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    Summary
    EudraCT Number:2011-005203-32
    Sponsor's Protocol Code Number:NERONE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-12-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005203-32
    A.3Full title of the trial
    A prospective, multicenter, open-label, patients with non-erosive gastroesophageal reflux disease (NERD) non-responders to therapy with PPIs
    Studio prospettico, multicentrico, in aperto, su pazienti con malattia da reflusso gastroesofageo non erosiva (NERD) non responder alla terapia con IPP
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study aims to evaluate the true prevalence of patients with non-erosive gastroesophageal reflux disease with symptoms not responding to therapy with proton pump inhibitors
    Lo studio si propone di valutare la reale prevalenza di pazienti con malattia da reflusso gastroesofageo non erosiva che presentano sintomi non rispondenti alla terapia con inibitori della pompa protonica
    A.3.2Name or abbreviated title of the trial where available
    NERONE
    NERONE
    A.4.1Sponsor's protocol code numberNERONE
    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 SponsorUNIVERSITA' CAMPUS BIOMEDICO
    B.1.3.4CountryItaly
    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 supportAstraZeneca
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversita' Campus Bio-Medico di Roma
    B.5.2Functional name of contact pointUO gastroenterologia
    B.5.3 Address:
    B.5.3.1Street Addressvia Alvaro del Portillo, 200
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00128
    B.5.3.4CountryItaly
    B.5.4Telephone number06225411606
    B.5.6E-mailm.cicala@unicampus.it
    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 NEXIUM*30CPR GASTR 40MG
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 INNESOMEPRAZOLE
    D.3.9.1CAS number 119141-88-7
    D.3.9.4EV Substance CodeSUB01960MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    non-erosive gastroesophageal reflux disease and apparently resistant to medical therapy with proton pump inhibitors
    malattia da reflusso gastroesofageo non erosiva e apparentemente resistente alla terapia medica con inibitori della pompa protonica
    E.1.1.1Medical condition in easily understood language
    burning or acidic sensation behind the breastbone often occuring after meals or at night in the supine position, which does not resolve completely with proton pump inhibitor drugs
    bruciore o acidità dietro lo sterno che risale dallo stomaco spesso dopo i pasti o di notte in posizione supina, che non si risolve del tutto con i farmaci inibitori della pompa protonica
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    a) the prospective evaluation of the prevalence data - based on proper compliance, timing, type and dose of PPI - of NERD patients with typical symptoms (vs. atypical and extra-esophageal) resistant or poorly responsive to treatment with esomeprazole 40mg for 8 weeks / day
    a) la valutazione prospettica del dato di prevalenza - corretto in base a compliance, timing, tipo e dose di IPP - dei pazienti NERD con sintomi tipici (vs atipici e extra-esofagei) resistenti o scarsamente sensibili al trattamento per 8 settimane con esomeprazolo 40mg/die
    E.2.2Secondary objectives of the trial
    -evaluation of the prevalence in the group of patients with absent or poor response to PPIs, of patients with FH;
    -evaluation of the characteristics of gastroesophageal reflux, in physical, chemical and dynamic (with pH-impedance), in patients with known resistance to NERD and PPI in patients with functional heartburn.
    -la valutazione della prevalenza, nel gruppo di pazienti con assente o scarsa risposta agli IPP, di pazienti con FH;
    -la valutazione delle caratteristiche del reflusso gastroesofageo, in termini fisico-chimici e dinamici (con pH-impedenzometria), nei pazienti NERD con accertata resistenza ai IPP e nei pazienti con pirosi funzionale.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and women aged between 18 and 70 years with:
    a. Heartburn (GERD symptom) or not associated with atypical symptoms (chest pain, globe, hoarseness, cough, throat tickle "throat clearing"), though the latter correlated to the meal and / or supine position
    • Intensity of symptoms greater than or equal to the score of 3 on a numeric scale (responses 1-3)
    • Presence of symptoms at least 2 times a week, and at least 6 months (with or without previous therapy) (responses 1-3)
    2. Endoscopy negative for the presence of erosions in the esophagus, performed over the past two years, drug washout (H2-antagonists and PPIs) for at least 4 weeks.
    1. Uomini e donne di età compresa fra 18 e 70 anni con:
    a. Pirosi (sintomo tipico da MRGE) associato o meno con sintomi atipici (dolore toracico, globo, raucedine, tosse, vellichio faringeo “throat clearing”), questi ultimi se correlabili al pasto e/o alla posizione supina
    • Intensità dei sintomi superiore o uguale al punteggio di 3 su scala numerica (risposte 1-3)
    • Presenza di sintomi almeno 2 volte alla settimana, e da almeno 6 mesi (con o senza precedenti terapie) (risposte 1-3)
    2. EGDS negativa per presenza di erosioni in esofago, eseguita, nel corso degli ultimi due anni, in wash-out farmacologico (da H2-antagonisti e IPP) da almeno 4 settimane.
    E.4Principal exclusion criteria
    1 History of erosive esophagitis and / or Barrett's Esophagus
    2. Inflammatory bowel diseases
    3. Clinical signs of malabsorption
    4. Previous surgery to the gastrointestinal tract is not included cholecystectomy and appendectomy
    5. Connective tissue diseases (scleroderma, SLE, RA)
    6. Concomitant renal, hepatic, cardiac (angina and AMI)
    7. Chronic concomitant therapy with NSAIDs, aspirin doses of antiplatelet drugs that interact with esomeprazole (eg clopidogrel)
    8. Hypersensitivity / allergic to esomeprazole or its excipients
    9. Pregnancy or breast-feeding during
    10. Previous diagnosis of Post Nasal Drip Cough-related syndrome (PNDS) or bronchial asthma
    11. Neurological diseases (Alzheimer's or Parkinson's disease) or psychiatric (reducing the capacity to understand purpose, possible benefits and potential adverse events resulting from participation in the study, and that could undermine the collaboration involving the study as per protocol), in particular the presence of noise psychotic mental underway.
    12. chronic alcoholism
    1. Storia di esofagite erosiva e/o Esofago di Barrett
    2. Malattie infiammatorie croniche intestinali
    3. Segni clinici di malassorbimento
    4. Pregressi interventi chirurgici a carico del tratto gastrointestinale, esclusa colecistectomia e appendicectomia
    5. Malattie connettivali (sclerodermia, LES, AR)
    6. Concomitanti insufficienze renali, epatiche, cardiaca (angina e IMA)
    7. Terapie croniche concomitanti con FANS, con aspirina a dosi di antiaggregante, con farmaci che interagiscono con esomeprazolo (es. clopidogrel)
    8. Ipersensibilità/allergia ad esomeprazolo o a suoi eccipienti
    9. Gravidanza o allattamento in corso
    10. Pregressa diagnosi di tosse correlata a Post Nasal Drip Syndrome (PNDS) o asma bronchiale
    11. Malattie neurologiche (Alzheimer o Parkinson) o psichiatriche (che riducono la capacità di intendere finalità, possibili benefici e potenziali eventi avversi derivanti dalla partecipazione allo studio, nonché che ne possano minare la collaborazione la partecipazione allo studio come da protocollo) in particolare presenza di disturbi mentali di tipo psicotico in atto.
    12. Alcolismo cronico
    E.5 End points
    E.5.1Primary end point(s)
    a) the prospective evaluation of the prevalence data - based on proper compliance, timing, type and dose of PPI - of NERD patients with typical symptoms (vs. atypical and extra-esophageal) resistant or poorly responsive to treatment with esomeprazole 40mg for 8 weeks / day
    a) la valutazione prospettica del dato di prevalenza - corretto in base a compliance, timing, tipo e dose di IPP - dei pazienti NERD con sintomi tipici (vs atipici e extra-esofagei) resistenti o scarsamente sensibili al trattamento per 8 settimane con esomeprazolo 40mg/die
    E.5.1.1Timepoint(s) of evaluation of this end point
    8 weeks
    8 settimane
    E.5.2Secondary end point(s)
    -la valutazione della prevalenza, nel gruppo di pazienti con assente o scarsa risposta agli IPP, di pazienti con FH;
    -la valutazione delle caratteristiche del reflusso gastroesofageo, in termini fisico-chimici e dinamici (con pH-impedenzometria), nei pazienti NERD con accertata resistenza ai IPP e nei pazienti con pirosi funzionale.
    -la valutazione della prevalenza, nel gruppo di pazienti con assente o scarsa risposta agli IPP, di pazienti con FH;
    -la valutazione delle caratteristiche del reflusso gastroesofageo, in termini fisico-chimici e dinamici (con pH-impedenzometria), nei pazienti NERD con accertata resistenza ai IPP e nei pazienti con pirosi funzionale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 weeks
    10 settimane
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    epidemiology
    epidemiologia
    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 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.8.2.4Number of treatment arms in the trial1
    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 concerned14
    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 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 months0
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 2011-12-16. 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 state593
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 593
    F.4.2.2In the whole clinical trial 593
    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 DIFFERENT FROM NORMAL CLINICAL PRACTICE
    NESSUNO DIVERSO DALLA NORMALE PRATICA CLINICA
    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 Decision2012-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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