupos no son homogeneos.
    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 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) Yes
    F.1.2.1Number of subjects for this age range: 82
    F.1.3Elderly (>=65 years) No
    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 No
    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 No
    F.3.3.3Pregnant women Yes
    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 state82
    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
    ninguno
    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 Decision2013-04-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-11
    P. End of Trial
    P.End of Trial StatusOngoing
    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-Tue May 07 12:19:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA