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    The EU Clinical Trials Register currently displays   35503   clinical trials with a EudraCT protocol, of which   5838   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-002001-31
    Sponsor's Protocol Code Number:D9614C00004
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2006-002001-31
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of esomeprazole once daily for the treatment of gastroesophageal reflux disease (GERD) in neonatal patients, including premature and up to 1 month corrected age
    A.4.1Sponsor's protocol code numberD9614C00004
    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.1.3.4CountrySweden
    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 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 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 (oral solution)
    D.3.2Product code NA
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral 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.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral solution
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    This prospective study will evaluate the efficacy and safety of esomeprazole for the treatment of GERD in neonatal patients.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10017885
    E.1.2Term Gastrooesophageal reflux disease
    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 this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms of GERD as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    · to assess the difference between esomeprazole and placebo in the treatment of symptomatic reflux episodes of GERD.
    · to assess the difference between esomeprazole and placebo in the treatment of other GERD-related signs and symptoms via video, pH/impedance, and cardiorespiratory monitoring
    · to assess the efficacy of esomeprazole, compared to placebo, in reducing the number of (a) all types of reflux episodes (acid or non-acid) and (b) acidic reflux episodes, defined as pH < 4, via pH/impedance monitoring
    · to assess the safety and tolerability of esomeprazole compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study, patients must fulfil all of the following criteria:
    1. Patients’ parent/guardian must provide written informed consent prior to the execution of any study-related procedures.
    2. Patients must be full term or have gestational age ³ 28 to 44 weeks (calculated from last menstruations or ultrasound). Patients that are less than 28 weeks gestation may be considered for the study if they fulfill all other criteria, in particular criteria # 5.
    3. Patients must be an inpatient in the Neonatal Intensive Care Unit (NICU), special care nursery, or equivalent hospital ward at the point of study entry and will be expected to remain an inpatient for the treatment period of the study. If the patient is discharged prior to completion of the treatment phase, parents may be given the option of having at home visits for study drug administration to their baby at the discretion of the investigator. These patients will need to be readmitted to the hospital or, if applicable, brought back to a day clinic for final study day procedures. A treatment period of less than 10 days (minimum 7 days) may be allowed, on a case-by-case basis, with prior approval from the sponsor, provided the patient is considered to be medically stable and considered for discharge from the hospital.
    4. Patients must be suspected of having the following clinical findings: any two (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second feed or at least twice every eight hours so as to be reproducible on video. Any symptom(s) of GERD that are present for at least 5 days or increasing in frequency or severity over 3 days will make a patient eligible. At least 2 of the occurrences of the above should be reproducible during the 8 hour video. Patients with clinically suspected GERD, based on parental reports or nursing observations may, at the discretion of the investigator, be eligible for enrollment if they fulfill the above criterion regarding the presence of the clinical findings.
    5. Patient’s size and medical condition must allow for performance of all study related procedures and administration of investigational product as judged by the investigator.
    6. Patients must, ideally, be on a stable mode of feeding or with minimal variations in feeding as judged by the investigator for at least 2 days prior to randomization. If a patient needs a change in feeds for a medical reason, the sponsor must be notified to determine if the patient remains eligible for the study or should be withdrawn.
    E.4Principal exclusion criteria
    Any of the following is regarded as a criterion for exclusion from the study:
    1. Patients who exhibit total resolution of all signs and symptoms of GERD during the initial 8 hour video assessment.
    2. Use of any pharmacological antireflux therapy (other than study drug) within 72 hours prior to any pH/impedance monitoring. Antacids may be used if it is required during the study as “rescue therapy”, but are not allowed to be taken ± 1 hour to administration of the investigational product and also not 4 hours before and throughout the pH-impedance monitoring at baseline and the final study day.
    3. Patients with a history or a current need for resectional or reconstructive surgery of the gastrointestinal tract (esophagus, stomach, duodenum or jejunum).
    4. Patients with any condition that may require surgery during the course of the study. Once a patient is enrolled, if a medical condition develops or a pre-existing condition worsens necessitating surgery, then the patient will be allowed to remain in the study provided that there are no additional safety concerns.
    5. Patients who must remain on any of the following concomitant medications during the course of the study: bismuth-containing products, barbiturates, anti-convulsants, warfarin, narcotics, antineoplastic agents, H2 receptor antagonists, sucralfate, anti-emetics, pro-motility drugs (eg, cisapride, metoclopramide, macrolide antibiotics such as erythromycin). Use of topical erythromycin is permissible. However, occasional use of restricted medications, when medically indicated after enrollment, is permissible at the discretion of the investigator. If any restricted medication is used, the name of the medication and the reason for taking it should be recorded on the eCRF.
    6. Patients with the following diseases/conditions: active gastrointestinal bleed, allergic gastroenteropathies, eosinophilic gastroenteritis, bleeding disorders, active seizure disorder, on-going treatment for seizure disorder, acute pancreatitis or meningitis.
    7. Patients with acute respiratory distress within 24 hours prior to enrollment or the likelihood of acute or worsening respiratory distress during the course of the study. A patient may be reconsidered for enrollment once stabilized. Patients with a chronic lung condition, suspected of having GERD as a contributor and who are candidates for acid-suppression therapy are eligible for the study.
    8. Patients who are febrile per NICU standards on the day of randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Primary: change from baseline in the number of occurrences of symptoms of GERD, as observed from video recording, and GERD-related signs detected from cardiorespiratory monitoring
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Information not present in EudraCT
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months27
    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) No
    F.1.1.5Children (2-11years) No
    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 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
    Neonatal patients, including premature and up to 1 month corrected age
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    N/A
    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 Decision2007-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-04-14
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