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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2018-002101-65
    Sponsor's Protocol Code Number:PI17/01109
    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:2018-07-17
    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 number2018-002101-65
    A.3Full title of the trial
    Assessment of direct biomarkers of aspirin action to develop a precision chemoprevention therapy of colorectal cancer
    Evaluación de biomarcadores de acción directa del ácido acetilsalicílico para el desarrollo de quimioprevención personalizada en el cáncer colorrectal
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of aspirin for the prevention of colorectal cancer
    Evaluación de la aspirina en la prevención del cáncer colorrectal
    A.4.1Sponsor's protocol code numberPI17/01109
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1214-4083
    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 SponsorÁngel Lanas Arbeloa-Instituto de Investigación Sanitaria Aragón
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto de Investigación Sanitaria Aragón
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressAvda. San Juan Bosco 13, planta 0
    B.5.3.2Town/ cityZaragoza
    B.5.3.3Post code50009
    B.5.3.4CountrySpain
    B.5.4Telephone number0034976716582
    B.5.6E-mailemlopezh@iisaragon.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, S.L.
    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.3.4Pharmaceutical 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 50-78-2
    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.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 Adiro 300 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Hispania, S.L.
    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.3.4Pharmaceutical 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 50-78-2
    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 number300
    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
    Colorectal cancer with a recent confirmed diagnosis (less than 48h)
    Cáncer colorrectal con un diagnóstico confirmado reciente (menos de 48h)
    E.1.1.1Medical condition in easily understood language
    colorectal cancer
    cáncer colorrectal
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to perform a study of acetylsalicylic acid by using a proteomic assay for comparing platelet COX-1 and colorectal cancer mucosal COX-1 and COX-2 after different doses of acetylsalicylic acid
    evaluar, mediante un ensayo proteómico, el efecto directo de dosis diferentes de ácido acetilsalicílico sobre COX-1 y COX-2 en plaquetas, tejido colonice sano y tumoral como biomarcadores de eficiencia clínica
    E.2.2Secondary objectives of the trial
    measurement of PGE2 and p-S6 levels in colorectal cancer mucosa, assessment of indirect biomarkers of acetylsalicylic acid action (serum TXB2, PFA and urinary levels of 11-dehydro-TXB2, (TX-M)), evaluation of systemic biomarkers of inflammatory/tumorigenic COX-2 by assessing urinary levels of major metabolite of PGE2 (PGE-M)
    evaluar el efecto del ácido acetilsalicílico en los niveles de PGE2 y p-S& en la mucosa del cáncer colorrectal, estudiar el efecto sobre biomarcadores indirectos de su acción a nivel sistémico (TXB2, PFA y niveles urinarios de 11-deshidro-TXB2 (TX-M)) y analizar biomarcadores sistémicos de actividad de COX-2 inflamatoria/tumorigénica mediante la evaluación de niveles urinarios del principal metabolito de PGE2 (PGE-M)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age from 18 to 80 years old
    - Recent diagnosis (less than 48h) of colorectal cancer by endoscopy and confirmed by anatomopathological study
    - normal hematologic, biochemical, and coagulation values
    - edad entre 18 y 80 años
    - diagnóstico reciente (menos de 48h) de cáncer colorrectal mediante endoscopia y confirmado por estudio anatomopatológico
    - parámetros hematológicos, bioquímicos y de coagulación normales
    E.4Principal exclusion criteria
    - Allergy to AAS or to any other NSAID.
    - Rectal cancer requiring neoadjuvant treatment wthin the two weeks following the beginning of ASA treatment.
    - Previous use of AAS, NSAIDs, antiplatelet agents, corticosteroids or misoprostol within the 15 days prior to diagnosis and/or anticipation of need for treatment with any of these drugs during the study period.
    History of peptic ulcer disease or active peptic ulcer or any other GI disease that may be considered a contraindication to the use of ASA, without the concomitant use of proton pump inhibitors.
    - Diagnosis of bleeding disorders.
    - Diagnosis of cancer (excluding non-melanoma skin cancer) during the previous 3 years.
    - Conditions supposing serious comorbidity, excluding diabetes, and including respiratory, cardiac, hepatic and renal diseases.
    - Active smoking.
    - Pregnancy or breastfeeding.
    - History of drug or alcohol abuse.
    - Alergia a AAS o a algún otro AINE.
    - Cáncer rectal que requiera tratamiento neoadyuvante en las dos semanas siguientes al inicio del tratamiento con AAS.
    - Uso previo de AAS, AINEs, agentes antiplaquetarios, corticosteroides o misoprostol en los 15 días anteriores al diagnóstico y/o previsión de necesidad de tratamiento con alguno de estos fármacos durante el periodo de estudio.
    - Historia de úlcera péptica o úlcera péptica activa o cualquier otra enfermedad GI que pueda considerarse contraindicación para el uso de AAS, sin el uso concomitante de inhibidores de la bomba de protones.
    - Diagnóstico de trastornos hemorrágicos.
    - Diagnóstico de cáncer (excluyendo cáncer de piel no melanoma) en los 3 años previos.
    - Condiciones que supongan comorbilidad grave, excluyendo diabetes, e incluyendo enfermedades respiratorias, cardiacas, hepáticas y renales.
    - Tabaquismo activo.
    - Situación de embarazo o lactancia.
    - Historia de consumo de drogas o abuso de alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of acetylation level of COX enzymes in platelets and non-neoplastic and neoplastic colonic tissues
    Evaluación del nivel de acetilación de las enzimas COX en plaquetas y tejido colónico sano y tumoral
    E.5.1.1Timepoint(s) of evaluation of this end point
    before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment
    antes del comienzo del tratamiento y tras 3-4 semanas de tratamiento con ácido acetilsalicílico
    E.5.2Secondary end point(s)
    assessment of PGE2 level and S6 protein phosphorylation state in colorectal mucosa depending on AAS dosis and assessment of dosis effect e¡over indirect biomarkers
    Evaluación del nivel de PGE2 y del estado de fosforilación de la proteína S6 en mucosa colorrectal dependiendo de la dosis de AAS y evaluación del efecto de la dosis de AAS sobre biomarcadores indirectos a nivel sistémico
    E.5.2.1Timepoint(s) of evaluation of this end point
    before the beginning of the treatment and 3-4 weeks of acetylsalicylic acid treatment
    antes del comienzo del tratamiento y tras 3-4 semanas de tratamiento con ácido acetilsalicílico
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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 Yes
    E.8.2.3.1Comparator description
    diferentes dosis del mismo producto
    different dosage of the same product
    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 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
    LVLS
    la última visita del último participante del ensayo clínico
    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 months3
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state60
    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 Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-16
    P. End of Trial
    P.End of Trial StatusOngoing
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