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    Summary
    EudraCT Number:2008-004847-12
    Sponsor's Protocol Code Number:RABGRD3004
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-02-05
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2008-004847-12
    A.3Full title of the trial
    A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Withdrawal Study to Evaluate the Safety and Efficacy of Delayed-Release Rabeprazole in 1- to 11-Month-Old Pediatric Subjects with Symptomatic/Erosive Gastroesophageal Reflux Disease (GERD)
    A.4.1Sponsor's protocol code numberRABGRD3004
    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 Sodium
    D.3.9.1CAS number 117976-89-3
    D.3.9.2Current sponsor codeR128546
    D.3.9.3Other descriptive nameE3810
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 month old subjects
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy and overall safety of rabeprazole sodium at doses of 5.0 mg and 10.0 mg relative to placebo in infant subjects with GERD who are 1 to 11 months of age at screening.

    The primary efficacy endpoint will be measured by the changes from baseline to the end of the study in the Infant Gastroesophageal Reflux Questionnaire-Revised (I-GERQ-R) total score and the Infant Gastroesophageal Reflux Questionnaire-Daily Diary (I-GERQ-DD) total score between the active treatment and placebo groups.
    E.2.2Secondary objectives of the trial
    To demonstrate (1) the superiority of rabeprazole sodium to placebo with regard to the change in the Regurgitation subscale score, (2) the superiority of rabeprazole sodium to placebo with regard to the change in the Discomfort subscale score and (3) the superiority of rabeprazole sodium to placebo with regard to the change in the Eating Behavior subscale score, all (1, 2 & 3) from the I-GERQ-DD from baseline to the end of the study between the active treatment and placebo groups;

    To demonstrate the superiority of rabeprazole sodium to placebo with regard to the changes in the frequency and volume of regurgitation

    To demonstrate the superiority of rabeprazole sodium to placebo with regard to the change in the weight-for-age Z-score from baseline to the end of the study

    To collect sparse PK samples for a population PK analysis to include with data from previous studies in pediatric and adult subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential subjects must satisfy all of the following criteria to be enrolled in both the open-label and the double-blind treatment periods of the study:

    • Male or female, 1 to 11 months of age, who can be term or post-term infants beyond the neonatal period but less than 12 months of age or preterm infants with a corrected age of at least 44 weeks but less than 12 months;

    • Have a diagnosis of suspected GERD, symptomatic GERD, or endoscopically or histologically proven GERD based on the presence of recurrent vomiting or regurgitation with at least 1 of the following characteristics:
    – Poor weight gain as defined by failure to thrive;
    – Irritability, excessive crying, or disturbed sleep considered abnormal by both the parent(s) and the physician (but not consistent with a diagnosis of colic); and/or
    – Refusal to eat even if hungry or arching back at meals;

    • Body weight between 3.4 and 14.0 kg, inclusive;

    • Have an I-GERQ-R score >16;

    • There is 1 individual (parent, legal guardian, or other individual experienced in the care of the subject) who can be designated as the primary caregiver to complete the daily and weekly assessments and ensure compliance with study drug administration and visit attendance. However, if the subject is not under continuous care of the primary caregiver (eg, attends day care, has a nanny), there is a secondary caregiver who can be delegated to carry out any/all of the primary caregiver's responsibilities. It is anticipated that no additional caregivers will be needed for these purposes during the course of the study.

    • Parents of subjects (preferably both parents, if available) or their legally-acceptable representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to enroll their infant in the study.

    NOTE: Infants who have been receiving thickened feeds as management for GERD symptoms before screening, and whose parent(s) agree to continue administration of the same type of thickened feeds and to record the type and frequency for the duration of the study, are eligible. However, initiation of thickened feeds as management for GERD symptoms during the study is prohibited.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    • History of confirmed acute life-threatening events due to GERD;

    • Documented pyloric stenosis;

    • Have a confirmed diagnosis of cow's milk allergy or eosinophilic gastroenteropathy by biopsy or allergy testing (symptoms include, but are not limited to, diarrhea, rhinitis, atopic dermatitis);

    • Have taken PPIs or H2-blockers within the 3 days before entry into the open-label treatment period;

    • Have taken sucralfate or any medication affecting gastrointestinal motility such as caffeine, baclofen, erythromycin, metoclopramide, digoxin or digitalis preparations, ketoconazole, theophylline, domperidone, carafate, or antacids within 3 days before entry into the open-label treatment period;

    • Have clinically relevant laboratory values outside the normal age-appropriate reference range confirmed by a repeat measurement within 7 days. (If the results of the testing are not within the laboratory’s reference range for the subject’s age, the subject may be included only if the investigator decides the abnormal values are not clinically relevant. Laboratory results performed within 48 hours before screening are
    permitted, in lieu of a repeat laboratory draw);

    • History of organ system disease or any condition that, in the opinion of the investigator, would compromise subject safety;

    • Received an investigational drug or used an investigational medical device within 30 days before the planned start of treatment;

    • The subject's parent(s) or legally-acceptable representative is an employee of the investigator or the study site, with direct involvement in the proposed study, or other studies under the direction of that investigator or the study site, as well as any family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    The 2 co-primary endpoints for this study are the changes from baseline to the end of the study in the I-GERQ-R total score and the I-GERQ-DD total score.
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Withdrawal study
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    As specified in the protocol
    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 months2
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days12
    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) No
    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
    Subjects are between the ages of 1 and 11 months old (inclusive) with endoscopically proven GERD
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    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)
    As described in protocol
    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 Decision2010-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-11-16
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