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 were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    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:2007-000628-41
    Sponsor's Protocol Code Number:D9615C00021
    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 number2007-000628-41
    A.3Full title of the trial
    A Phase I, Randomized, Open-Label, Multi-National Study to Evaluate the Pharmacokinetics of Repeated Once-Daily Intravenous Doses of Esomeprazole in Paediatric Patients 0 to 17 Years Old, Inclusive
    A.4.1Sponsor's protocol code numberD9615C00021
    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 Yes
    D.2.1.1.1Trade name Nexium 40 mg Powder for solution and injection/infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB, 151 85 Sodertalje Sweden
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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 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
    Patients, aged 0-17 years, with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or 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 is to evaluate the pharmacokinetics of repeated doses of esomeprazole given as an once daily (qd) injection over 3 minutes in paediatric patients 0 to 17 years old, inclusive, by assessment of the total area under the plasma concentration versus time curve within a dosing interval (AUCτ) on Day 4 of the study based on population PK modelling.
    E.2.2Secondary objectives of the trial
    • To evaluate the pharmacokinetics of the main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) after repeated doses of esomeprazole given as a once daily injection over 3 minutes in pediatric patients 0 to 17 years old, inclusive.
    • To evaluate the safety
    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.
    2. Patients who are able to comprehend their involvement in a clinical study, including
    the risks and benefits (typically ≥6 years old), must have assent documented, as
    appropriate, by study personnel prior to any study-related procedures. 3. Female and/or male hospitalized patients aged 0 to 17 years old. 4. Patients, who are considered, in the judgement of the investigator, to be a candidate for acid suppression therapy treatment, including, but not limeted to patients with a presumptive diagnosis of GERD, a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD. 5. Patients must weigh at least 1.5 kilograms (kg). 6. For patients 2 to 17 years old, Body Mass Index (BMI) should be calculated and must be between the 5th and 95th percentile for age at inclusion and patients 0 and up to 2 years old, weight and height should be plotted on a standard weight for stature curve, and must be between the 5th and 95th percentile at inclusion. 7. Post-menarchal females must have a negative urine pregnancy test prior to randomisation.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Involvement in the planning and conduct of the study (applies to both AstraZeneca
    staff, staff at the study site, and parents/caretakers) 2. Previous enrolment or randomisation of treatment in the present study 3. Unstable diabetes mellitus. 4. Participation in a clinical study during 28 days prior to the screening visit. Patients who have used investigational devices or products that are not systemically absorbed within 28 days prior to the screening visit should be considered for entry into the study on a case-by-case basis, and discussed with the Sponsor prior to study enrolment. 5. Concomitant use of other PPIs during the treatment with the investigational product. PPIs are allowed up to but not including the day of randomization. 6. Concomitant use of digoxin or iron salts during the treatment with the investigational product. Digoxin and iron salets aare allowed up to but not including the day of randomization. 7.Use of any drug known to affect the PK parameters of esomeprazole within 14 days prior to administration of investigational product on Day 1. A single dose of an excluded medication is allowed up to 7 days prior to administration of study drug on Day 1. These drugs include, but are not limited to the following:
    - enzyme (cytochrome P450) inducers such as phenobarbital (3A inducer), carbamazepine (2C19 & 3A inducer), rifampicin (3A inducer), and St. John’s Wort (3A inducer) - enzyme (cytochrome P450) inhibitors such as clarithromycin (3A inhibitor),
    erythromycin (3A inhibitor), Selective Serotonin Reuptake Inhibitors [(SSRIs) 3A and 2C19 inhibitors], cimetidine (3A and 2C19 inhibitor), itraconazole (3A inhibitors), protease inhibitors (3A4 inhibitors/inducers), and ketaconazole (3A and 2C19 inhibitor). 8. Patients with a history of multiple drug allergies unless otherwise agreed by Investigator and AstraZeneca. 9. Hypersensitivity, allergy, or intolerance to any PPI, any ingredient in any PPI’s formulation, or any drug with a similar chemical structure to any PPI. 10. Any condition that, in the judgement of the investigator, would make performance of any study procedures unsafe, or which would make it unlikely that the patient would complete the study and all study procedures. 11. Any acute or chronic illness or a medical history, which in the opinion of the Investigator and/or Sponsor, could compromise the patient’s safety or successful participation in the study, such as: o- History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. Liver enzymes (AST, ALT, or alkaline phosphatase) or total bilirubin 3 times the upper normal limit, and confirmed by repeat testing that may represent hepatic dysfunction. Benign elevations allowed (eg. Gilbert’s Syndrome and neonatal hyperbilirubinemia).
    -Severe renal disease, including chronic renal disease or impaired renal function
    as manifested by any of the following: serum creatinine outside age adjusted
    local normative values, or markedly abnormal urine sediment on repeated
    examination as judged by the Investigator. - Generalized bleeding disorder (such as abnormalities in clotting factors or platelets), as judged by the Investigator.
    11. Significant cardiac abnormalities (e.g. septal defects) which are expected to significally affect the pharmacokinetics of esomprazole (e.g. elevated pulmonary to systemic flor ratios). 12. Clinically significant abnormal laboratory values, physical examination, or vital signs, which (in the opinion of the investigator) may put the patient at risk when participating in the study, may influence the results of the study, or may affect the patient’s ability to participate in the study. 13. Pregnancy or lactation.
    E.5 End points
    E.5.1Primary end point(s)
    AUCτ for esomeprazole on Day 4 of the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 4 of the study
    E.5.2Secondary end point(s)
    PK sekundary objectives: AUCτ, Css, max, CL/fm, and Vss/fm on Day 4 of the study for the esomeprazole sulphone metabolite and esomeprazole 5-hydroxy metabolite
    Safety: by assessment of adverse events (AEs), laboratory values, blood pressure, heart rate, respiratory rate, body temperature, and electrocardiogram (ECG).
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK evaluation on Day 4 of the study.
    Safety evaluated during the 4 days treatment period and up to the follow-up visit, 28 days 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
    pharmacokinetic, safety
    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 No
    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 trial1
    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
    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: 67
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 6
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 10
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 15
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 36
    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
    The patient's parent/guardian must provide signed, written informed consent. Patients able to comprehend their involvement in a clinical study, including the risks and benefits, must have assent documented prior to any study-related procedures.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Hospitalized patient 0 to 17 years of age who may benefit from acid suppresiontherapy.
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 84
    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
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 27 05:50:51 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA