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    Summary
    EudraCT Number:2012-001136-61
    Sponsor's Protocol Code Number:D9614C00098
    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 number2012-001136-61
    A.3Full title of the trial
    A Phase III, Multicenter, Randomized, Double-blind, Parallel-group Study to Evaluate the Safety of Once Daily Esomeprazole for the Treatment of Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive
    A.4.1Sponsor's protocol code numberD9614C00098
    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 nameesomeprazol
    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.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 nameesomeprazol
    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 number40
    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
    Clinically Diagnosed Gastroesophageal Reflux Disease (GERD) in Pediatric and Adolescent Patients 12 to 17 Years of Age, Inclusive
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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: The primary objective of this study was to evaluate the safety and tolerability of once daily treatment with esomeprazole in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD.
    E.2.2Secondary objectives of the trial
    Secondary: The secondary objective of this study was to evaluate the clinical outcome of once daily treatment with esomeprazole in relieving GERD-associated signs and symptoms in pediatric and adolescent patients 12 to 17 years of age, inclusive, with clinically diagnosed GERD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed written informed consent from the patient’s parent/guardian, and assent from the patient prior to conducting any study-related procedures.
    2. Males or females between the age of 12 and 17 years inclusive.
    3. Females of childbearing potential were either not sexually active or were using an adequate birth control method throughout the duration of the study. The investigator determined if the birth control method was adequate on a case-by-case basis. All females of childbearing potential had to have a negative urine pregnancy test at Visit 1 (Screening Visit) and Visit 4 (Study Day 28) to participate or continue to participate. A third urine pregnancy test was performed at the end of the study or Visit 6 (Study Day 56).
    4. Had a clinical diagnosis of GERD made by the investigator based on any of the following factors: medical history including a review of systems, physical examination, laboratory test results, or information from diagnostic testing. Notes in the patient’s medical record along with other source documentation were used to support the diagnosis.
    5. Eligible for treatment with an acid suppression agent, based on investigator-judgement.
    E.4Principal exclusion criteria
    1. PPI use within 14 days prior to randomization (Visit 2), including over-the-counter (OTC) PRILOSEC® (AstraZeneca LP).
    2. Any prescription or OTC treatment use for symptoms of GERD, such as H2RA or prokinetics, within 3 days (72 hours) prior to randomization (Visit 2). Antacids were allowed, except for those containing bismuth.
    3. A history of (within 1 year) or a current need for resectional or reconstructive surgery of the esophagus, stomach, duodenum, or jejunum.
    4. Need for any of the following concomitant medications during the course of the study: bismuth-containing products, barbiturates, anti-convulsants, warfarin, narcotics, antineoplastic agents, H2RAs, sucralfate, anti-emetics (ie, metoclopramide), pro-motility drugs (ie, cisapride), systemic steroids (oral and intravenous), or macrolide antibiotics (such as erythromycin). Use of topical erythromycin was permissible. Occasional doses of nonsteroidal anti-inflammatory drugs (NSAID) or salicylates (3 days) to treat acute conditions was permissible.
    5. Any of the following diseases/conditions: active gastrointestinal bleed, acute peptic ulcer disease, inflammatory bowel disease, allergic gastroenteropathies, eosinophilic gastroenteritis, bleeding disorders, active seizure disorder, ongoing treatment for seizure disorder, acute pancreatitis, metabolic diseases, or meningitis.
    6. Any acute or chronic illness that, in the opinion of the investigator, placed the patient at risk because of their participation in the study or potentially would confound the study data by including the patient. Conditions that were considered for exclusion (however, exclusion was neither required nor limited to): severe cerebral palsy, acute pneumonia, recent trauma, known or suspected abuse or neglect, severe malabsorption, fever of undetermined origin, or any unstable or severe renal, hepatic, cardiac, pulmonary, metabolic or congenital problems that could put the patient at risk by participating in the study. The decision to exclude a patient from study participation in these cases was made by the investigator or AstraZeneca based on the severity of the condition and potential risk to the patient.
    7. H. pylori infection was 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 ulcerations or recent GI bleed, the principal investigator 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 course of treatment.
    8. Acute respiratory distress within 72 hours prior to randomization (Visit 2). These patients were eligible for reevaluation for inclusion once acute symptoms had subsided.
    9. Any condition that required surgery during the course of the study.
    10. A known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
    11. Use of any other investigational compound within 28 days prior to the screening visit. Patients who used investigational devices or products that were not systemically absorbed within 28 days prior to the screening visit were to be discussed with the sponsor on a case-by-case basis prior to randomization (Visit 2).
    12. Any condition that, in the judgment of the investigator, made performance of any of the study procedures unsafe, or which made it unlikely that the patient would complete the study and all study procedures including behavioral problems such as Attention Deficit Disorder or Pervasive Development Disorders.
    13. Had parents who had any condition that, in the judgment of the investigator, made it difficult for the patient to complete the study and all study procedures. Examples included substance abuse or a serious medical condition that compromised the patient’s participation in the study.
    14. Clinically significant abnormal values at screening from laboratory measurements, physical examinations, or vital signs which, in the opinion of the investigator and/or AstraZeneca, would either put the patient at risk when participating in the study or would affect the patient’s ability to participate in the study. In addition, if the values from the laboratory measurements were both unexplained and potentially significant, in the opinion of the investigator and/or AstraZeneca, the patient was excluded. This did not include abnormal values for those directly related to some concurrent and stable disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary variables were the changes from baseline in medical history, physical examinations, clinical laboratory evaluations, and AEs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the course of the study, treatment period 8 weeks and up to 2 weeks post last dosing.
    E.5.2Secondary end point(s)
    Secondary outcome variable
    Assessment of changes from baseline in daily patient symptom assessment as reported by the patient.
    Assessment of changes from baseline in Physician Global Assessment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the 8 weeks treatment period. Last assessement last day of treatment.
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial2
    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
    E.8.9.2In all countries concerned by the trial months6
    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: 140
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 140
    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 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 No
    F.3.3.6.1Details of subjects incapable of giving consent
    All patients (and their parents/guardians) were provided with all the information necessary to make an informed decision
    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 140
    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
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