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    Summary
    EudraCT Number:2004-002370-39
    Sponsor's Protocol Code Number:D9614C00097
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-03-08
    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 number2004-002370-39
    A.3Full title of the trial
    A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease GERD in Pediatric Patients 1 to 11 Years of Age, Inclusive
    A.4.1Sponsor's protocol code numberD9614C00097
    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
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 217087-09-7
    D.3.9.3Other descriptive nameESOMEPRAZOLE MAGNESIUM
    D.3.9.4EV Substance CodeSUB16427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.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 nameesomeprazole
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 217087-09-7
    D.3.9.3Other descriptive nameESOMEPRAZOLE MAGNESIUM
    D.3.9.4EV Substance CodeSUB16427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 3
    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
    D.3.4Pharmaceutical form Capsule, hard
    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.3.9.1CAS number 217087-09-7
    D.3.9.3Other descriptive nameESOMEPRAZOLE MAGNESIUM
    D.3.9.4EV Substance CodeSUB16427MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Gastroesophageal Reflux Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10017885
    E.1.2Term Gastrooesophageal reflux disease
    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
    Primary: to evaluate the safety of once daily treatment with esomeprazole in relieving GERD-associated symptoms in pediatric patients 1 to 11 years of age, inclusive.
    E.2.2Secondary objectives of the trial
    Secondary: to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric patients 1 to 11 years of age, inclusive.
    Exploratory: to describe the burden of pediatric GERD in children ages 1 to 5 years of age, inclusive on the parent/guardian from a psychological, social, and economic perspective.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, patients (or their parents/guardians when applicable) had to fulfill all of the following criteria;
    1. Patients’ parents/guardians must have provided written informed consent prior to the execution of any study-related procedures.
    2. Patients who were able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have had assent documented by study personnel prior to any study-related procedures.
    3. Patients were males or females between 1 and 11 years of age, inclusive and must have weighed ≥8 kg.
    4. Patients must have been diagnosed with endoscopically proven GERD by the investigator during the screening period. Patients with a previous (within 2 weeks prior to Visit 1) diagnosis of EE by endoscopy and who were candidates for PPI therapy were not required to have an additional endoscopy at baseline (Visit 1). The established endoscopic evidence was accepted only if there was adequate documentation (ie, complete endoscopic reports, photo documentation). Patients with extraesophageal and/or atypical symptoms (ie, failure to thrive, reactive airway disease, etc.) who were candidates for endoscopy qualified for inclusion provided they had endoscopic signs of GERD.
    5. Patients who, in the judgment of the investigator, would be considered for treatment with a PPI based on symptoms of pathological GER.
    6. Postmenarchal females must have had a negative urine pregnancy test at the time of the screening visit.
    E.4Principal exclusion criteria
    Any of the following was regarded as a criterion for exclusion from the study:
    1. Patients who had used a PPI within 7 days prior to randomization (Day 0), including over-the-counter (OTC) omeprazole.
    2. Patients who had used any prescription or OTC treatment (other than PPIs) for symptoms of GERD, such as H2RAs or prokinetics, within 72 hours prior to randomization (Day 0). Antacids could have been used, except for those containing bismuth (eg, PEPTO BISMOL® [Procter&Gamble, Cincinnati OH, USA] and Kaopectate® [Pfizer Consumer Healthcare, Morris Plains NJ, USA]).
    3. Patients who had a history or current need for resectional or reconstructive surgery of the GI tract (eg, esophagus, stomach, duodenum, jejunum, or colon).
    4. Female patients who were taking hormonal contraceptives for medical reasons.
    5. Patients who needed to remain on any of the following concomitant medications during the course of the study: bismuth-containing products, barbiturates, anticonvulsants, anticoagulants, narcotics, antineoplastic agents, H2RAs, sucralfate, anti-emetics, systemic steroids (oral and intravenous), pro-motility drugs (eg, cisapride, metoclopramide, domperidone) or macrolide antibiotics such as erythromycin. Use of topical erythromycin was permissible. Occasional doses of nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates (≤3 days) to treat acute conditions were permissible.
    6. Patients who had the following diseases/conditions: active gastrointestinal bleed, active peptic ulcer disease, eosinophilic gastroenteritis, allergic gastroenteropathies, inflammatory bowel disease, bleeding disorders, seizure disorders, acute pancreatitis, metabolic diseases or meningitis. Patients who had a past history (prior to study enrollment) of EE, Duodenal Ulcers (DU), Gastric Ulcers (GU) and/or H. pylori infection were eligible for this study if they satisfied other inclusion/exclusion criteria.
    7. Patients with H. pylori infection were evaluated on a case-by-case basis. Absolute exclusions were those children with active gastric or duodenal ulceration associated with H. pylori. If there was no documentation of active ulceration or recent GI bleed, the principal investigator (PI) could have, at their discretion, planned for their anti-Helicobacter antibiotic course after this study was completed, provided the patient’s parents/guardian agreed with the course of treatment.
    8. The patient’s endoscopic findings had evidence of advanced esophageal lesions due to GERD or other severe upper GI tract pathology (eg, Barrett’s, stricture, neoplasm).
    9. Patients who had other major clinical pathology or developmental abnormalities (eg, including but not limited to esophageal atresia, pyloric stenosis), which might have caused gastrointestinal dysmotility as a secondary manifestation.
    10. Patients who had acute respiratory distress within 72 hours prior to randomization (Day 0). These patients were eligible for re-evaluation for inclusion once acute symptoms had subsided.
    11. Patients who had abnormal screening laboratory values were excluded when the investigator and/or AstraZeneca determined the abnormalities to be unexplained or clinically significant in a way that would put the patient at risk during study participation.
    12. Patients who had any condition that might require major surgery during the course of the study.
    13. Patients who had a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
    14. Patients who had used any other investigational compound within 28 days prior to the screening visit. Patients who had used investigational devices or products that were not systemically absorbed within 28 days prior to the screening visit were to be discussed with AstraZeneca on a case-by-case basis prior to randomization (Day 0).
    15. Patients who had any condition that, in the judgment of the investigator, made performance of any of the study procedures unsafe, or that made it unlikely the patient would complete the study and all study procedures. These conditions may have included behavioral problems such as Attention Deficit Disorder (ADD) or Pervasive Development Disorders.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study was to evaluate the safety of once daily esomeprazole for the treatment of endoscopically proven GERD and GERD-associated symptoms in pediatric patients ages 1 to 11 years, inclusive. The safety variables assessed were changes from baseline in adverse events, clinical laboratory evaluations, physical examination (including medical history), vital signs, and other safety variables.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety was assessed during the course of the study and up to 2 weeks post the treatment period
    E.5.2Secondary end point(s)
    Secondary outcome variable
    To evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD (gastroesophageal reflux disease)-associated symptoms in pediatric patients ages 1 to 11 years, inclusive.
    -changes from baseline in Physician’s Global Assessment
    -changes from baseline in daily patient symptom assessments as reported by parent/guardian
    -changes from baseline in endoscopic healing of EE (erosive esophagitis)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Symptoms assessment and Physician's Assessement was done during the course of the treatment period.
    Endoscopic evaluation was performed on the last treament visit, Day 56.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 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
    United States
    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 years1
    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: 26
    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 No
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 No
    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 50
    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: United States
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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