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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2010-019064-36
    Sponsor's Protocol Code Number:MA-PY-Hp09-01
    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:2011-11-03
    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 number2010-019064-36
    A.3Full title of the trial
    Eficacia y seguridad de PYLERA (subcitrato potásico de bismuto, metronidazol y clorhidrato de tetraciclina) con omeprazol, administrados 10 días en sujetos con fracaso del tratamiento de erradicación de Helicobacter pylori
    A.4.1Sponsor's protocol code numberMA-PY-Hp09-01
    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 SponsorAxcan Pharma INC
    B.1.3.4CountryCanada
    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 Yes
    D.2.1.1.1Trade name Pylera
    D.2.1.1.2Name of the Marketing Authorisation holderAXCAN PHARMA INC
    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 namePYLERA
    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 INNclorhidrato de tetraciclina
    D.3.9.1CAS number 64-75-5
    D.3.9.3Other descriptive nameclorhidrato de tetraciclina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMetronidazol
    D.3.9.1CAS number 443-48-1
    D.3.9.3Other descriptive nameMetronidazol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsubcitrato potásico de bismuto
    D.3.9.1CAS number 880149-29-1
    D.3.9.3Other descriptive nameSubcitrato potasico de Bismuto
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    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) 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 Yes
    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 No
    D.IMP: 2
    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 LOSEC
    D.2.1.1.2Name of the Marketing Authorisation holderAstrazeneca UK 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.3.1Product nameomeprazol
    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 INNOmeprazol
    D.3.9.1CAS number 73590-58-6
    D.3.9.3Other descriptive nameomeprazol
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) 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 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
    erradicación de Helicobacter pylori
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10019377
    E.1.2Term Helicobacter pylori 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
    Evaluar la tasa de erradicación de Helicobacter pylori (H. pylori) después de tratamiento cuádruple con subcitrato potásico de bismuto, metronidazol y clorhidrato de tetraciclina, administrado junto con metronidazol en sujetos con infección por H. pylori en quienes haya fracasado un ciclo de tratamiento de erradicación con omeprazol-amoxicilina-claritromicina (OAC).
    E.2.2Secondary objectives of the trial
    1. Evaluar el efecto de la resistencia de ¬H. pylori a los antibióticos en la eficacia del tratamiento con PYLERA.
    2. Valorar la seguridad y la tolerabilidad de este régimen terapéutico basándose en los acontecimientos adversos comunicados por los sujetos y observados por el investigador y anomalías analíticas
    3. Comparar los resultados de erradicación en sujetos con y sin presencia o antecedentes de úlcera péptica en el momento basal
    4. Valorar el cumplimiento del tratamiento
    5. Identificar los posibles determinantes del éxito del tratamiento en sujetos resistentes a OAC, como la edad, la resistencia in vitro, el tipo y número de tratamientos y la comorbilidad
    6. Evaluar la utilización de recursos asociada con el fracaso del tratamiento desde tres meses antes del momento basal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Varones o mujeres no embarazadas ni lactantes de 18 años o más.
    2. Las mujeres de edad fértil deberán utilizar un método anticonceptivo médicamente aceptable durante la totalidad del estudio (es decir, desde la selección) y en los 30 días siguientes a este. Se considerará que no están en edad fértil las mujeres posmenopáusicas (sin menstruación durante al menos 12 meses si tienen >50 años, o sin menstruación durante 24 meses si tienen 50 años), esterilizadas quirúrgicamente (ligadura de trompas durante al menos 6 meses, ovariectomía o histerectomía) o con un diagnóstico de infertilidad.
    3. Estado de H. pylori positivo tanto en la prueba del aliento con urea (PAU) marcada con 13C como en la prueba rápida de ureasa (PRU).
    4. Ausencia de erradicación con un ciclo previo de tratamiento OAC, un ciclo previo de tratamiento OAC y un tratamiento complementario, o un ciclo previo de tratamiento OAC y dos tratamientos complementarios.
    5. Presencia de síntomas digestivos altos
    6. Capacidad mental y legal para dar el consentimiento informado escrito
    E.4Principal exclusion criteria
    1. Uso previo de tratamiento combinado de bismuto, metronidazol y tetraciclina para la erradicación de H. pylori
    2. Cirugía previa del aparato digestivo superior (excepto colecistectomía)
    3. Presencia o antecedentes de alteración de importancia clínica de la función renal o hepática o enfermedad hepática
    4. Presencia o antecedentes de enfermedad cardiovascular, pulmonar o endocrina grave o inestable.
    5. Presencia o antecedentes de síndrome de Zollinger-Ellison
    6. Cualquier hematemesis, melena o hemorragia digestiva documentada o anemia ferropénica de importancia clínica actual o reciente de importancia clínica documentada actual o reciente (en el mes previo a la selección)
    7. Enfermedad maligna de cualquier tipo, excepto cáncer de piel tratado con éxito (basocelular o escamocelular), durante los 5 años previos
    8. Esófago de Barrett o displasia de alto grado
    9. Disfagia o vómitos como síntomas importantes
    10. Abuso de drogas, alcohol o medicación en el año previo
    11. Uso continuo de antiulcerosos, incluidos antagonistas de los receptores H2, sucralfato y prostaglandinas, durante las 2 semanas anteriores a la PAU-13C en la selección
    12. Uso continuo de IBP en las 2 semanas anteriores a la PAU-13C en la selección
    13. Uso crónico de antiinflamatorios de esteroideos (AINE), excepto 100 mg diarios o menos de ácido acetilsalicílico
    14. Necesidad de anticoagulantes/inhibidores de la agregación plaquetaria, salvo para prevención de la enfermedad cardiovascular (p. ej., ácido acetilsalicílico a una dosis no superior a 100 mg diarios), y de glucocorticoides sistémicos (debido a la asociación con enfermedad ulcerosa)
    15. Uso de antibióticos sistémicos en los 30 días previos a la selección
    16. Uso regular (> 3 veces por semana) de compuestos de bismuto en los 30 días previos a la selección.
    17. Presencia de una contraindicación o hipersensibilidad para el uso de cualquiera de los principios activos o excipientes contenidos en las medicaciones del estudio facilitadas:
    omeprazol: sujetos con problemas hereditarios raros de intolerancia a la galactosa, deficiencia de lactasa de Lapp, malabsorción de glucosa-galactosa
    bismuto
    metronidazol: trastorno neurológico activo, antecedentes de discrasia sanguínea, hipotiroidismo no corregido, hipoadrenalismo no corregido, alcoholismo, uso concomitante de disulfiram o uso de disulfiram en las dos semanas previas (puede causar reacciones psicóticas)
    tetraciclina
    Maalox Plus: sujetos con problemas hereditarios raros de intolerancia a la fructosa
    18. Uso de cualquier fármaco experimental en los 90 días previos a la selección y durante la totalidad del estudio.
    19. Hipersensibilidad conocida al ácido cítrico o cualquiera de las medicaciones del estudio o acontecimientos adversos previos con ellos.
    20. Sujeto con positividad conocida para el virus de la inmunodeficiencia humana (VIH), la hepatitis u otras enfermedades transmisibles por la sangre o muestras de biopsia
    E.5 End points
    E.5.1Primary end point(s)
    Tasa de erradicación, definida como una PAU-13C negativa realizada al menos 28 días después del tratamiento.
    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 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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 Information not present in EudraCT
    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
    ÚLTIMO PACIENTE, ULTIMA VISITA
    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 months7
    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 months7
    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.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    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)
    No hay un tratamiento especifico o cuidado a efectuar tras la participación del paciente en el estudio
    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 Decision2011-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-01-18
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