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    Summary
    EudraCT Number:2012-001156-19
    Sponsor's Protocol Code Number:D9614C00007
    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 number2012-001156-19
    A.3Full title of the trial
    A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single Oral Doses of Esomeprazole Magnesium in Pediatric Patients 1 to 11 Years-Old Inclusive with Endoscopically-Proven Gastroesophageal Reflux Disease (GERD)
    A.4.1Sponsor's protocol code numberD9614C00007
    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 LP
    B.1.3.4CountryUnited States
    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
    Pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.
    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
    The primary objective of the study was to determine the area under the plasma concentration time curve (AUC) of esomeprazole after single oral doses of 5 mg, 10 mg, or 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically proven GERD.
    E.2.2Secondary objectives of the trial
    The secondary objectives were as follows:
    1. To determine the area under the plasma concentration time curve from time zero to the last quantifiable concentration (AUC(0 t)), maximum plasma concentration (Cmax), time to reach Cmax (tmax), terminal half life (t1/2λz), apparent oral clearance (CL/F), and apparent volume of distribution during terminal phase (Vλz/F) of esomeprazole after single oral doses of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.
    2. To determine AUC, AUC(0 t), Cmax, tmax, and t1/2λz of the 5-hydroxy and sulphone metabolites of esomeprazole after a single oral dose of 5 mg, 10 mg, and 20 mg esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically proven GERD.
    3. To assess the safety and tolerability of esomeprazole in pediatric patients 1 to 11 years old, inclusive, with endoscopically-proven GERD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, patients had to fulfill all of the following criteria:
    1. Provide signed, written informed consent from patient’s parent/guardian with assent from the patient, if appropriate
    2. Patients were between the ages of 1 and 11, inclusive, and able to take solid or bland food (eg, applesauce)
    3. Patients weighed at least 8 kg and, at the investigator’s discretion, were able to undergo extraction of an adequate volume of blood
    4. The patient’s weight for height percentile should have been less than the 90th percentile or the body mass index (BMI) must have been between the 5th and 95th percentile for age.
    5. Patients were diagnosed with endoscopically proven GERD by the investigator during the screening period (Visit 1). In addition, patients with a previous (within 42 days of Visit 1) endoscopic diagnosis of GERD induced esophagitis were not required to have another endoscopy to be enrolled into this study. Patients weighing <20 kg with a previous endoscopy performed within 90 days of Visit 1 were eligible for enrollment. The diagnosis of esophagitis could have been made by the Principal Investigator or referred from other endoscopy specialists or centers. Endoscopic evidence was accepted if there was adequate documentation (ie, complete endoscopic reports, pathology reports, or photo documentation). Patients with extra esophageal 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.
    6. Patients were not to take any prescription or over the counter (OTC) PPIs for 7 days and/or H2RA therapy for 3 days before the dose of the study drug through completion of study procedures on Day 1. Resumption of treatment with PPIs and H2RAs was at the discretion of the investigator.
    7. Patients/parents/guardians must have been willing to communicate with the investigator and comply with all study procedures.
    8. Post menarchal females must have had a negative urine pregnancy test at the time of randomization on Day 1.
    E.4Principal exclusion criteria
    Any of the following was regarded as a criterion for exclusion from the study:
    1. Use of any other investigational compound or participation in another clinical trial within 28 days before the screening visit.
    2. History or presence of gastrointestinal (GI), hepatic, or renal disease, or other conditions that could interfere with absorption, distribution, metabolism, or excretion of esomeprazole.
    3. Unstable diabetes mellitus or history of seizure disorder.
    4. Any acute or chronic illness or a medical history, which in the opinion of the investigator and/or sponsor, could have compromised the patient’s safety or successful participation in the study.
    5. Patients with the following diseases/conditions:active GI bleed, active peptic ulcer disease, eosinophilic gastroenteritis, allergic gastroenteropathies, inflammatory bowel disease, bleeding disorders, seizure disorders, acute pancreatitis, metabolic diseases, or meningitis. Patients with a past history (before study enrollment) of erosive esophagitis (EE), duodenal ulcers (DU), gastric ulcers (GU) and/or Helicobacter pylori (H. pylori) infection were eligible for this study if they satisfied other inclusion/exclusion criteria. Patients with active H. pylori infection may have been enrolled into the study provided anti Helicobacter antibiotic therapy was withheld until after the study was completed. This decision was made at the investigator’s discretion and with agreement from the patient’s parent/guardian.
    6. Female patients who were taking hormonal contraceptives for medical reasons.
    7. Patients who must have remained on any of the following concomitant medications during the course of the study: bismuth containing products, barbiturates, anti convulsants, anti coagulants, narcotics, anti neoplastic 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 or salicylates (3 days) to treat acute conditions were permissible.
    8. The patient’s endoscopic findings must have had no evidence of advanced esophageal lesions due to GERD or other severe upper GI tract pathology (eg, Barrett’s, stricture, neoplasm).
    9. Patients with a history or a current need for resectional or reconstructive surgery of the GI tract (eg, esophagus, stomach, duodenum, jejunum, or colon) were excluded except for those who required surgery for a diagnosis of esophageal atresia (any variant) or pyloric stenosis.
    10. History of multiple drug allergies unless otherwise agreed by AstraZeneca and the investigator.
    11. Hypersensitivity, allergy, or intolerance to esomeprazole, any ingredient in its formulation or any drug with a similar chemical structure to esomeprazole.
    12. Current use of anti epileptic medications phenytoin, mephenytoin, antineoplastic agents, pro motility drugs (prokinetics), sucralfate, or warfarin.
    13. Use of any drug known to affect the pharmacokinetic parameters of esomeprazole within 14 days before administration of study drug on Day 1. These drugs included, but were not limited to, enzyme inducers such as phenobarbital, carbamazepine, rifampin, and St. John’s Wort, or enzyme inhibitors such as clarithromycin, erythromycin, selective serotonin re uptake inhibitors, cimetidine, itraconazole, protease inhibitors, and ketaconazole.
    14. Clinically significant abnormal values at screening from laboratory measurements, vital signs, or other physical examination findings other than those directly related to some concurrent and stable disease, which, in the investigator’s opinion, may have either put the patient at risk when participating in the study or were both unexplained and clinically significant.
    E.5 End points
    E.5.1Primary end point(s)
    Variables
    - Pharmacokinetic
    Blood samples were analyzed to determine the pharmacokinetics of esomeprazole (AUC, AUC(0 t), Cmax, tmax, t1/2λz, CL/F, Vλz/F) and its 5 hydroxy and sulphone metabolites (AUC, AUC(0 t), Cmax, tmax, t1/2λz).
    - Safety
    Safety and tolerability were evaluated from the incidence and severity of all adverse events and the assessment of laboratory parameters, vital signs measurements, and physical examination findings
    E.5.1.1Timepoint(s) of evaluation of this end point
    During the course of the study. Treatment one day. Safety follow-up up to 2 weeks post 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 No
    E.6.6Pharmacokinetic Yes
    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) Yes
    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) No
    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 trial4
    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 Yes
    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 years2
    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: 28
    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.1.1.4.1Number of subjects for this age range: 7
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 21
    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 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.3.3.7Others 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 28
    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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