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    Summary
    EudraCT Number:2011-003122-27
    Sponsor's Protocol Code Number:767/11
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-003122-27
    A.3Full title of the trial
    Assessment of aspirin response in patients with Type 1 diabetes mellitus: a pilot study
    Valutazione della risposta all`™aspirina in pazienti con Diabete Mellito di tipo 1: studio pilota.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Assessment of aspirin response in patients with Type 1 diabetes mellitus: a pilot study
    Valutazione della risposta all’aspirina in pazienti con Diabete Mellito di tipo 1: studio pilota.
    A.4.1Sponsor's protocol code number767/11
    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 SponsorPOLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
    B.1.3.4CountryItaly
    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 supportNESSUN FINANZIAMENTO
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPOLICLINICO GEMELLI
    B.5.2Functional name of contact pointSERVIZIO DI DIABETOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressL.go Gemelli 8
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630154217
    B.5.5Fax number063050052
    B.5.6E-maildario.pitocco@rm.unicatt.it
    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 CARDIOASPIRIN*30CPR GAST 100MG
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Gastro-resistant 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.3.9.4EV Substance CodeNA
    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
    type 1 diabetes
    diabete di tipo 1
    E.1.1.1Medical condition in easily understood language
    type 1 diabetes
    diabete di tipo 1
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045228
    E.1.2Term Type I diabetes mellitus
    E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assess whether, in patients with type 1 diabetes, changes in the rate of recovery of platelet COX-1 during and after treatment with aspirin at low doses, given at a dose of 100 mg (Cardioaspirin) as a single daily administration, are influenced by the variability of blood glucose in 24 hours.
    Valutare se, nei pazienti diabetici di tipo 1, le variazioni della velocita' di recupero dell’attivita' COX-1 piastrinica durante e dopo il trattamento con aspirina a basse dosi, data al dosaggio di 100 mg (Cardioaspirin) in singola somministrazione giornaliera, siano influenzate dalla variabilita' della glicemia nelle 24h.
    E.2.2Secondary objectives of the trial
    Relationship between glycemic variability and platelet activation
    Relazione tra variabilita' glicemica e attivazione piastrinica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Forty subjects with type 1 diabetes mellitus (30 treated and 10 untreated), male and female, 18-40 years old, BMI: 18-25 Kg/m2 .
    •Diabete mellito di tipo 1; Eta': 18-40 anni; BMI: 18-25 Kg/m2
    E.4Principal exclusion criteria
    -Cigarette smoking; - Allergy or intolerance to aspirin; - Other antiplatelet or anticoagulant treatment; - Presence of congenital bleeding coagulopathy; - Presence of macro/microangiopathy; - Any other known clinical comorbidity (eg celiac disease, hypothyroidism, hepatitis); -Pregnancy or breast feeding; - Any medication, except insulin; -Patients requiring regular use of nonsteroidal antiinflammatory drugs; -Hypertension; -Dyslipidemia; -Type 2 diabetes mellitus.
    • Trattamento anticoagulante in atto o antipiastrinico diverso da aspirina • Presenza di coagulopatia emorragica congenita gia' accertata • Necessita' di assunzione cronica di farmaci antinfiammatori non steroidei (FANS) • Qualsiasi trattamento farmacologico, ad eccezione di insulina • Ipertensione • Dislipidemia • Allergia o intolleranza accertata all’aspirina • Recente evento emorragico • Tabagismo • Gravidanza • Qualsiasi altra comorbidita' clinicamente nota (es. celiachia, ipotiroidismo, epatiti) • Macroangiopatia clinicamente accertata • Microangiopatia clinicamente accertata • Diabete mellito di tipo 2
    E.5 End points
    E.5.1Primary end point(s)
    kinetics of recovery of serum TxB2 formation in the range between 12h and 7 days after the last dose of aspirin (Cardioaspirin,100 mg).
    cinetica di recupero del TXB2 sierico nell`intervallo tra 12h e 7 giorni dopo l`ultima somministrazione di aspirina. La cinetica di risposta dell’aspirina nelle prime 24h, corrispondente all’intervallo tra la somministrazione del farmaco, verra' valutata come differenza in valore assoluto (ng/ml) di TXB2 sierico tra la misura a 12 e 24 ore. Inoltre, le misure giornaliere effettuate tra 24h e 7 giorni dopo sospensione del farmaco, serviranno a valutare la velocita' di recupero totale dell’inibizione della COX-1 piastrinico-megacariocitaria da parte dell’aspirina e la velocita' di ritorno a baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    18 days
    18 giorni
    E.5.2Secondary end point(s)
    correlation between kinetics of recovery of TxB2 formation in 24 h, blood glucose variability (using different indices) and average blood glucose, and platelet morphological indices in the routine blood count.
    correlazione tra cinetica di recupero del TXB2 nelle 24h, variabilita' glicemica (utilizzo di diversi indici) e media glicemica, e indici morfologici piastrinici in emocromo di routine.
    E.5.2.1Timepoint(s) of evaluation of this end point
    18 days
    18 giorni
    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 No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    assenza di farmaco
    the absence of drug
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    the study is completed after the conclusion of the laboratory procedures.
    lo studio termina con la conclusione delle procedure laboratoristiche.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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) 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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 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)
    na
    na
    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 Decision2011-11-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-05
    P. End of Trial
    P.End of Trial StatusOngoing
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