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    Summary
    EudraCT Number:2006-002001-31
    Sponsor's Protocol Code Number:D9614C00004
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-09
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2006-002001-31
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age
    A.4.1Sponsor's protocol code numberD9614C00004
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/209/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 organisationAstraZeneca
    B.5.2Functional name of contact pointInformation Center
    B.5.6E-mailinformation.center@astrazeneca.com
    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 nameEsomeprazole (oral solution)
    D.3.4Pharmaceutical form Oral solution
    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 SODIUM
    D.3.9.1CAS number 161796-78-7
    D.3.9.4EV Substance CodeSUB20377
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    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
    This Phase III study will evaluate esomeprazole for reducing the esophageal and supraesophageal signs and symptoms of infantile gastro-esophageal reflux disease (GERD) in infants aged 1 to 11 months, inclusive.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    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
    The primary objective of this study was to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms of GERD as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

    E.2.2Secondary objectives of the trial
    The secondary objectives of this study were:
    · to assess the difference between esomeprazole and placebo in the treatment of symptomatic reflux episodes of GERD
    · to assess the difference between esomeprazole and placebo in the treatment of other GERD-related signs and symptoms via video, pH/impedance, and cardiorespiratory monitoring
    · to assess the efficacy of esomeprazole, compared to placebo, in reducing the number of (a) all types of reflux episodes (acid or non-acid) and (b) acidic reflux episodes, defined as pH <4, via pH/impedance monitoring
    · to assess the safety and tolerability of esomeprazole compared to placebo.
    E.2.3Trial contains a sub-study No
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    On an exploratory basis, the study will describe the burden of pediatric GERD on the primary caregiver from a psychological, social, and economic perspective.
    E.3Principal inclusion criteria
    1. Patients’ parent/guardian must provide written informed consent prior to the execution of any study-related procedures (according to local regulations).
    2. Patients must be either a term or post-term infant beyond the neonatal period but less than 12 months of age, or else be a preterm infant with a corrected gestational age of at least 44 weeks but less than 12 months and weigh between 3 kg and 12 kg, inclusive.
    3. Patients must be symptomatic at study entry and have a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD, made by the investigator and based on the following factors: history, physical examination, symptoms identified during review of systems, laboratory test results, or information from diagnostic testing. Notes in patients’ medical records, along with other source documentation, will be used to support the diagnosis. Patients with erosive esophagitis should be evaluated on a case by case basis to determine eligibility for the treatment withdrawal phase of the study.
    4. At least one of the symptoms of GERD must be present for at least twice a week for a 4-week duration in all patients eligible for the study.In addition, these patients, in the opinion of the investigator, have failed a trial of standard anti-reflux measures (thickened feeds, elimination diet, positioning, etc.).
    5. Patients with supraesophageal manifestations of GERD, including wheezing, should present with a clinical picture consistent with GERD.
    6. Infants with GERD clinical symptoms and suspected food allergy, who in the opinion of the investigator, have not responded to standard medical interventions (e.g. elimination diet) after a reasonable amount of time (e.g. 1-2 weeks).
    7. Patients who, in the judgment of the investigator, would be considered for treatment with an acid suppression agent based on symptoms of pathological GER.
    8. Patients and parents/guardians must be able to comply with all study procedures.
    E.4Principal exclusion criteria
    1. Patients who have used a PPI within 7 days prior to enrollment in the open label treatment phase (Day 0).
    2. Patients who have used any prescription or over-the-counter treatment for symptoms of GERD, such as H2RAs or prokinetics, within 24 hours prior to enrollment in the open-label treatment phase (Day 0). Antacids may be used, except for those containing bismuth (e.g., Pepto Bismol® and Kaopectate®).
    3. Patients with a history or a current need for resection or reconstructive surgery of the esophagus, stomach, duodenum, or jejunum.
    4. Patients with a history of acute life-threatening events (ALTEs), e.g. apnea, near SIDS.
    6. Patients with the following active diseases/conditions: gastrointestinal bleed, allergic gastroenteropathies, eosinophilic gastroenteritis bleeding disorders (or a history of these disorders), pyloric stenosis, active seizure disorder, acute pancreatitis, or meningitis.
    7. Patients with any acute or chronic illness that, in the opinion of the investigator, would place the patient at risk because of their participation in the study or potentially confound the study data by including the patient.
    8. Patients with acute respiratory distress within 72 hours prior to enrollment in the open label treatment phase (Day 0). These patients will be eligible to be re evaluated for inclusion once the acute symptoms have subsided. Patients with a recent RSV infection will be excluded unless they have a documented negative RSV test.
    9. Patients with abnormal screening laboratory values, when available, will be
    excluded only if the investigator and/or sponsor determine that the abnormalities are
    unexplainable or are clinically important and would indicate that the patient would
    be at risk from study participation. However, Visit 2 procedures do not have to wait
    for Visit 1 laboratory results.
    10. Patients with any condition that may require surgery during the course of the study.
    11. Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole, omeprazole, or MAALOX or an equivalent age-appropriate non-Bismuth containing liquid antacid.
    12. Patients who have used any other investigational compound within 28 days prior to the screening visit.
    14. Patients whose parent or guardian refuses to sign the informed consent form or is unable to provide fully informed written consent.
    15. Previous enrollment or randomization of treatment in the present study.

    E.5 End points
    E.5.1Primary end point(s)
    Primary: Change from baseline in the number of occurrences of symptoms of GERD, as observed from video recording, and GERD-related signs detected from cardiorespiratory monitoring
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final study treatment day 14
    E.5.2Secondary end point(s)
    Secondary: Change from baseline in the number of occurrences of symptoms of GERD (impedance-detected events with pH <4.0), including only signs and symptoms of GERD temporally associated with reflux episodes
    (+/-2 min, +2 minutes, or +5 minutes after reflux start)
    Change from baseline in the number of occurrences of symptoms of GERD), including only signs and symptoms of GERD temporally associated with weakly acidic (pH 4.0-6.9 inclusive), non-acidic (pH >7.0), and any (acidic, weakly acidic, or non-acidic) reflux episodes (+/ 2 min, +2 minutes, or +5 minutes after reflux start)
    Secondary: Change from baseline in the:
    • number of GERD-related events observed during the video monitoring period by event type and the number of events that coincide with an acid reflux
    • durations of sleep, waking hours, peaceful quietness, and crying observed during the video monitoring period
    • number of GERD-related signs as recorded in the clinical assessment charts
    • Physician Global Assessment (PGA) score of GERD-related symptoms
    Secondary:
    change from baseline from pH/impedance data:
    number of acidic reflux episodes, weakly acidic reflux episodes, non-acidic reflux episodes, liquid reflux episodes, and mixed gas/liquid reflux episodes; and
    mean bolus and mean acid clearance time
    change from baseline from pH data:
    number of acidic reflux episodes (ie, pH <4.0), number of acidic episodes lasting longer than 5 minutes, % time pH <4.0, % time pH 4.0-6.9 (inclusive)

    Safety and tolerability:
    To assess the safety and tolerability of esomeprazole compared to placebo ·Adverse events· Clinical laboratory evaluation· Physical examination· Vital signs
    E.5.2.1Timepoint(s) of evaluation of this end point
    Symptoms relief measarued on Day 14. Safety during the course of the study and up to follow-up visit 14 days after last dosing.
    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 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 No
    E.6.13Others No
    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) Yes
    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.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    Australia
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.2In all countries concerned by the trial months27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 51
    F.1.1.1In Utero Yes
    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) 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
    Patients will be infants aged 1 to 11 months, inclusive. Parents will provide consent
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised: Australia
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