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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42517   clinical trials with a EudraCT protocol, of which   7000   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).


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    Summary
    EudraCT Number:2014-000411-14
    Sponsor's Protocol Code Number:6639-SP
    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:2017-12-01
    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 number2014-000411-14
    A.3Full title of the trial
    A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3 Spain).
    Ensayo de no inferioridad, aleatorizado, doble ciego, de una dosis diaria de 600mg, 300mg o 100mg de aspirina con cubierta entérica, como prevención del cáncer en pacientes portadores de un defecto genético germinal en genes reparadores de errores de la replicación, síndrome de Lynch. Proyecto 3 del Programa de Prevención del Cancer (CaPP3 Spain).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CaPP3 Spain
    A.3.2Name or abbreviated title of the trial where available
    CaPP3 Spain
    A.4.1Sponsor's protocol code number6639-SP
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN16261285
    A.5.4Other Identifiers
    Name:EudraCTNumber:2014-000411-14
    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 SponsorNAVARRBIOMED-FUNDACION MIGUEL SERVET
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNavarrabiomed
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportBayer Pharma
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNAVARRABIOMED-FUNDACION MIGUEL SERVET
    B.5.2Functional name of contact pointNAVARRABIOMED-FUNDACION MIGUEL SERV
    B.5.3 Address:
    B.5.3.1Street AddressC/Irunlarrea 3
    B.5.3.2Town/ cityPamplona
    B.5.3.3Post code31008
    B.5.3.4CountrySpain
    B.5.4Telephone number+34848422163
    B.5.5Fax number+34848422200
    B.5.6E-mailinvestigacionclinicafms1@navarra.es
    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 Aspirin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameAspirin
    D.3.4Pharmaceutical form 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 INNACETYLSALICYLIC ACID
    D.3.9.1CAS number AS1
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number100 to 600
    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
    Lynch Syndrome
    Síndrome de Lynch
    E.1.1.1Medical condition in easily understood language
    An inherited disorder that increases the risk of many types of cancer, particularly cancers of the colon (large intestine) and rectum, endometrium and also other cancers.
    Trastorno hereditario que aumenta el riesgo de muchos tipos de cáncer, en particular el cáncer de colon (intestino grueso) y recto, endometrio y también otros cánceres.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051981
    E.1.2Term Lynch syndrome
    E.1.2System Organ Class 100000004850
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine whether the cancer preventive properties of enteric coated aspirin in Lynch syndrome are dose sensitive by comparing overall cumulative Lynch syndrome cancer incidence rates annually from 5 years in people who took 100mg, 300mg or 600mg enteric coated aspirin for at least 2 years.
    Determinar si las propiedades preventivas del cáncer de la aspirina con cubierta entérica en el síndrome de Lynch son sensibles a la dosis al comparar las tasas de incidencia acumuladas de cáncer a los 5 años en personas que tomaron 100 mg, 300 mg o 600 mg de aspirina con cubierta entérica durante al menos 2 años.
    E.2.2Secondary objectives of the trial
    • Compare overall primary colorectal cancers in the three treatment groups.
    • Compare overall primary endometrial cancers in the three treatment groups.
    • Compare overall cancers of all types,in the three treatment groups.
    • Compare the burden of adverse events in three treatment groups.
    • Comparar la totalidad de cánceres colorrectales primarios en los tres grupos de tratamiento.
    • Comparar la totalidad de cánceres endometriales primarios en los tres grupos de tratamiento.
    • Comparar la totalidad de cánceres de cualquier tipo, en los tres grupos de tratamiento.
    • Comparar la cantidad y gravedad de eventos adversos en tres grupos de tratamiento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age over 18.
    2. Confirmed germline pathological variant in one of the mismatch repair genes; MSH2, MLH1, PMS2 or MSH6 or a 3’ EPCAM deletion associated with MSH2 silencing or be a carriers of a constitutional epimutation manifesting a classic Lynch syndrome phenotype.
    3. Able to swallow tablets.
    4. Willing to complete the CaPP3 consent process as described in the patient information sheet.
    1. Edad mayor de 18 años.
    2. Variante patológica confirmada de la línea germinal en uno de los genes reparadores de desemparejamientos; MSH2, MLH1, PMS2 o MSH6 o una deleción 3 'EPCAM asociada con el silenciamiento de MSH2 o ser portadores de una epimutación constitucional que manifiesta un fenotipo de síndrome de Lynch clásico.
    3. Capaz de tragar las tabletas.
    4. Dispuesto a completar el proceso de consentimiento tal como se describe en la hoja de información del paciente.
    E.4Principal exclusion criteria
    1. Regular use of an oral non-steroidal anti-inflammatory agent on long-term basis. Regular is defined as > 3 doses per week, for more than 3 months in the last 3 years.
    2. Previous regular use of aspirin at a daily dose of 150mg or less does not exclude enrolment but duration and quantity need to be documented in detail. More than 3 months use of > 150mg or more per day in the last 3 years is an exclusión.
    3. Known aspirin intolerance or hypersensitivity, including aspirin-sensitive asthma.
    4. Existing clinically significant liver impairment.
    5. Existing renal failure defined as creatinine clearance <10ml/min
    6. Confirmed active peptic ulcer disease within the previous three months.
    7. Known bleeding diathesis or concomitant anticoagulant therapy.
    8. Inability to comply with study procedures and agents.
    9. Women reporting that they are pregnant or actively planning to achieve a pregnancy within the next two years.
    10. Women who are breastfeeding.
    11. Any significant medical illness that would interfere with study participation. (If hypertension is discovered, the participant should be advised to have this treated before commencing trial medication).
    12. Bi-allelic Mismatch Repair Deficiency BMMRD (also known as Constitutional Mismatch Repair Deficiency).
    1. Uso regular de un agente antiinflamatorio no esteroideo oral a largo plazo. Regular se define como > 3 dosis por semana, durante más de 3 meses en los últimos 3 años.
    2. El tratamiento previo con aspirina a una dosis diaria de 150 mg o menos no es criterio de exclusión, pero la duración y la cantidad deben documentarse en detalle. El uso de más de 3 meses de > 150 mg al día en los últimos 3 años es criterio de exclusión.
    3. Intolerancia o hipersensibilidad conocida a la aspirina conocida, incluido el asma sensible a la aspirina.
    4. Existencia de insuficiencia hepática clínicamente significativa.
    5. Existencia de insuficiencia renal definida como aclaramiento de creatinina <10 ml / min
    6. Confirmación de enfermedad de úlcera péptica activa en los últimos tres meses.
    7. Diátesis hemorrágica conocida o terapia anticoagulante concomitante.
    8. Incapacidad para cumplir con los procedimientos y tratamientos del estudio.
    9. Mujeres embarazadas o que planean un embarazo dentro de los siguientes dos años.
    10. Mujeres en periodo de lactancia.
    11. Cualquier enfermedad médica significativa que pueda interferir con la participación en el estudio. (Si se diagnostica hipertensión, se le debe recomendar al participante que reciba tratamiento para ello antes de comenzar el tratamiento del ensayo).
    12. Deficiencia de reparación de desemparejamiento bialélica BMMRD (también conocida como deficiencia de reparación de apareamiento constitucional).
    E.5 End points
    E.5.1Primary end point(s)
    The number of new primary mismatch repair deficient cancers (“Lynch syndrome cancers”) at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    Número de nuevos "cánceres del síndrome de Lynch" a los 5 años en pacientes que reciben tratamiento preventivo durante un mínimo de 2 años.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Five years after last recruit enters trial
    Cinco años después de la inclusión del último paciente
    E.5.2Secondary end point(s)
    • The number of new colorectal cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new endometrial cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new cancers of all types at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • Número de nuevos cánceres colorrectales a los 5 años que se desarrollan en los participantes que permanecen en tratamiento prescrito durante un mínimo de 2 años.
    • Número de nuevos cánceres endometriales a los 5 años que se desarrollan en participantes que permanecen bajo tratamiento prescrito durante un mínimo de 2 años.
    • Número de cánceres nuevos de todos los tipos a los 5 años que se desarrollan en los participantes que permanecen en tratamiento prescrito durante un mínimo de 2 años.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • The number of new colorectal cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new endometrial cancers at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • The number of new cancers of all types at 5 years and beyond which develop in participants who remain on prescribed treatment for a minimum of 2 years.
    • Número de nuevos cánceres colorrectales a los 5 años que se desarrollan en los participantes que permanecen en tratamiento prescrito durante un mínimo de 2 años.
    • Número de nuevos cánceres endometriales a los 5 años que se desarrollan en participantes que permanecen bajo tratamiento prescrito durante un mínimo de 2 años.
    • Número de cánceres nuevos de todos los tipos a los 5 años que se desarrollan en los participantes que permanecen en tratamiento prescrito durante un mínimo de 2 años.
    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 No
    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 No
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    End of study is defined as five years from randomisation of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    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: 50
    F.1.3Elderly (>=65 years) No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1500
    F.4.2.2In the whole clinical trial 2000
    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 is no continued provision for intervention for patients after the 7 year study.
    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 Decision2018-01-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-15
    P. End of Trial
    P.End of Trial StatusOngoing
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