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    The EU Clinical Trials Register currently displays   41235   clinical trials with a EudraCT protocol, of which   6758   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2011-003743-22
    Sponsor's Protocol Code Number:D9422C00001
    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:2012-03-08
    Trial results View 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 number2011-003743-22
    A.3Full title of the trial
    A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
    Studio non comparativo, multicentrico, in aperto che ha lo scopo di valutare la sicurezza di Entocort™ EC nel trattamento del morbo di Crohn nei soggetti pediatrici di eta' tra i 5 e 17 anni compresi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Multicenter, Open label, Non-Comparative Study to Evaluate the Safety of Entocort EC for the Treatment of Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive
    Studio non comparativo, multicentrico, in aperto che ha lo scopo di valutare la sicurezza di Entocort™ EC nel trattamento del morbo di Crohn nei soggetti pediatrici di eta' tra i 5 e 17 anni compresi
    A.4.1Sponsor's protocol code numberD9422C00001
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASTRAZENECA
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Clinical Study Information
    B.5.2Functional name of contact pointAstraZeneca Clinical Study Informat
    B.5.3 Address:
    B.5.3.1Street AddressAstraZeneca Clinical Study Information
    B.5.3.2Town/ cityAstraZeneca Clinical Study Information
    B.5.3.3Post code00000
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 236-9933
    B.5.5Fax number001 800 236-9933
    B.5.6E-mailinformation.center@astrazeneca.com
    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 Entocort
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Capsule, hard
    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 INNBUDESONIDE
    D.3.9.1CAS number 51333-22-3
    D.3.9.4EV Substance CodeSUB05955MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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
    Crohn's Disease
    Morbo di Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Morbo di Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to investigate the safety of Entocort (budesonide) in a Paediatric
    population treated for mild to moderate Crohn's disease
    Valutare la sicurezza di Entocort™ EC (budesonide) in una popolazione pediatrica trattata per il morbo di Crohn in forma lieve o moderata
    E.2.2Secondary objectives of the trial
    To characterize the disease activity in the trial population before and
    after treatment through the paediatric Crohn's Disease Activity Index
    (PCDAI); Patient reported outcomes: Quality of Life with Entocort EC
    treatment based on a subject questionnaire (IMPACT 3)
    - Caratterizzare l’attività della malattia nella popolazione in studio attraverso l’indice pediatrico di attività del morbo di Crohn (PCDAI).
    - Valutare la qualità di vita attraverso un questionario compilato dai pazienti (IMPACT 3).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.All male and female subjects must be aged 5 to 17, inclusive, and must
    not have reached their 18th birthday by the estimated final office visit
    2.Subject must be diagnosed with active Crohn's disease of the ileum
    and/or ascending colon confirmed by endoscopic and/or radiographic
    evidence, and/or evidence of mucosal erosions and/or histology within
    the last year
    3.Subjects with mild to moderate Crohn's disease
    4.All subjects must have a stool analysis negative for Clostridium
    difficile, Yersinia enterolytica, Campylobacter jejuni, Salmonella,
    Shigella, within the 30 days prior to visit 1
    5.Alls subjects must have had laboratory assessments within 7 days
    prior to visit 1
    1 Tutti i soggetti di sesso maschile e femminile devono avere età compresa o uguale tra 5 e 17 anni e non dovranno avere compiuto il loro 18 ° compleanno entro la data in cui è prevista la visita finale.
    2 Diagnosi del morbo di Crohn dell’ileo e/o del colon ascendente in fase attiva confermata da prove endoscopiche e / o esami radiografici, e/o evidenza di erosioni della mucosa e/o istologia effettuata nel corso dell'ultimo anno.
    3 Soggetti affetti dal morbo di Crohn in forma lieve o moderata, che necessiterebbero di un trattamento con Entocort ™ CE (ad esempio, in linea con l'indicazione per il trattamento della malattia di Crohn in forma lieve o moderata dell’ ileo e/o del colon ascendente negli adulti).
    4 Analisi negative, per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1.
    5 Ottenimento delle valutazioni di laboratorio entro 7 giorni prima della Visita 1.
    E.4Principal exclusion criteria
    1.Subjects who have had any previous intestinal resection proximal to
    and including the ascending colon
    2.Subjects with evidence of severe active Crohn's Disease and/or,
    structuring and prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications
    3.Subjects who do not have a negative stool analysis, within the 30 days
    prior to Visit 1
    4.Subjects who have been screened/or enrolled in this study previously
    within the last 6 months
    1.Soggetti che hanno avuto una precedente resezione intestinale prossimale compreso il colon ascendente.
    2.Soggetti con evidenza del morbo di Crohn severo attivo e / o, dilatazione stenosante e prestenotica o evidenza clinica di ostruzione, ascessi perirettali, malattia perirettale con fistole drenanti attive, perforazione, o complicanze settiche.
    3.Soggetti che non presentano analisi negativa delle feci per Clostridium difficile, enterolytica Yersinia, Campylobacter jejuni, Salmonella, Shigella, entro i 30 giorni prima della Visita 1.
    4.Soggetti che sono stati precedentemente screenati o arruolati in questo studio negli ultimi 6 mesi.
    E.5 End points
    E.5.1Primary end point(s)
    Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed
    and summarized descriptively, with summaries including all subjects
    who received at least one dose of study treatment. Summaries will be
    produced by all patients and by dose group (6 mg or 9 mg).
    Safety measures such as adverse events, GCS-related side effects, HPAaxis measurement, laboratory test results and vital signs will be listed
    and summarized descriptively, with summaries including all subjects
    who received at least one dose of study treatment. Summaries will be
    produced by all patients and by dose group (6 mg or 9 mg).
    E.5.1.1Timepoint(s) of evaluation of this end point
    end of 8 week treatment period
    al termine delle 8 settimane di trattamento
    E.5.2Secondary end point(s)
    NA
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    NA
    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 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.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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    United States
    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
    LVLS
    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 months22
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months26
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 12
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 6
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) No
    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 No
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 110
    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 Decision2011-12-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-24
    P. End of Trial
    P.End of Trial StatusOngoing
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