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    Summary
    EudraCT Number:2007-000628-41
    Sponsor's Protocol Code Number:D9615C00021
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-27
    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
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedBelgium - FPS Health-DGM
    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 Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountryBelgium
    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 organisation
    B.5.2Functional name of contact point
    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 for 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 Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    This is a Phase I pharmacokinetic study of repeated doses of esomeprazole given as a once daily injection over 3 minutes in paediatric patients 0 to 17 years old, inclusive. This formulation has been developed as an alternative to the oral esomeprazole formulation in order to treat patients when oral intake is not possible.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018203
    E.1.2Term GERD
    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 (AUCĪ„) on Day 4 of the study based on population PK modelling.
    E.2.2Secondary objectives of the trial
    1. Evaluate the PK of repeated doses of esomeprazole given as a once daily injection over 3 minutes in paediatric patients 0 to 17 years old, inclusive by assessment of the maximum plasma concentration, total plasma clearance and steady state volume of distribution on Day 4 of the study based on population PK modeling; evaluate the PK of the main metabolites of esomeprazole (sulphone metabolite and 5-hydroxy metabolite) after repeated doses of esomeprazole by assessment of Css, max, AUCt, clearance scaled by fraction metabolized and steady state volume of distribution scaled and evaluate the safety of esomeprazole given once daily for 4 days as an injection over 3 minutes in paediatric patients 0 to 17 years old, inclusive, by assessment of adverse events, laboratory variables, blood presure, heart rate, respiration rate, body temperature and electrocardiogram.
    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)
    None
    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 Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months26
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months26
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.3Newborns (0-27 days) Yes
    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) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-04-27. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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.4.1In the member state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 55
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2009-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
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