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    Summary
    EudraCT Number:2013-004269-15
    Sponsor's Protocol Code Number:D-13-01
    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:2014-03-19
    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 number2013-004269-15
    A.3Full title of the trial
    Aspirin and colorectal cancer prevention. Exploring the platelet hypothesis of its mechanism of action
    Ácido acetil salicílico en la prevención del cáncer colorrectal. Papel de las plaquetas en su mecanismo de acción.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aspirin and colorectal cancer prevention. Exploring the platelet hypothesis of its mechanism of action
    Ácido acetil salicílico en la prevención del cáncer colorrectal. Papel de las plaquetas en su mecanismo de acción.
    A.4.1Sponsor's protocol code numberD-13-01
    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 SponsorInsituto Aragonés de Ciencias de la Salud
    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 supportBayer
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Aragonés de Ciencias de la Salud
    B.5.2Functional name of contact pointEva Lopez Hernández
    B.5.3 Address:
    B.5.3.1Street AddressAvda San Juan Bosco 13, Planta 1ª
    B.5.3.2Town/ cityZaragoza
    B.5.3.3Post code50009
    B.5.3.4CountrySpain
    B.5.4Telephone number34976716582
    B.5.5Fax number34976715554
    B.5.6E-mailemlopezh.iacs@aragon.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 Adiro 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER HISPANIA
    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 nameAdiro 100 mg
    D.3.2Product code B01AC06
    D.3.4Pharmaceutical form 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.3.9.3Other descriptive nameACETYLSALICYLIC ACID
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    We will perform this clinical study to address the hypothesis that low-dose aspirin given once daily is acting primarily by selectively acetylating platelet COX-1 and suppressing its activity throughout the 24-hour dosing interval.
    Con este estudio queremos validar la hipótesis de que la toma diaria de AAS a dosis bajas actúa primariamente mediante la acetilación selectiva de la COX-1 plaquetaria y la supresión de su actividad durante el intervalo de dosis de 24 horas.
    E.1.1.1Medical condition in easily understood language
    Not answered
    Not answered
    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
    To verify whether low-dose aspirin (administered for 1 week to obtain a steady-state acetylation of platelet COX-1) causes virtually complete acetylation of COX-1 in platelets, while no acetylated COX-1 is detected in nucleated cells of the colonictissue 24 hours after dosing
    Verificar si el AAS a dosis bajas (administradas durante 1 semana para obtener un estado estable de acetilación de la COX-1 plaquetaria) causa virtualmente acetilación completa de la COX-1 en las plaquetas, mientras que se detecta COX-1 no acetilada en las células nucleadas de los tejidos cólicos tras 24 horas de haber administrado la última dosis.
    E.2.2Secondary objectives of the trial
    - To assess whether at the time when aspirin (enteric coated) reaches the systemic circulation, COX-1 of both platelets and left and right mucosal colonic tissues will be acetylated but the extent of acetylation will be higher in platelets than in recto-colonic tissues.
    -To study the inhibition of platelet COX-1 activity and platelet function by aspirin administration and to verify whether these effects lead to changes in platelet and plasma proteome
    - To assess the effect of aspirin administration on eicosanoid biosynthesis, S1P levels and protein expression of markers of cell growth and progression, in normal tissues or pathological recto-colonic tissues
    -To assess the effect of aspirin on systemic markers of prostanoid biosynthesis in vivo by measuring in urine samples their enzymatic metabolites
    - Evaluar si en el momento en que el AAS administrado alcanza la circulación sistémica la COX-1 plaquetaria y la COX-1 de las células mucosas de colon izquierdo y derecho se acetilan, siendo mayor dicha acetilación en las plaquetas (debido a la exposición a mayores concentraciones presistémicas de AAS ) que en los tejidos cólicos.
    - Estudiar la inhibición de la actividad de COX-1 plaquetaria y la función plaquetaria tras la administración de AAS y verificar si estos efectos producen cambios en el proteoma plaquetario y plasmático.
    -Evaluar el efecto de la administración de AAS en la biosíntesis de ecosanoides, niveles de SIP y expresión proteica de marcadores de crecimiento celular y progresión, en tejido colorrectal normal y patológico.
    - Evaluar el efecto del AAS en marcadores sistémicos de biosíntesis de prostanoides in vivo mediante la medición de sus metabolitos en muestras de orina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Patients should be ? 18 years and no older than 69
    2.Patients should have an indication for screening colonoscopy (patients > 50 years or personal or familiar history of CCR or adenomas )
    a.First degree relative of patient with CRC.
    b.Personal history of adenomas.
    c.People older than 50 and FOBT positive
    3.Routine hematological and biochemical parameters within the normal range
    1)Hombres y mujeres de edad > 18 años ? 69 años.
    2)Pacientes con indicación de colonoscopia de cribado:
    a.Familiares de primer grado de personas con CCR
    b.Historia personal de adenomas
    c.Mayor de 50 años con SOH positiva
    3)Parámetros hematológicos y bioquímicos dentro de la normalidad.
    E.4Principal exclusion criteria
    1.Allergy to aspirin or other NSAIDs.
    2.Previous use of aspirin, NSAIDS, antiplatelet agents, corticosteroids or misoprostol in the previous 15 days and/or anticipated need for these drugs during the study period.
    3.Peptic ulcer history or any other gastrointestinal disease that could be considered a contraindication for aspirin use without the concomitant use of a proton-pump inhibitor
    4.Subjects with a bleeding disorder
    5.Malignancies, excluding CRC, diagnosed in the previous 5 years
    6.Serious comorbid condition, including pulmonary, cardiac, liver or kidney diseases, cigarette smoking, history of drug or alcohol abuse
    7.Pregnant women or breast feeding
    1)Alergia a AAS o a algún otro AINE
    2)Toma de AAS, AINEs, antiagregantes, corticoides o misoprostol los 15 días previos al comienzo del estudio y/o posible necesidad de dichos fármacos durante el periodo de estudio.
    3)Historia de úlcera péptica u otro trastorno gastrointestinal que contraindique el uso de AAS sin uso concomitante de inhibidor de la bomba de protones
    4)Trastornos de la coagulación o presencia de comorbilidad seria.
    5)enfermedad maligna en los últimos 5 años (a excepción de CCR)
    6)Fumador activo, alcoholismo o drogodependencia.
    7)Embarazo o lactancia
    E.5 End points
    E.5.1Primary end point(s)
    The primary end-point of the study will be the assessment of COX-1 acetylation in platelets versus nucleated cells of the colonic tissue, at 24 h after dosing.
    Con este estudio queremos validar la hipótesis de que la toma diaria de AAS a dosis bajas actúa primariamente mediante la acetilación selectiva de la COX-1 plaquetaria y la supresión de su actividad durante el intervalo de dosis de 24 horas
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the days of the follow up time. For more information check the schedule of events
    Durante los días del período de seguimiento. Para más información consultar el protocolo
    E.5.2Secondary end point(s)
    We hypothesize that the inhibitory effect on extra-platelet sources of COX-1 will be short-lasting, if any, affecting only partially COX-1, and this effect will be completely reversed at 24 hours after dosing
    El efecto inhibidor sobre las fuentes extraplaquetarias de COX-1 será de corta duración, si lo hay, afectando parcialmente a COX-1, y su efecto será completamente revertido a las 24 horas de la última dosis
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the days of the follow up time. For more information check the schedule of events
    Durante los días del período de seguimiento. Para más información consultar el protocolo
    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 Yes
    E.6.11Pharmacogenomic Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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
    Last patient last visit
    Última visita del último paciente reclutado
    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 days37
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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 Decision2014-03-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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