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    Summary
    EudraCT Number:2006-004291-12
    Sponsor's Protocol Code Number:101.1.C.004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-01-07
    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 number2006-004291-12
    A.3Full title of the trial
    '' A multi-national, multi-centre, double-blind,randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated Diarrhea''
    `` A multi-national, multi-centre, double-blind,randomised, parallel group study to compare the safety and efficacy of 200mg PAR-101 taken q12h with 125mg Vancomycin taken q6h for ten days in subjects with Clostridium Difficile-associated Diarrhea``
    A.3.2Name or abbreviated title of the trial where available
    A double-blind, randomized study of PAR-101vs vancomycin in CDAD
    Studio randomizzato in doppio cieco di PAR-101
    A.4.1Sponsor's protocol code number101.1.C.004
    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 SponsorOPTIMER PHARMACEUTICALS INC
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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.3.1Product namePAR-101/OPT-80
    D.3.2Product code PAR-101/OPT-80
    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 codePAR-101/OPT-80
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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 holderViroPharma (US)
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeNon Applicabile
    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
    Patients 16 years old or older who have CDAD as defined by: -Diarrhoea:is defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomization, -Presence of either toxin A or B of C.Difficile in the stool within 48 hours of randomization (for metronidazole failures) or 96 hours of randomization (for subjects with &#8804; 24 hours pretreatment with C. difficile therapy).
    Soggetti di entrambi i sessi, di eta` pari o superiore a 16 anni, con diagnosi di CDAD. Diarrea: definita come una variazione nell`attivita` intestinale abituale, con > 3 evacuazioni intestinali con feci non formate nella 24 ore precedenti la randomizzazione,e Presenza della tossina A o B di C. difficile nelle feci Presenza della tossina A o B di C. difficile nelle feci nelle 48 ore precedenti la randomizzazione (per i falliti al metronidazolo) o nelle 96 ore (per soggetti con <= 24 ore di
    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 10012742
    E.1.2Term Diarrhoea infectious
    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
    Demonstrate that the cure rate of CDAD following treatment with PAR-101/OPT-80 is no worse than that following treatment with vancomycin. Evaluate the safety and tolerability of PAR-101/OPT-80 in subjects with CDAD.
    Dimostrare che il tasso di guarigione della CDAD dopo trattamento con PAR-101/OPT-80 non e' inferiore a quello dopo trattamento con vancomicina. Valutare la sicurezza e la tollerabilita' di PAR-101/OPT-80 in soggetti con CDAD
    E.2.2Secondary objectives of the trial
    Demonstrate that the rate of recurrence of CDAD following treatment with PAR-101/OPT 80 is no worse than that following treatment with vancomycin.
    Dimostrare che il tasso di ricorrenza di CDAD dopo trattamento con PAR-101/OPT-80 non e' inferiore a quello dopo trattamento con vancomicina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female in/outpatients 16 years old or older who have CDAD as defined by: -Diarrhoea:is defined as a change in bowel habits, with >3 unformed bowel movements in the 24 hours prior to randomization, -Presence of either toxin A or B of C.Difficile in the stool within 48 hours of randomization (for metronidazole failures) or 96 hours of randomization (for subjects with &#8804; 24 hours pretreatment with C. difficile therapy). 2. Femalesubjects of childbearing potential must be using an adequate and reliable method of contraception (eg. barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). females who are postmenopausal must have been postmenopausal at least 1 year. Subjects (both male and female)must agree to avoid contraception during treatment and for four weeks following the end of study treatments. 3. All subjects will be required to sign an Informed Consent form. 4. Opiates will be permitted as long as the subjects is on a stable dose at the time of randomization and is expected to mantein this dose during the treatment period: PRN opiate is permitted as long as the total daily dose is not changed during the treatment period. 5. Subjects who have failed at least a full 3-day course of metronidazole but continue to meet the definition of diarrhea without any significant clinical emprovement and remain toxin positive maybe enrolled in the study.
    1. Soggetti di entrambi i sessi, di eta` pari o superiore a 16 anni, con diagnosi di CDAD definita come:¿ Diarrea:una variazione nell`attivita` intestinale abituale, con &gt;3 evacuazioni intestinali con feci non formate nella 24 ore precedenti la randomizzazione, e ¿ Presenza della tossina A o B di C. difficile nelle feci nelle 48 ore precedenti la randomizzazione (per i falliti al metronidazolo) o nelle 96 ore (per soggetti con &#8804; 24 ore di pretrattamento per C. Difficile). 2. I soggetti di sesso femminile in eta` fertile devono adottare un metodo contraccettivo adeguato ed affidabile, ad es. barriera con schiuma o gel spermicida, dispositivo intrauterino, contraccettivo ormonale. Le donne postmenopausali devono essere entrate in postmenopausa da almeno 1 anno. I soggetti di entrambi i sessi devono accettare di evitare il concepimento durante il trattamento e per un periodo di quattro settimane successivo alla fine del trattamento in studio. 3.Tutti i soggetti dovranno firmare un modulo di consenso informato. 4.gli oppiacei saranno permessi se il soggetto avra` un dosaggio stabile al momento della randomizzazione e si prevede di mantenere questo dosaggio durante il periodo di trattamento: l`oppiaceo PRN e` permesso se il totale della dose giornaliera non cambia durante il periodo di trattamento. 5.i soggetti che, dopo almeno 3 giorni pieni di trattamento con metronidazolo, continuano a presentare diarrea come da definizione senza nessun miglioramento clinico significativo e rimangono positivi alla tossina possono essere arruolati nello studio.
    E.4Principal exclusion criteria
    1. Life threatening or fulminant CDAD (WBC>30x109/L; temperature >40C; or evidence of hypotension [systolic blood pressure less than 90 mmHg, and septic shock, peritoneal sign or significant dehydration.) 2. toxic megacolon. 3. Previous exposure to PAR-101/OPT-80. 4. Females who are pregnant or breastfeeding. 5.Likelihood of death within 72 hours from any cause. 6. Concurrent use of: oral vancomycin, metronidazole, oral bacitracin, fusidic acid, rifaximin, nitazoxanide, or related drugs. If the investigator feels the clinical imperative to begin treatment before knowing the laboratory result for stool toxin, up to 4 doses but no more than 24 hours of treatment with metronidazole and/or vancomycin will be allowed. While such pretreated subjects may be enrolled (i.e. no more than 24 hours of previous therapy), it is preferred that subjects who have not received prior CDAD treatment on this admission. 7. The anticipated need to continue other antibacterials for a period exceeding seven days from study start. 8. Subjects who in the opinion of the investigator require other drugs to control diarrhea (e.g. loperamide) or which could affect peristalsis. 9.Unable or unwilling to comply with sudy protocol, including ingesting capsules, having blood drawn, and providing stool samples as scheduled. 10. Participation in other clinical research studies utilising an investigational agent within one month prior to screening or within five half lives of the investigational agent, whichever is longer. 11. History of ulcerative colitis or Crohn's disease. 12. multiple occurrences (defined as more than one prior occurrence) of CDAD within the past three months. Subjects presenting with the first recurrence within the three months may be enrolled.
    1. CDAD che metta in pericolo di vita o fulminante WBC&gt;30x109/L; temperatura &gt;40C; o evidenza di ipotensione [pressione sanguigna sistolica &lt;90 mmHg, shock settico, segni peritoneali o significante disidratazione.) 2. megacolon tossico 3.precedente uso di PAR-101/OPT-80. 4.Donne incinte o nel periodo dell'allattamento. 5. Possibilita' di morte entro 72 ore per qulsiasi causa. 6.Uso corrente di vancomycina, metronidazolo, bacitracina orale, acido fusidico , rifaximina, nitazoxanide, o farmaci correlati.Se lo sperimentatore ritiene imperativo iniziare il trattamento prima di conoscere il risultato di laboratorio per la tossina fecale, saranno permesse fino a 4 dosi di trattamento ma non piu' di 24 ore con metronidazolo e/o vancomycina. Mentre tali soggetti pretrattati possono essere arruolati (cioe' non piu' di 24 ore di terapia precedente), si preferiscono per l'arruolamento i soggetti che non hanno ricevuto prima trattamenti per CDAD. 7.L'esigenza anticipata di continuare con altri antibatterici per un periodo superiore a 7 giorni dall'inizio dello studio. 8.Soggetti che nell'opinione dello sperimentatore richiedano altri farmaci per il controllo della diarrea (cioe' loperamide)o che potrebbero inluenzare la peristalsi. 9.Incapaci o che non vogliono collaborare con il protocollo dello studio, incluso l'ingestire capsule, fare prelievi del sangue e procurare campioni fecali come programmato. 10. Partecipazione ad altri studi clinici utilizzando un prodotto sperimentale un mese prima dello screening. 11.precedente colite ulcerativa o Crohn disease. 12.Molteplici episodi (definiti come piu' di un unico episodio) di CDAD negli ultimi 3 mesi.Soggetti che si presentano con la prima ricorrenza in 3 mesi possono essere arruolati.
    E.5 End points
    E.5.1Primary end point(s)
    Demonstrate that the cure rate of CDADfollowing treatment with PAR-101 is no worse than that following treatment with vancomycin.
    Dimostrare che il tasso di guarigione della CDAD dopo trattamento con PAR-101/OPT-80 non e' inferiore a quello dopo trattamento con vancomicina.
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Ultima visita post-dosaggio (36-40 giorni) dell'ultimo soggetto
    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 months12
    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 months12
    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: 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) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 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 2008-01-07. 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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 664
    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
    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 Decision2007-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-11
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