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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42572   clinical trials with a EudraCT protocol, of which   7010   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2011-000670-62
    Sponsor's Protocol Code Number:M0001-C401(SPD555-C401)
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-03
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2011-000670-62
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia, la calidad de vida, la seguridad y la tolerabilidad del tratamiento a largo plazo (24 semanas) con prucaloprida en pacientes mayor o igual a 18 años de edad con estreñimiento crónico A randomised, double-blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of long-term treatment (24 weeks) with prucalopride in subjects aged 18 years or more with chronic constipation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Un estudio para evaluar la potencia, calidad de vida, efectos secundarios y
    tolerabilidad del tratamiento a largo plazo (24 semanas) con prucaloprida en
    pacientes con edad ≥ 18 años con estreñimiento crónico.
    A.4.1Sponsor's protocol code numberM0001-C401(SPD555-C401)
    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 SponsorShire-Movetis NV
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportShire-Movetis NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationShire-Movetis NV
    B.5.2Functional name of contact pointShire-Movetis Clinical Trials
    B.5.3 Address:
    B.5.3.1Street AddressVeedijk 58
    B.5.3.2Town/ cityTurnhout
    B.5.3.3Post code2300
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32 14 404 390
    B.5.5Fax number+32 14 404 391
    B.5.6E-mailShire-Movetis.clinicaltrials@shire.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 Resolor 2 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE-MOVETIS NV
    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 nameResolor
    D.3.2Product code M0001
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNPRUCALOPRIDA SUCCINATO
    D.3.9.1CAS number 179474818
    D.3.9.2Current sponsor codeM0001
    D.3.9.3Other descriptive namePRUCALOPRIDA SUCCINATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 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 Resolor 1 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderSHIRE-MOVETIS NV
    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 nameResolor
    D.3.2Product code M0001
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNPRUCALOPRIDA SUCCINATO
    D.3.9.1CAS number 179474818
    D.3.9.2Current sponsor codeM0001
    D.3.9.3Other descriptive namePRUCALOPRIDA SUCCINATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboCoated tablet
    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
    Chronic constipation
    Estreñimiento crónico
    E.1.1.1Medical condition in easily understood language
    Chronic constipation
    Estreñimiento crónico
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10010774
    E.1.2Term Constipation
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia a largo plazo (24 semanas) de prucaloprida frente a placebo en pacientes mayores de 18 años con estreñimiento crónico.
    E.2.2Secondary objectives of the trial
    Evaluar la seguridad, la tolerabilidad y el efecto sobre la calidad de vida a largo plazo de prucaloprida frente a placebo en pacientes mayores de 18 años con estreñimiento crónico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Principales criterios de inclusión que deben evaluarse en la selección:

    1. El paciente es un varón o una mujer que no está embarazada ni amamantando, que recibe tratamiento ambulatorio y tiene mas o 18 años de edad (sin límite de edad máxima).
    2. El paciente presenta antecedentes de estreñimiento. El paciente refiere que tiene un promedio de 2 o menos EIE a la semana que provocan una sensación de evacuación completa (EICE), y una o más de las siguientes características durante al menos 6 meses antes de la visita de selección:
    a) Muy duro (bolas pequeñas) y/o al menos una cuarta parte de las heces son duras;
    b) Sensación de evacuación incompleta después de al menos una cuarta parte de las heces;
    c) Necesidad de realizar un esfuerzo al defecar al menos una cuarta parte del tiempo.
    Los criterios anteriores sólo son aplicables a las EIE, es decir, las EI no precedidas durante las 24 horas anteriores por la ingesta de un laxante o la aplicación de un enema.
    Se considera que los pacientes que no tienen nunca una EIE están estreñidos y son elegibles para el estudio.
    3. El paciente acepta dejar de tomar el tratamiento laxante actual y está dispuesto a utilizar la medicación de rescate de acuerdo con la norma de rescate [bisacodilo (Dulcolax®) y enemas]
    Principales criterios de inclusión deben comprobarse en la aleatorización:
    1. Durante la fase de preinclusión, el paciente refiere que tiene un promedio de 2 o menos EIE a la semana que provocan una sensación de evacuación completa (EICE). 2. El paciente ha interrumpido su tratamiento laxante y no ha usado mediación de rescate durante más del 75% de los días de la fase de preinclusión.
    3. El paciente no ha utilizado medicación no permitida durante la fase de preinclusión
    E.4Principal exclusion criteria
    Principales criterios de exclusión que deben evaluarse en la selección:
    1. Pacientes en los que se considera que el estreñimiento está causado por fármacos.
    2. Pacientes que utilizan cualquier medicamento no permitido
    3. Pacientes que han recibido previamente prucaloprida.
    4. Pacientes que presentan causas secundarias de estreñimiento crónico
    E.5 End points
    E.5.1Primary end point(s)
    El parámetro principal es la proporción (%) de pacientes con un promedio de 3 o más EICE a la semana, evaluado a lo largo de las 24 semanas de la fase de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    El período de evaluación más importantes será el de la fase de tratamiento de 24 semanas doble ciego. Este extremo también será evaluado en períodos de 4
    semanas y por semana de tratamiento.
    E.5.2Secondary end point(s)
    A
    - Proporción de pacientes con un aumento promedio de ≥ 1 EICE a la semana.
    - Número promedio de EI(CE) a la semana y cambio respecto al valor basal.
    - Número de EI(CE) a la semana: estadísticos descriptivos y distribución en categorías como 0, (0;1),[1;2),[2;3),[3;).
    - Consistencia de cada EI(CE): estadísticos descriptivos de una puntuación de 7 grados y % de EI (CE) con una consistencia normal (tipo 3 o 4 en la escala de heces de Bristol) y % de EI(CE) con una consistencia dura o muy dura (tipo 1 o 2 en la escala de heces de Bristol).
    - Esfuerzo en cada EI(CE): estadísticos descriptivos de una puntuación de 5 grados y % de EI(CE) en las que no fue necesario realizar esfuerzo y en las que fue necesario realizar un esfuerzo intenso o muy intenso.
    - Sensación de evacuación completa en cada EI(E): % de EI(E) con sensación de evacuación completa.
    - Tiempo promedio que transcurre hasta la primera EI(CE) tras la primera toma de la medicación del estudio (día 1) y en el día 28 (semana 4).
    - Número promedio de comprimidos de bisacodilo (Dulcolax®) ingeridos a la semana y número de días en que se utilizó bisacodilo (Dulcolax®) a la semana.
    B
    - Evaluación global del paciente respecto a la gravedad del estreñimiento (escalas de 5 grados; 0 = ninguno, 4 = muy grave).
    - Evaluación global del paciente respecto a la eficacia del tratamiento (escalas de 5 grados; 0 = ninguna, 4 = extremadamente eficaz).
    - Evaluación de los síntomas gastrointestinales inferiores del paciente mediante la puntuación total del PAC-SYM, las puntuaciones de las subescalas (síntomas relativos a las heces, síntomas abdominales y síntomas rectales) y las puntuaciones obtenidas en cada elemento (escalas de 5 grados; 0 = ninguno, 4 = muy grave).
    Los datos relativos a la calidad de vida determinados en las visitas programadas serán analizados por visita programada y en el criterio de valoración. En todas las puntuaciones, se proporcionarán estadísticos descriptivos, además de tabulaciones que muestren el porcentaje de pacientes con una mejoría promedio de ≥ 1 grado.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Los parámetros secundarios en la categoría A se derivarán de la e-diario y evaluados durante el período de tratamiento de 24 semanas, así como después de 4 semanas de tratamiento y por semana de tratamiento.
    Los parámetros secundarios de la categoría B se resumen programados por
    visitas y el punto final (la última observación realizada, LOCF), tanto para los valores observados como los cambios desde el inicio.
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    ultima visita del ultimo paciente
    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 months6
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days1
    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: 53
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state73
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 340
    F.4.2.2In the whole clinical trial 340
    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)
    n/a
    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 Decision2011-07-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-19
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA