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    Summary
    EudraCT Number:2008-004837-54
    Sponsor's Protocol Code Number:RABGRD3003
    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:2009-06-11
    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 number2008-004837-54
    A.3Full title of the trial
    Multi-Center, Double-Blind, Parallel-Group Study to Evaluate Short-Term Safety and Efficacy and Long-term Maintenance of Two Dose Levels of Rabeprazole Sodium Delayed-Release Pediatric Bead Formulation in 1- to 11-Year-Old Pediatric Subjects with Endoscopically Proven GERD
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberRABGRD3003
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 namerabeprazole sodium
    D.3.2Product code R128546
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNRabeprazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGranules for oral suspension
    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
    Pediatric Subjects with Endoscopically Proven GERD
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10017791
    E.1.2Term Gastric irritation
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to evaluate the efficacy (endoscopic/histologic healing) and safety of 2 target dose levels (0.5 mg/kg [10 mg maximum dose] and 1.0 mg/kg [20 mg maximum dose]) of a pediatric micro-bead formulation of rabeprazole sodium (which can be administered orally mixed with food as needed) in a 12-week, parallel-group, double-blind design followed by a long-term safety and efficacy assessment in a 24-week, double-blind maintenance treatment phase in subjects, 1 to 11 years of age, with endoscopically proven GERD.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the short-term treatment phase of the study are to evaluate: the changes from baseline of endoscopic and histologic grade; the percentage of subjects with improvement in pH>4; the change in the weekly average total GERD symptom score; the change in the weekly average GERD symptom score for each symptom; the overall GERD symptom relief score; the change in percentage of days with any GERD symptom; the frequency and amount of antacid use; the parent/caregiver-rated CGI-I score at the final visit (Week 12 [Part 1]); the Global Treatment Satisfaction score as determined by the parent/caregiver; to collect sparse pharmacokinetic (PK) samples for a population PK analysis of data from this and other studies; and the overall safety profiles. For the secondary objectives of the long-term maintenance treatment phase see protocol on p. 10
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    ALTRI SOTTOSTUDI: Ricerca opzionale sul DNA per lo studio die geni correlati al farmaco e alla patologia in studio
    E.3Principal inclusion criteria
    Boy or girl, 1 to 11 years of age; Have a history of at least 1 GERD symptom within the 3 months before the screening phase. Symptoms may include, but are not limited to, heart burn or chest pain, dysphagia or feeding refusal, belching or burping, recurrent regurgitation or vomiting, hoarseness, Sandifer syndrome (cough or abnormal neck posturing), wheezing or stridor, failure to thrive, weight loss or poor weight gain, hematemesis, laryngitis, asthma, and otitis or sinusitis (related to GERD) as well as other clinical signs and symptoms considered to be GERD-related in the opinion of the investigator; Positive EGD (Hetzel and Dent classification, grade >1 and Histological Features of Reflux Esophagitis scale, grade >0) (See Attachment 3 for a description of the grading guidelines and procedure). pHmetry can be performed in addition to the endoscopy if clinically indicated. Assessments have to be done during the 14-day screening period; The parents (preferably both parents, if available) or the legally acceptable representatives of the potential subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically 7 years of age and older) as described in Section 16.2.3, Informed Consent; Female subjects who have reached their menarche must be practicing an effective method of birth control (e.g., abstinence, prescription hormonal contraceptives [provided the subject is receiving a dosage that has been adjusted for concomitant use of an anti-epileptic drug or other drug known to significantly affect the metabolism of hormonal contraceptives], intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study and have a negative urine &amp;#946;-human chorionic gonadotropin (&amp;#946;-hCG) pregnancy test at screening. To participate in the optional pharmacogenomic component of this study, parents (or their legally acceptable representative) of the potential subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study (where local regulations permit). Assent must be obtained from subjects according to local regulations. Refusal to consent for this component does not exclude a subject from participation in the clinical study; Are able to swallow the age-appropriate formulation.
    E.4Principal exclusion criteria
    I principali criteri di esclusione comprendono: una storia di esofagite eosinofila, di allergia persistente alle proteine del latte, o di gastroenteropatia allergica, i soggetti che hanno assunto PPI o H2-bloccanti entro i 3 giorni precedenti l`assegnazione casuale, soggetti che hanno assunto sucralfato o un qualsiasi farmaco in grado di influenzare la motilita` gastrointestinale, come ad esempio caffeina, baclofene, eritromicina, metoclopramide, digossina o preparazioni derivanti da Digitalis, chetoconazolo, teofillina, e/o domperidone, entro 3 giorni dall`inclusione nello studio; soggetti infettati da H. pylori (secondo quanto documentato dallo sperimentatore usando metodiche invasive e non invasive convalidate per la diagnosi ed evidenza di ulcerazione attiva o di emorragia gastrointestinale recente; soggetti che presentano valori di laboratorio che assumano rilievo clinico al di fuori del normale intervallo appropriato per l`eta`, con conferma tramite misurazione ripetuta entro 7 giorni (se i risultati dell`analisi non rientrano nell`intervallo di riferimento del laboratorio per l`eta` del soggetto, quest`ultimo potra` essere incluso unicamente qualora lo sperimentatore decida che i valori anomali non rivestono rilevanza clinica. Invece di una ripetizione del prelievo di laboratorio, sono consentiti risultati di laboratorio ottenuti entro 48 ore dallo screening); soggetti che hanno partecipato a una ricerca vertente su un farmaco sperimentale qualsiasi entro i 30 giorni precedenti il periodo dello screening, per tutta la durata del presente studio e 3 giorni dopo aver completato quest`ultimo; soggetti che manifestano allergie nei confronti dei PPI o di qualsiasi principio inattivo contenuto nella formulazione sperimentale; una qualunque condizione che, a giudizio dello sperimentatore, comprometterebbe il benessere del soggetto o il buon andamento dello studio; il genitore o il rappresentante legalmente accettabile del soggetto e` un dipendente dello sperimentatore o del centro implicato nello studio, con coinvolgimento diretto nella ricerca proposta o in altre eseguite sotto la direzione di tale sperimentatore o centro dello studio, come anche i membri dei nuclei familiari dei dipendenti o dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The evaluation for the primary efficacy endpoints will be the Hetzel and Dent classification and the Histological Features of Reflux Esophagitis scale based on the result of the EGD with biopsy at Week 12 (Part 1) of the short-term treatment phase and at Week 24 (Part 2) of the long-term maintenance treatment phase (Week 36 of the study). Other efficacy evaluations include: GERD symptom and severity scale (symptoms and severity rated daily by the parent/caregiver and recorded in the electronic daily diary); CGI-I score; overall GERD symptom relief, and Global Treatment Satisfaction score as scheduled in the Time and Events Schedule following the Synopsis.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    le ricerca di farmacogenomica e` opzionale
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.3.1Comparator description
    - same IMP used at different dosage
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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 Yes
    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
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    pazienti minori di eta` compresa tra 1-11 anni
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 100
    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 Decision2009-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-25
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