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    The EU Clinical Trials Register currently displays   37205   clinical trials with a EudraCT protocol, of which   6118   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).
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2011-005603-32
    Sponsor's Protocol Code Number:K357
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-30
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2011-005603-32
    A.3Full title of the trial
    Use of acetylsalicylic acid (ASA) for enhanced early detection of colorectal neoplasms
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    early detection of colon cancer
    A.3.2Name or abbreviated title of the trial where available
    K357, ASTER
    A.4.1Sponsor's protocol code numberK357
    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 SponsorGerman Cancer Research Center (DKFZ)
    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 supportDKTK
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGerman Cancer Research Center
    B.5.2Functional name of contact pointGerman Cancer Research Center
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 280
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.4Telephone number+496221421349
    B.5.5Fax number+496221421302
    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. name ASS-ratiopharm
    D. of the Marketing Authorisation holderRatiopharm GmbH
    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.3.4Pharmaceutical 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.3.9.1CAS number 50-78-2
    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 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 placeboTablet
    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
    Early detection of Colorectal neoplasms
    E.1.1.1Medical condition in easily understood language
    Early detection of colon cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level HLT
    E.1.2Classification code 10010023
    E.1.2Term Colorectal neoplasms malignant
    E.1.2System Organ Class 100000004864
    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 diagnostic performance (sensitivity, specificity, positive and negative predictive values, likelihood ratios, area under the curve) of 2 immunochemical Fecal Occult Blood Tests (iFOBTs) for detecting advanced colorectal neoplasms after a single dose of acetylsalicylic acid as compared to placebo
    E.2.2Secondary objectives of the trial
    To study gender-specific performance of the 2 iFOBTs and the possible gain in diagnostic performance by stool sampling on multiple days.
    To study the safety of single-dose acetylsalicylic acid in the selected population.
    To collect blood samples for additional biomarker analyses (optional)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age 40 to 80 years (both males and females; premenopausal women must have a negative pregnancy test before inclusion into the study, postmenopausal women are women who have not had menstrual bleeding for at least 12 months, or have been surgically sterilized)
    •Planned screening or diagnostic colonoscopy
    •Able to speak and understand German sufficiently to be able to give written informed consent and comply with the study requirements
    E.4Principal exclusion criteria
    Factors potentially influencing the primary endpoint
    -Chronic inflammatory bowel disease (e.g. Crohn’s disease, colitis ulcerosa)
    -Colonoscopy due to positive fecal occult blood test
    -History of Colorectal cancer
    -Angiodysplasia of the colon
    -Anamnestic or observed blood loss per anum
    Use of any of the following drugs Within 2 weeks before the study:
    -Anticoagulants (including, but not limited to heparin, vitamin K antagonists [e.g. phenprocoumon, warfarin], direct thrombin inhibitors [e.g. dabigatran], or factor Xa inhibitors [apixapan, rivaroxaban])
    -Antiplatelet drugs (e.g. clopidogrel, prasugrel, ticlopidin)
    Within 1 week before the study
    -Acetylsalicylic acid Within 3 days before the study
    -NSAIDs and COX-2 inhibitors
    -Factors potentially affecting the safety
    -Any current clinically relevant signs and symptoms, including
    -Signs and symptoms suggesting acute gastrointestinal ulcer
    -Known clinically relevant thrombocytopenia
    .Acute infection
    -Volume deficit (exsiccosis)
    -Any currently present allergy with dermal reactions, pruritus, or urticaria
    -Severe or insufficiently controlled asthma
    -Severe kidney or liver diseases (e.g. GFR <30 ml/min, liver cirrhosis)
    -Severe, not sufficiently treated heart failure (as judged by the investigator)
    -Severe, poorly controlled arterial hypertension
    -Any other unclear symptoms needing further investigation in the opinion of the investigator
    Any of the following anamnestic findings
    -History of severe gastrointestinal bleeding
    -Known hemorrhagic diathesis, including, but not limited to, hypoprothrombinaemia, severe thrombocytopenia, hemophilia
    -Asthma, except for patients who have used acetylsalicylic acid in the past without negative effects
    -Hypersensitivity against salicylic acid or other ingredients of the study drugs
    -Previous intolerance to NSAIDs, COX-2 inhibitors, or antirheumatic medication
    -Severe gout (e.g. recurrent attacks)
    -Hereditary oxaluria
    -Known G6PD or glutathione peroxidase deficiency
    -Known epilepsy with generalised seizures
    -Severe cardiac diseases (including, but not limited to, myocardial infarction in the past 6 months)
    Intention to use any of the following drugs during the study:
    -Antiplatelet drugs
    -NSAIDs, COX-2 inhibitors
    -Methotrexate ≥ 15 mg/week
    -Systemic glucocorticoids
    -Selective serotonin reuptake inhibitors (SSRIs)
    -valproic acid
    Planned surgery/dental treatment during participation in the study
    Other factors
    Known or suspected relevant alcohol abuse
    Known or suspected illicit drug abuse
    Suspected non-compliance with the study procedures
    Participation in another clinical study
    E.5 End points
    E.5.1Primary end point(s)
    Sensitivity at predefined cutpoints of test positivity of the RIDASCREEN® test to detect advanced neoplasms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    on day 3,4,5
    E.5.2Secondary end point(s)
    • positive and negative predictive values
    • specificity and the area under the curve in ROC analyses
    • likelihood ratios
    • gender-specific performance of the tests
    • gain in diagnostic performance by test application on multiple days
    • serious adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    on day 3,4,5
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    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. 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 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 concerned17
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    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: 2400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2400
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-05-30. Yes
    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 state2400
    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)
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-27
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