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    Summary
    EudraCT Number:2009-015885-75
    Sponsor's Protocol Code Number:RABGRD1005
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-24
    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 ConcernedGermany - BfArM
    A.2EudraCT number2009-015885-75
    A.3Full title of the trial
    A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks with a Presumptive Diagnosis of GERD
    A.4.1Sponsor's protocol code numberRABGRD1005
    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
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    Nasogastric use (Noncurrent)
    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 number1.0
    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.IMP: 2
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    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
    Gastroesophageal reflux disease (GERD) in neonates and pre-term infants, with a corrected age of less than 44 weeks at the time of the first dose.
    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
    The objective of this study is to evaluate the pharmacokinetics (PK) using population PK methods, pharmacodynamics (PD) (intraesophageal and intragastric pH, assessment of the overall treatment effect [OTE] [overall GERD symptom relief]) and the short-term safety of rabeprazole after single and multiple dose administration for up to 28 days at one low dose level (Part 1) and two presumed effective dose levels (Part 2) in neonates and pre-term infants, with a corrected age of less than 44 weeks at the time of the first dose, who have been diagnosed with GERD.

    As this study is an exploratory assessment of the population PK, PD and short-term safety of rabeprazole in neonates and pre-term infants, no formal hypothesis testing is applied.
    E.2.2Secondary objectives of the trial
    no secondary obiectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Potential subjects must meet all of the following criteria to participate in the study:
    • Subjects must be an inpatient in a neonatal intensive care unit (NICU) or step down unit and must need a
    feeding tube (6 French nasogastric or orogastric) in place for enteral alimentation (complete or partial). Partial
    oral feedings are allowed.
    • Subjects participating in the pHmetry assessment must be in need of this assessment for their clinical
    management in the opinion of the Investigator.
    • Male and female neonates or pre-term infants, with a corrected age of less than 44 weeks at the time of the
    first dose, with a minimum weight of 0.8 kg at screening and with a presumptive diagnosis of GERD based on
    at least one of the following symptoms: recurrent regurgitation, a failure to thrive, coughing, grimacing and
    discomfort with feeding, an arching position related to feeding, presumed GERD-associated apneic events (apnea
    or bradycardia episodes associated with oxygen desaturation deemed related to feeding), feeding intolerance
    manifested by recurrent emesis, regurgitation and irritability, presumed or documented lung aspiration, irritability
    and apparent discomfort associated with feedings, recurrent pneumonia, recurrent bronchopulmonary disease
    exacerbated by GERD and observed milk in the mouth or oropharynx.
    • Subjects who have been treated with, or are currently receiving a PPI, H2-blockers or antacids are eligible,
    provided they can discontinue the PPIs and H2-blockers for 3 days before dosing and remain off these
    medications for the duration of the treatment phase. Cimetidine must be discontinued for at least 7 days prior to
    dosing. The use of antacids will be allowed until 24 hours before dosing and can be used as a substitute for PPIs
    and H2 blockers until 24 hours before dosing.
    • Subjects should be generally stable, other than for the presence of GERD.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria will be excluded from participating in the study:
    • A history of or current clinically significant medical illness (excluding GERD, asthma, reactive airway disease or cystic fibrosis-dependant GERD) in the opinion of the investigator that should exclude the subject or which could interfere with the interpretation of the study results.
    • Continuous drip tube feeding with formula or breast milk (bolus feedings separated by at least 3 hours will be allowed).
    • Subjects whose mothers are taking PPIs and who are pumping breast milk to be fed to their infants.
    • Continuous positive airway pressure (CPAP) delivered via nasal prong or oral mask. CPAP delivered via an endotracheal tube will be allowed.
    • Serum concentrations of hepatic transaminases > 3-fold higher than the upper limit of normal for age. Creatinine values ≥ 106 μmol/L (≥1.2 mg/dL).
    • Clinically relevant laboratory values outside of the normal age appropriate range for the infant based on local laboratory values accepted by the investigator. 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 that the
    abnormal values are not clinically significant. Laboratory results obtained as part of the subject’s routine clinical care in the NICU, if performed within 72 hours prior to screening are allowed, in lieu of an additional blood draw for study laboratory determinations. However, if the normal practice in the neonatal intensive care unit
    does not include all the protocol-specified laboratory tests, the per-protocol tests must be performed during the screening and end of study phases even if that requires an additional blood draw.
    • Participation in any clinical study with a study drug or medical device within 30 days or a period less than 10 times the half-life of the respective study drug (if known), whichever is longer, before the first dose of this study drug is scheduled. Exceptions to this include experimental surfactant therapy, short term single dose studies requiring less than 0.2 mL blood draw volume with experimental treatment more than 3 days from the start of this study’s treatment, or any other needed intervention that, in the opinion of the investigator, will not affect the results of the current study.
    • Treatment with full therapeutic doses of sucralfate or any medication that affects gastrointestinal motility such as baclofen, erythromycin, metoclopramide, cisapride, or domperidone. In addition, digoxin or digitalis preparations and ketoconazole will be excluded within 3 days prior to dosing (or a shorter washout period if agreed to by the investigator and the sponsor). Antacids are allowed to be continued up to 24 hours prior to dosing. Treatment with a PPI or H2-blocker is not allowed within 72 hours prior to dosing; cimetidine should be discontinued for at least 7 days prior to dosing. If PPIs or H2-blockers are discontinued 72 hours prior to dosing, antacids may be substituted for the first 48 hours of that 72 hour washout period, but then must be discontinued for at least 24 hours prior to dosing.
    • If a subject has been treated with any drug that may be considered a CYP3A4 inhibitor or inducer within 7 days of the start of treatment with rabeprazole sodium, the investigator should contact the sponsor to discuss and make a decision on the exclusion of that subject.
    • A history of allergy or sensitivity to PPIs or to their inactive ingredients.
    • The subject’s parent or legally acceptable representative (hereafter referred to as parent) is an employee of the investigator or the study center, with direct involvement in the proposed study or other studies under the direction of that investigator of the study center, as well as any family members of the employees or the investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Subjects will undergo a series of assessments during the course of the study to evaluate the pharmacokinetics, pharmacodynamics and the short-term safety of rabeprazole. A subject will be considered to have completed the study if the subject has completed all required assessments and received at least 5 doses of the study
    drug.
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Pharmacokinetic, Pharmacodynamic and Short-term Safety Study
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    provided 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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.3Newborns (0-27 days) Yes
    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) 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 neonates and pre-term infants with a corrected age of less than 44
    weeks at the time of the first dose
    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 25
    F.4.2.2In the whole clinical trial 60
    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)
    not different from the expected normal treatment of that condition
    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 Decision2010-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-01-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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