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    Summary
    EudraCT Number:2012-000531-88
    Sponsor's Protocol Code Number:FID-EC-0001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-07-25
    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 number2012-000531-88
    A.3Full title of the trial
    A phase IIIb/IV randomized, controlled, double-blind, double- dummy, parallel group study to compare the efficacy of fidaxomicin to vancomycin in the sustained clinical cure of Clostridium difficile Infection in adults receiving immunosuppressive therapy.
    Studio di fase IIIb/IV randomizzato, controllato, in doppio cieco, double dummy, a gruppi paralleli per confrontare l'efficacia di fidaxomicina vs. vancomicina nella guarigione clinica prolungata da infezioni da Clostridium difficile negli adulti sottoposti a terapia immunosoppressiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This clinical study investigates the effect of fidaxomicin in comparison to vancomycin in adult patients with an infection of Clostridium difficile, and are using medicinal products that suppress the immune system.
    Questo studio clinico vuole indagare l'effetto della fidaxomicina rispetto alla vancomicina in pazienti adulti con ifeione da Clostridium difficile, e che stanno assumendo farmaci per sopprimere il sistema immunitario.
    A.3.2Name or abbreviated title of the trial where available
    FREEDOM study
    Studio Freedom
    A.4.1Sponsor's protocol code numberFID-EC-0001
    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 SponsorASTELLAS PHARMA
    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 supportASTELLAS PHARMA EUROPE LTD.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstellas Pharma Europe Ltd.
    B.5.2Functional name of contact pointGemma Waygood
    B.5.3 Address:
    B.5.3.1Street AddressLovett House, Lovett Road
    B.5.3.2Town/ cityStaines, Middlesex
    B.5.3.3Post codeTW183AZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441784415512
    B.5.6E-mailgemma.waygood@astellas.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 Dificlir
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 INNfidaxomicin
    D.3.9.1CAS number 873857-62-6
    D.3.9.2Current sponsor codeOPT-80
    D.3.9.4EV Substance CodeSUB31455
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RoleComparator
    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 Vancocin
    D.2.1.1.2Name of the Marketing Authorisation holderFlynn Pharma Ltd
    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 INNVANCOMYCIN
    D.3.9.1CAS number 1404-90-6
    D.3.9.4EV Substance CodeSUB05076MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mEq/µl milliequivalent(s)/microlitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    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
    Adult patients with Clostridium difficile infection who are receiving
    immunosuppressive therapy.
    Pazienti adulti con infesione da Clostridium difficile sottoposti a terapia immunosoppressiva
    E.1.1.1Medical condition in easily understood language
    Adult patients with an infection of Clostridium difficile who are using
    medicinal products that suppress the immune system.
    Pazienti adulti con infezione da Clostridium difficile che stanno usando farmaci per sopprimere il sistema immunitario
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10061043
    E.1.2Term Clostridial infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to demonstrate superiority of
    fidaxomicin versus vancomycin for the sustained clinical cure of
    Clostridium difficile Infection (CDI) in adult patients receiving
    immunosuppressive therapy. Sustained clinical cure is defined as clinical
    cure without recurrence within 14 days from Test of Cure (TOC).
    L’obiettivo primario è quello di dimostrare la superiorità di fidaxomicina vs. vancomicina per la guarigione clinica prolungata dalle infezioni da Clostridium difficile (CDI) negli adulti sottoposti a terapia immunosoppressiva. La guarigione clinica prolungata è definita come cure cliniche senza ricomparsa entro 14 giorni dalla valutazione della guarigione clinica (TOC)
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study are
    - to compare the rates of clinical cure of CDI at TOC on Day 12 and of sustained clinical cure of CDI at Day 40 after treatment with fidaxomicin or vancomycin
    -to compare the recurrence rate of CDI after treatment with fidaxomicin or vancomycin
    - to compare the time to resolution of diarrhea on treatment with fidaxomicin or vancomycin
    Gli obiettivi secondari di questo studio sono:
    -confrontare i tassi di guarigione clinica della CDI al TOC al Giorno 12 e di guarigione clinica prolungata della CDI al TOC al Giorno 40 in seguito a trattamento con fidaxomicina o vancomicina
    -confrontare il tasso di recidiva della CDI in seguito a trattamento con fidaxomicina o vancomicina
    -confrontare il tempo alla risoluzione della diarrea in concomitanza con il trattamento con fidaxomicina o vancomicina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject is 18 years of age or over.
    2.CDI is confirmed by clinical symptoms (see Section 5.2.3) and rapid CDI test. (see Section 5.7)
    3.Subject has not been treated with medication or other therapy for CDI within the last 10 days.
    4.Subject is:
    -receiving immunosuppressive therapy
    (chemotherapy) or is undergoing a stem cell transplant procedure (defined as the time period from the start of conditioning prior to transplant
    until 6 months after infusion of stem cells) for a hematological malignancy; or
    -receiving immunosuppressive therapy
    (chemotherapy) for a solid tumor malignancy or following solid organ transplantation; or
    -being treated with immunosuppressive and /or anti-TNF therapy for an auto-immune disease
    5.Subject has signed written informed consent.
    6.Any woman of childbearing potential requires negative serum or urine pregnancy test before entry to the study.
    7.Male and female subjects that are sexually active must agree to practice effective birth control during the study and for 30 days after the end of the study. (An effective method of birth control is defined as those which result in a low failure rate (CPMP/ICH/286/95 modified) of less than 1% per year whenused consistently and correctly such as implants,injectables,
    combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomised partner).
    1.Il soggetto ha un’età ≥18 anni.
    2.La CDI è confermata da sintomi clinici (vedere Sezione 5.2.3) e dal test rapido di infezione da Clostridium difficile (vedere Sezione 5.7).
    3.Il soggetto non è stato trattato con un farmaco o altra terapia per la CDI negli ultimi 10 giorni.
    4.Il soggetto è sottoposto a:
    •terapia immunosoppressiva (chemioterapia) o a una procedura di trapianto di cellule staminali (definita come il periodo dall’inizio del condizionamento precedente al trapianto a 6 mesi dopo l’infusione delle cellule staminali) per una malignità ematologica; o
    •terapia immunosoppressiva (chemioterapia) per una malignità da tumore solido o in seguito a trapianto di organo solido; o
    •trattamento con una terapia immunosoppressiva e/o una terapia anti-TNF per una malattia autoimmune
    5.Il soggetto ha firmato il consenso informato scritto.
    6.Qualsiasi donna potenzialmente fertile deve essere stata sottoposta a un test di gravidanza sierologico o urinario negativo prima di essere inclusa nello studio.
    7.I soggetti maschili e femminili sessualmente attivi devono essere d’accordo di sottoporsi a un efficace controllo delle nascite durante lo studio e per 30 giorni dopo la conclusione dello stesso. (Un metodo di controllo delle nascite efficace è definito come un metodo associato a un basso tasso di insuccesso (CPMP/ICH/286/95 modificato), inferiore all’1% all’anno con un utilizzo regolare e corretto, per esempio impianti, preparati iniettabili, contraccettivi orali combinati, dispositivi intrauterini (IUD), astinenza sessuale o partner vasectomizzato).
    E.4Principal exclusion criteria
    1.The subject has experienced more than one previous episode of CDI within the 3 months prior to study inclusion.
    2.Taking or requiring to be treated with prohibited medications listed in Section 5.1.3.2.
    3.Unable to take oral study medication.
    4.Female patients that are pregnant, intend to become pregnant or are breastfeeding.
    5.History of ulcerative colitis or Crohn’s disease.
    6.History or diagnosis of toxic megacolon or pseudomembranous colitis.
    7.Not willing to adhere to the provisions of treatment and observation specified in the protocol.
    8.Has taken an investigational drug within 28 days prior to enrollment, or is currently participating in another clinical study which may influence the assessment of efficacy and/or safety endpoints of this study, in the opinion of the Sponsor.
    9.Hypersensitivity to fidaxomicin or any of its components.
    10.Hypersensitivity to vancomycin or any of its components.
    11.Any clinical condition which, in the opinion of the investigator, would not allow safe completion of this study.
    1.Il soggetto è stato esposto a più di un episodio di CDI entro i 3 mesi precedenti l’inclusione nello studio.
    2.Assunzione o necessità di trattamento con farmaci proibiti di cui alla Sezione 5.1.3.2.
    3.Incapacità di assumere il farmaco orale in studio.
    4.Pazienti femminili che sono in gravidanza, pianificano una gravidanza o stanno allattando al seno.
    5.Storia clinica di colite ulcerosa o morbo di Crohn.
    6.Storia clinica o diagnosi di megacolon tossico o colite pseudomembranosa.
    7.Mancata disponibilità ad attenersi alle direttive del trattamento e a quanto specificato nel protocollo.
    8.Il soggetto ha assunto un farmaco sperimentale entro i 28 giorni precedenti l’arruolamento o sta partecipando a un altro studio clinico che potrebbe influenzare la valutazione dell’efficacia e/o degli endpoint di sicurezza di questo studio, secondo l’opinione dello Sponsor.
    9.Ipersensibilità alla fidaxomicina o a uno qualsiasi degli eccipienti.
    10.Ipersensibilità alla vancomicina o a uno qualsiasi degli eccipienti.
    11.Qualsiasi condizione clinica che, secondo l’opinione dello sperimentatore, non consentirebbe di portare a termine questo studio in modo sicuro.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the rate of sustained clinical cure
    14 days after TOC (at Day 26)
    L’endpoint primario sarà la guarigione clinica prolungata a 14 giorni dopo il TOC (Giorno 26)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 26
    Giorno 26
    E.5.2Secondary end point(s)
    N/A
    N/A
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 Yes
    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 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 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 Yes
    E.8.1.7.1Other trial design description
    double dummy
    double dummy
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Russian Federation
    E.8.7Trial has a data monitoring committee Yes
    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
    Visita 4 al giorno 40
    Visita 4 al giorno 40
    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 months14
    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 months13
    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 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: 640
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 512
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    immunocompromized patients
    pazienti immunocompromessi
    F.4 Planned number of subjects to be included
    F.4.1In the member state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 610
    F.4.2.2In the whole clinical trial 640
    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
    nessuno
    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 Decision2012-09-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-19
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-03-13
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