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    Summary
    EudraCT Number:2011-006258-99
    Sponsor's Protocol Code Number:ECAMTEHP0012012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-02-10
    Trial 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 number2011-006258-99
    A.3Full title of the trial
    FIRST-LINE ERADICATOR THERAPY OF HELICOBACTER PYLORI INFECTION: OPEN CLINICAL TRIAL, RANDOMIZED, MULTICENTRE, THREE-ARMED, COMPARING THE CLASSICAL TRIPLE THERAPY VERSUS A MODIFIED SEQUENTIAL THERAPY AND A CURRENT THERAPY
    TERAPIA ERRADICADORA DE PRIMERA LÍNEA DE LA INFECCIÓN POR HELICOBACTER PYLORI: ENSAYO CLÍNICO ABIERTO, RANDOMIZADO, MULTICÉNTRICO DE TRES BRAZOS COMPARANDO LA TRIPLE TERAPIA CLÁSICA FRENTE A UN UNA TERAPIA SECUENCIAL MODIFICADA Y UNA TERAPIA CONCOMITANTE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-line eradication treatment of Helicobacter pylori infection: clinical trial without placebo, randomized, multi-center and three parallel treatment groups comparing classic triple therapy versus modified sequential therapy and other concomitant therapy.
    Tratamiento de primera línea erradicador de la infección por Helicobacter Pylori: Ensayo clínico sin placebo, aleatorizado, en varios centros y de tres grupos de tratamiento que comparan la triple terapia clásico frente a otra terapia secuencial modificada y a tratamiento concomitante.
    A.3.2Name or abbreviated title of the trial where available
    ECAMATEHP
    ECAMATEHP
    A.4.1Sponsor's protocol code numberECAMTEHP0012012
    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 SponsorSección de Digestivo. Hospital Comarcal de Laredo
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinisterio de Sanidad. Convocatoria Investigación Independiente 2011
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFIMAV (Instituto de Formación e Investigación Marqués de Valdecilla)
    B.5.2Functional name of contact pointClinical Trial Area
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Cardenal Herrera Oria S/N
    B.5.3.2Town/ citySantander
    B.5.3.3Post code39011
    B.5.3.4CountrySpain
    B.5.4Telephone number34942315515
    B.5.5Fax number34942315517
    B.5.6E-mailifimav.eclinicos1@fmdv.org
    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 Flagyl
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis France
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Tablet
    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 INNMETRONIDAZOLE
    D.3.9.1CAS number 443-48-1
    D.3.9.2Current sponsor codeMetronidazole
    D.3.9.3Other descriptive nameMetronidazole
    D.3.9.4EV Substance CodeSUB08922MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Omeprazol EFG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 EFG
    D.3.2Product code Omeprazol EFG
    D.3.4Pharmaceutical form Capsule
    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.3.9.1CAS number 73590-58-6
    D.3.9.3Other descriptive nameOMEPRAZOLE
    D.3.9.4EV Substance CodeSUB09439MIG
    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) 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: 3
    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 Amoxicilina EFG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAmoxicilina EFG
    D.3.2Product code Amoxicilina EFG
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 61336-70-7
    D.3.9.3Other descriptive nameAMOXICILLIN TRIHYDRATE
    D.3.9.4EV Substance CodeSUB00504MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    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 Claritromicina EFG
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameClaritromicina EFG
    D.3.2Product code Claritromicina EFG
    D.3.4Pharmaceutical form Tablet
    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.3.9.1CAS number 81103-11-9
    D.3.9.3Other descriptive nameCLARITHROMYCIN
    D.3.9.4EV Substance CodeSUB06641MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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
    Clinical situations where it is recommended the eradication of Helicobacter pylori:
    - Gastric or duodenal ulcer (active or not) and duodenal erosions
    - Gastric MALT lymphoma
    - First-degree relatives of patients with gastric cancer
    - Intestinal metaplasia with high-risk histologic criteria
    - Functional dyspepsia whose clinical symptom persists despite treatment with proton pump inhibitors (PPIs) and / or prokinetic
    Situaciones clínicas donde esté recomendada la erradicación de Helicobacter pylori:
    - úlcera gástrica o duodenal (activa o no) y erosiones duodenales
    - linfoma MALT gástrico
    - familiares de primer grado de pacientes con cáncer gástrico
    - metaplasia intestinal con criterio histológico de alto riesgo
    - dispepsia funcional cuya clínica persiste pese al tratamiento sintomático con inhibidores de bomba de protones (IBP) y/o procinéticos
    E.1.1.1Medical condition in easily understood language
    Patients in which H. pylori eradication therapy is recommended: with gastric symptoms, with risk factors or family history
    Pacientes los que se recomienda tratamiento erradicador de H. pylori: síntomas gástricos con factores de riesgo o antecedentes familiares
    E.1.1.2Therapeutic area Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    Evaluation of the efficacy of eradication treatment of Helicobacter pylori. Proportion of eradication of H. pylori assessed at least 4 weeks after treatment is completed by the breath test, or alternatively, by urease test or histology when revision endoscopy is necessary
    Valoración de la eficacia del tratamiento erradicador de Helicobacter Pylori. Proporción de erradicación de H. pylori evaluado al menos 4 semanas después de haber finalizado el tratamiento mediante el test del aliento, o de forma alternativa, cuando se precise endoscopia de revisión, mediante test de ureasa o histología
    E.2.2Secondary objectives of the trial
    Assessment of tolerability (safety) of treatment and monitoring the potential adverse effects
    Valoración de la tolerabilidad (seguridad) de los tratamientos y vigilar la posible aparición de efectos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) All cases of gastric or duodenal ulcer (active or not) and duodenal erosions
    2) Patients diagnosed with gastric MALT lymphoma
    3) First-degree relatives of patients with gastric cancer
    4) Intestinal metaplasia with high-risk histological criteria
    5) Patients with functional dyspepsia with persistent clinical symptomatic despite treatment with inhibitors of the proton pump (IBP) and / or prokinetic
    6) Patients which had given written informed consent
    1) Todos los casos de úlcera gástrica o duodenal (activa o no) y erosiones duodenales
    2) Pacientes diagnosticados de linfoma MALT gástrico
    3) Familiares de primer grado de pacientes con cáncer gástrico
    4) Metaplasia intestinal con criterios histológicos de alto riesgo
    5) Pacientes con dispepsia funcional con clínica persistente pese al tratamiento sintomático con inhibidores de la bomba de protones (IBP) y/o procinéticos
    6) Que den su consentimiento informado por escrito
    E.4Principal exclusion criteria
    1) Age less than 18 or older than 75 years
    2) Advanced chronic disease
    3) Allergy to any medicines included in this study
    4) Previous gastric surgery
    5) Prior eradication treatment
    6) Pregnancy and lactation
    7) Administration of bismuth or antibiotics within the previous 4 weeks
    8) Administration of H2 antagonists or inhibitors of the proton pump (IBP) in the 2 weeks prior to study entry
    1) Edad inferior a 18 años o mayor de 75 años
    2) Enfermedad crónica muy avanzada
    3) Alergia a alguno de los medicamentos
    4) Cirugía gástrica previa
    5) Tratamiento erradicador previo
    6) Embarazo o lactancia
    7) Toma de bismuto o antibióticos en las 4 semanas anteriores
    8) Toma de antagonistas H2 o inhibidores de la bomba de protones (IBP) en las 2 semanas previas a entrar en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy in the eradication of antibiotic treatment in patients infected with Helicobacter pylori by breath test or histology, urease test or endoscopy if you need review
    Eficacia en la erradicación del tratamiento antibiótico en pacientes con infección por Helicobacter pylori mediante el test del aliento o test de ureasa o histología si precisa endoscopia de revisión
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 weeks after the end of the eradication treatment
    A las 4 semanas tras la finalización del tratamiento
    E.5.2Secondary end point(s)
    Checkingl the tolerability and safety of different treatments, ruling out serious adverse events
    Verificar la tolerabilidad de los distintos tratamientos, descartar acontecimientos adversos graves
    E.5.2.1Timepoint(s) of evaluation of this end point
    At least one month follow-up after completion of treatment, further follow-up will be scheduled if needed
    Al menos un mes de seguimiento tras la conclusión del tratamiento, el plazo de seguimiento se ampliara en caso necesario
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 trial3
    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 No
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 180
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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
    Elderly patients (> 65 years old)
    Pacientes ancianos (> 65 años)
    F.4 Planned number of subjects to be included
    F.4.1In the member state300
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 300
    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)
    There is no additional treatment of care scheduled for patients after they have finished their participation in this trial
    No hay tratamiento o cuidados adicionales programados para los pacientes después de que hayan finalizado su participación en este ensayo
    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 Decision2012-04-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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