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    The EU Clinical Trials Register currently displays   35443   clinical trials with a EudraCT protocol, of which   5820   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004291-12
    Sponsor's Protocol Code Number:101.1.C.004
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-20
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2006-004291-12
    A.3Full title of the trial
    ESTUDIO MULTINACIONAL, MULTICÉNTRICO, DOBLE CIEGO, ALEATORIZADO Y DE GRUPOS PARALELOS PARA COMPARAR LA SEGURIDAD Y LA EFICACIA DE 200 mg DE PAR-101 CADA 12 HORAS CON 125 mg DE VANCOMICINA CADA 6 HORAS DURANTE DIEZ DÍAS EN SUJETOS CON DIARREA ASOCIADA A CLOSTRIDIUM DIFFICILE

    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, randomised study of PAR−101 vs vancomycin in CDAD
    A.4.1Sponsor's protocol code number101.1.C.004
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPar Pharmaceutical, 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
    B.Sponsor: 2
    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 Information not present in EudraCT
    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 873857-62-6
    D.3.9.2Current sponsor codePAR-101/OPT-80
    D.3.9.3Other descriptive namediffimicin
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeAntibiotic
    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.3.1Product nameVancomycin
    D.3.2Product code Vancomycin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 1404906
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeAntibiotic
    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
    DIARREA ASOCIADA A CLOSTRIDIUM DIFFICILE
    Clostridium difficile associated diarrhoea (CDAD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10012748
    E.1.2Term Diarrhoea, Clostridium difficile
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demostrar que el índice de curación de la diarrea asociada a Clostridium difficile tras el tratamiento con PAR-101 no es peor que el índice de curación tras el tratamiento con vancomicina,

    Evaluar la seguridad y tolerabilidad de PAR-101 en sujetos con diarrea asociada a Clostridium difficile.
    E.2.2Secondary objectives of the trial
    Demostrar que el índice de recidiva de la diarrea asociada a Clostridium difficile tras el tratamiento con PAR-101 no es peor que el índice de recidiva tras el tratamiento con vancomicina.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hombres o mujeres hospitalizados/ambulatorios de 16 años o mayores con diarrea asociada a Clostridium difficile conforme a las siguientes definiciones:
    • Diarrea: se define como un cambio en los hábitos de defecación, con >3 deposiciones blandas en las 24 horas anteriores a la aleatorización, y
    •Presencia de toxina A o B de C. difficile en las heces en 48 horas de la aleatorización.

    2. Las mujeres en edad fértil deberán utilizar un método anticonceptivo adecuado y fiable (p. ej.: barrera con espuma o gel espermicida adicional, dispositivo intrauterino, anticonceptivos hormonales). Las mujeres posmenopáusicas deberán llevar posmenopáusicas ≥1 año. Los sujetos (tanto hombres como mujeres) deberán estar de acuerdo en evitar el embarazo durante el tratamiento y durante cuatro semanas tras finalizar el tratamiento del estudio.

    3. Todos los sujetos tendrán que firmar un documento de consentimiento informado.

    4. Los opiáceos estarán permitidos siempre que el sujeto tome una dosis estable en el momento de la aleatorización y se espere que mantenga esta dosis durante el período de tratamiento.
    • Los opiáceos a demanda están permitidos siempre que la dosis total diaria no cambie durante el período de tratamiento.

    5. Los sujetos que hayan fracasado con al menos un ciclo completo de 3 días de metronidazol pero que sigan satisfaciendo la definición de diarrea sin ninguna mejoría clínica significativa y permanezcan positivos para toxinas podrán inscribirse en el estudio.
    E.4Principal exclusion criteria
    1. Diarrea asociada a Clostridium difficile potencialmente mortal o fulminante (leucocitos >30 x 109/l; temperatura >40°C; o indicios de hipotensión [tensión arterial sistólica inferior a 90 mm Hg], y choque septicémico, signos peritoneales o deshidratación significativa).

    2. Megacolon tóxico.

    3. Exposición previa a PAR-101.

    4. Mujeres embarazadas o en período de lactancia.

    5. Probabilidad de fallecimiento en el plazo de 72 horas por cualquier causa.

    6. Uso concurrente de: vancomicina por vía oral, metronidazol, bacitracina por vía oral, ácido fusídico, rifaximina, nitazoxanida o medicamentos relacionados. Si el investigador lo considera clínicamente imperativo comenzar el tratamiento antes de saber el resultado de laboratorio para toxinas en heces, se permitirán hasta 4 dosis, pero no más de 24 horas de tratamiento con metronidazol y/o vancomicina. Aunque los sujetos previamente tratados podrán inscribirse (es decir, no más de 24 horas de terapia previa), es preferible incluir a sujetos que no hayan recibido tratamiento previo para la diarrea asociada a Clostridium difficile en esta inclusión. Siempre que sea posible, se recomienda que los investigadores identifiquen a los sujetos elegibles antes de la administración de otras terapias y que “sensibilicen” a su centro en relación con este estudio para poder inscribir a sujetos sin terapia previa.

    7. Necesidad prevista de continuar otros antibacterianos durante un período superior a siete días a partir del comienzo del estudio.

    8. Los sujetos que en opinión del investigador requieran otros medicamentos para controlar la diarrea (por ej.: loperamida) o que puedan afectar al peristaltismo.

    9. No puede o no quiere cumplir con el protocolo del estudio, incluyendo ingesta de cápsulas, extracciones de sangre o proporcionar una muestra de heces conforme al programa.

    10. Participación en otros estudios de investigación clínica utilizando un agente en fase de investigación en el mes anterior a la selección o en cinco semividas del agente en fase de investigación, cualquiera que sea el período más largo.

    11. Historia de colitis ulcerosa o enfermedad de Crohn.

    12. Episodios múltiples (definidos como más de un episodio anterior) de diarrea asociada a Clostridium difficile en los últimos tres meses. Los sujetos que acudan con la primera recidiva en los últimos 3 meses podrán inscribirse.

    13. No se incluirá a los sujetos que el investigador cree inapropiados para el ensayo, p. ej.: sujetos con hipersensibilidad conocida a la vancomicina.
    E.5 End points
    E.5.1Primary end point(s)
    Índices principales de curación (respuesta principal) en las poblaciones microbiológicamente evaluable y con intención de tratamiento modificada (mITT)
    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 Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    vancomycin
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    Last post-dose visit (days 36-40) of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 332
    F.4.2.2In the whole clinical trial 664
    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 Decision2007-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-12-11
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