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    Summary
    EudraCT Number:2008-004837-54
    Sponsor's Protocol Code Number:RABGRD3003
    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:2009-01-21
    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 number2008-004837-54
    A.3Full title of the trial
    A Multicenter, 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.4.1Sponsor's protocol code numberRABGRD3003
    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 to 5.0
    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
    Endoscopically proven gastroesophageal reflux disease (GERD) in a paediatric population of 1 to 11 year old subjects.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    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
    The primary objectives of this study are to evaluate the efficacy(endoscopic/histological healing) and safety of 2 dose levels (0.5 mg/kg [10 mg max dose] and 1.0 mg/kg [20 mg max dose]) of a pediatric 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 to11 years of age, with endoscopically proven GERD.
    E.2.2Secondary objectives of the trial
    Short-term phase - to evaluate: changes from baseline of endoscopic & histologic grade; percentage of subjects with improvement in pH>4; change in weekly avg. total GERD symptom score; change in weekly avg. GERD symptom score per symptom; overall GERD symptom relief score; change in percentage of days with any GERD symptom; frequency & amount of antacid use; caregiver rated CGI-I score at the final visit; Global Treatment Satisfaction (GTS) score as determined by the caregiver; to collect sparse PK samples for a population PK analysis of data from this and other studies; and to evaluate the overall safety profiles.
    Long-term maintenance phase - to evaluate: safety associated with maintenance treatment; changes from baseline (of the maintenance phase) to Wk 24 of the following endpoints: histologic grade, symptom severity score & the overall GERD symptom relief score; caregiver-rated CGI-I score at the final visit; and GTS score as determined by the caregiver at the final visit.
    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 the study:
    1) Boy or girl, 1 to 11 years of age
    2) Have a history of at least 1 GERD symptom within the 3 months before the screening phase; these 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) and other (clinical signs and symptoms considered to be GERD-related in the opinion of the investigator);
    3) Positive EGD (Hetzel and Dent classification, grade ≥1 and Histological Features of Reflux Esophagitis scale, grade >0). pHmetry can be performed in addition to the endoscopy if clinically indicated. Assessments have to be done during the 21-day screening period;
    4) The parents (preferably both parents, if available but as required by local
    regulations) or legally acceptable representative 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
    5) Female subjects who have reached menarche, if sexually active, 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 AED 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 β-human chorionic gonadotropin (β-hCG) pregnancy test at screening;
    6) To participate in the optional pharmacogenomic component of this study, parents (preferably both parents, if available, but as required by local
    regulations), or 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). Refusal to consent for this component does not exclude a subject from participation in the clinical study;
    7) Are able to swallow the age-appropriate formulation.
    E.4Principal exclusion criteria
    Potential subjects who meet any of the following criteria will be excluded from participating in the study:
    1) Have a history of or active eosinophilic esophagitis, persistent milk protein allergy, or allergic gastroenteropathy;
    2) Have taken a PPIs or H2 blockers within 3 days before random assignment;
    3) Have taken sucralfate or any medication that affects gastrointestinal motility such as caffeine, baclofen, erythromycin, metoclopramide, digoxin or digitalis preparations, ketoconazole, theophylline and/or domperidone within 3 days before random assignment to study drug;
    4) Subjects infected with H. pylori (as documented by the investigator using validated invasive or noninvasive methods for diagnosis and evidence of active ulceration or recent gastrointestinal bleeding);
    5) Have clinically relevant laboratory values outside the normal age appropriate 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);
    6) Have participated in any investigational drug trial within 30 days before the screening period, during the entire period of this study and 3 days after completion of this study;
    7) Have allergies to PPIs or any inactive ingredients in the study formulation;
    8) Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study;
    9) The subject's parents or legally acceptable representative is an employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Endpoints in Short-term Double-blind Phase:
    The primary efficacy endpoint for the short-term, double-blind treatment phase of the study will be the healing rate by Week 12 (Part 1), or the percentage of subjects with healing by Week 12 (Part 1) where healing is defined as macroscopically normal esophageal mucosa (grade 0 on the Hetzel and Dent classification) or histologic normal esophageal mucosa (grade 0 on the Histological Features of Reflux Esophagitis scale). A logistic regression will be conducted with body weight as covariate, with treatment dose arm and randomization stratification factors as factors. The estimate of the healing rate and the 95% CI will be presented for each treatment dose group. For reference purposes, the healing rates of the 2 dose groups will be compared.

    Endpoints in the Long-term Maintenance Phase:
    The primary efficacy endpoints for the long-term maintenance treatment phase will be macroscopically normal esophageal mucosa (grade 0 on the Hetzel and Dent classification) or histologic normal esophageal mucosa (grade 0 on the Histological Features of Reflux Esophagitis scale). Endoscopic/histologic healing rate and the 95% CI at Week 24 will be estimated.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Pharmacogenomic research participation is optional
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Dose comparison
    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 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
    Specified in protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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
    Subjects are between the ages of 1 year and 11 years 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 state10
    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 Decision2009-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-25
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