Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35236   clinical trials with a EudraCT protocol, of which   5759   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2012-001158-25
    Sponsor's Protocol Code Number:D9614C00094
    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 number2012-001158-25
    A.3Full title of the trial
    A Randomized, Open-Label Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Esomeprazole Magnesium 20 mg and 40 mg in a Pediatric Population of 12 to 17 Year-Olds with Gastroesophageal Reflux Disease (GERD) or Symptoms of GERD.
    A.4.1Sponsor's protocol code numberD9614C00094
    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 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 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 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
    12- to 17-year-olds inclusive with GERD or symptoms of 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 Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    To determine AUC after single and repeated (multiple) oral doses of 20 mg and 40 mg esomeprazole magnesium in 12- to 17-year-olds inclusive with GERD or symptoms of GERD.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To determine the AUC(0-t), Cmax, tmax, t½z, apparent oral clearance (CL/F), apparent volume of distribution during terminal phase (Vz /F), and apparent volume of distribution at steady state (Vss/F) after single and repeated (multiple) oral doses of 20 mg and 40 mg esomeprazole magnesium in 12- to 17-year-olds inclusive with GERD or symptoms of GERD.
    To assess the safety and tolerability of esomeprazole magnesium in 12- to 17-year-olds with GERD or symptoms of GERD.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, all of the following criteria needed to be fulfilled:
    1. Provision of signed written informed consent from subject’s parent/guardian with assent from the subject.
    2. Subjects, both male and female, between the ages of 12 and 17 inclusive.
    3. Subjects must have had a clinical diagnosis of GERD made by the investigator based on any of the following factors: history, physical examination, symptoms identified during review of systems, laboratory test results, or information from diagnostic testing. Notes in the subject’s medical record and/or other source documentation were used to support the diagnosis.
    4. Females must have had a negative pregnancy test at screening and prior to dosing on Day 1 and Day 8.
    5. Females of childbearing potential must have used a reliable form of contraception, other than systemic, hormonal contraceptives, if sexually active.
    6. Subjects were able to swallow capsules.
    7. Subjects were able to tolerate discontinuation of their PPI therapy for 7 days and/or H2RA therapy for 3 days prior to the first dose of study drug and during the study.
    8. Subjects were willing to communicate with the investigator and comply with all study procedures.
    E.4Principal exclusion criteria
    Any of the following was regarded as a criterion for exclusion from the study:
    1. Subjects who had received an experimental compound or participated in another clinical trial within 28 days preceding the screening visit.
    2. Female subjects who were pregnant, wished to become pregnant during the study or were lactating.
    3. Female subjects who were taking a systemic, hormonal contraceptive (eg, oral, parenteral, or transdermal).
    4. Subjects who had a history or presence of GI, hepatic, or renal disease or other condition that could have interfered with absorption, distribution, metabolism or excretion of esomeprazole.
    5. Subjects who had a seizure disorder or unstable diabetes mellitus.
    6. Subjects who had any acute or chronic illness or a medical history, which, in the opinion of the investigator, could have compromised the subject’s safety or successful participation in the study.
    7. Subjects who had a history of multiple drug allergies unless otherwise agreed by AstraZeneca and the investigator.
    8. Hypersensitivity, allergy or intolerance to esomeprazole, any ingredient in its formulation or any drug with a similar chemical structure to esomeprazole.
    9. Subjects who were currently taking anti-epileptic medications, phenytoin, mephenytoin, antineoplastic agents, pro-motility drugs (prokinetics), sucralfate or Warfarin.
    10. Subjects who had taken any drug known to affect the PK of esomeprazole within 14 days prior to screening. These drugs included, but were not limited to, enzyme inducers such as phenobarbital, carbamazepine, rifampicin and St. John’s Wort, or enzyme inhibitors such as clarithromycin, erythromycin, SSRIs, cimetidine, itraconazole, protease inhibitors and ketaconazole.
    11. Subjects who had a history of drug abuse or alcohol dependence or current abuse.
    12. Subjects who were unwilling to take the study drug according to dosing instructions.
    13. Subjects who had clinically significant abnormal values at screening from laboratory measurements, physical examination or vital signs which, in the opinion of the investigator, may have either put the subject at risk when participating in the study, or affected the subject’s ability to participate in the study, other than those directly related to some concurrent and stable disease or if the values from laboratory measurements were both unexplained and potentially significant.
    E.5 End points
    E.5.1Primary end point(s)
    Variables
    - Pharmacokinetic
    Blood samples were analyzed to determine the PK (AUC, AUC(0-t), Cmax, tmax, t½z, CL/F, Vz /F, and Vss /F) of esomeprazole magnesium in the specified population. The AUC was the primary variable.
    - Safety
    Safety and tolerability were assessed by means of incidence and severity of adverse events (AEs), vital signs, laboratory parameters and physical examinations.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PK measurements on dosing day 1 and final dosing day 8. Safety up to 2 weeks post 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 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 trial2
    E.8.3 Will this trial be conducted at a single site globally? Yes
    E.8.4 Will this trial be conducted at multiple sites globally? No
    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 months2
    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: 16
    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: 16
    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 16
    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
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA