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    The EU Clinical Trials Register currently displays   42782   clinical trials with a EudraCT protocol, of which   7047   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-002004-92
    Sponsor's Protocol Code Number:OralRehyd
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-10
    Trial 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 ConcernedAustria - BASG
    A.2EudraCT number2015-002004-92
    A.3Full title of the trial
    Acute gastroenteritis in paediatrics :
    Comparison of two oral rehydration preparations - A randomized pilot study
    Akute Gastroenteritis in der Pädiatrie:
    Vergleich von zwei oralen Rehydrations-Präparaten - Eine randomisierte Pilotstudie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Gastric flu study
    Magen-Darm Grippe Studie
    A.3.2Name or abbreviated title of the trial where available
    OralRehyd
    A.4.1Sponsor's protocol code numberOralRehyd
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMedizinische Universität Graz, Klinische Abteilung für allgemeine Pädiatrie
    B.1.3.4CountryAustria
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMedizinische Universität Graz
    B.4.2CountryAustria
    B.4.1Name of organisation providing supportECA-Medical
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMedical University of Graz
    B.5.2Functional name of contact pointDepartment of general paediatrics
    B.5.3 Address:
    B.5.3.1Street AddressAuenbruggerplatz 34/ II
    B.5.3.2Town/ cityGraz
    B.5.3.3Post code8036
    B.5.3.4CountryAustria
    B.5.4Telephone number+433163853008
    B.5.6E-mailharald.haidl@medunigraz.at
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Normolyt
    D.2.1.1.2Name of the Marketing Authorisation holderGebro Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 Powder for oral solution
    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.3.8INN - Proposed INNglucose
    D.3.9.1CAS number 50-99-7
    D.3.9.3Other descriptive nameGLUCOSE, ANHYDROUS
    D.3.9.4EV Substance CodeSUB11988MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium chloride
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12581MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number350
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsodium citrate
    D.3.9.3Other descriptive nameSODIUM CITRATE
    D.3.9.4EV Substance CodeSUB12582MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number590
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpotassium chloride
    D.3.9.3Other descriptive namePOTASSIUM CHLORIDE
    D.3.9.4EV Substance CodeSUB12559MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number300
    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
    acute gastroenteritis
    Akute Gastroenteritis
    E.1.1.1Medical condition in easily understood language
    gastric flu
    Magen-Darm Grippe
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10017784
    E.1.2Term Gastric flu
    E.1.2System Organ Class 100000004862
    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 clinical trial is to investigate whether Lytomed® finds greater acceptance among children of 1-13 years compared to Normolyt®.
    Primäres Ziel dieser klinischen Prüfung ist, zu untersuchen, ob Lytomed® im Vergleich zu Normolyt® eine höhere Akzeptanz bei Kindern von 1-13 Jahren findet.
    E.2.2Secondary objectives of the trial
    Alterations of base excess
    Change of the duration of the hospitalisation
    Alterations of body weight
    Change of compliance
    Veränderungen des Base Excess
    Veränderungen der stationären Aufenthaltsdauer
    Veränderungen des Körpergewichts
    Veränderung der Compliance
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Hospitalisation due to acute gastroenteritis
    • Written informed consent of the parents of the participating child and the child's informed consent
    • Age: 1-13 years
    • necessity of receiving an oral rehydration preparation
    • Stationärer Aufenthalt aufgrund akuter Gastroenteritis
    • Schriftliche Einverständniserklärung der Eltern des teilnehmenden Kindes sowie Einwilligung des Kindes nach erfolgter Aufklärung
    • Alter: 1-13 Jahren
    • Notwendigkeit der Gabe eines oralen Rehydrations-Präparates
    E.4Principal exclusion criteria
    • Parenteral rehydration
    • A history of hypersensitivity to any of the active substances or ingredients used
    • Diabetes mellitus
    • kidney diseases
    • reduction in blood acidity
    • persistent vomiting
    • disturbances of consciousness and unconsciousness
    • Metabolic alkalosis
    • anuria
    • monosaccharide malabsorption
    • Shock
    •Pregnancy
    • Parenterale Rehydration
    • Anamnestisch bekannte Überempfindlichkeit gegenüber einem der eingesetzten Wirk- bzw. Inhaltsstoffen
    • Diabetes mellitus
    • Nierenerkrankungen
    • Verminderung des Blutsäuregrades
    • Unstillbares Erbrechen
    • Bewusstseinsstörungen und Bewusstlosigkeit
    • Metabolische Alkalose
    • Anurie
    • Monosaccharid-Malabsorption
    • Schock
    • Schwangerschaft
    E.5 End points
    E.5.1Primary end point(s)
    Acceptance of the oral Rehydration solution.
    Akzeptanz der oralen Rehydrationslösung.
    E.5.1.1Timepoint(s) of evaluation of this end point
    0-maximum 72 hours after first admission
    0-maximal 72 Stunden nach Erstgabe
    E.5.2Secondary end point(s)
    base excess
    duration of the hospitalisation
    body weight
    compliance
    Base Excess
    stationäre Aufenthaltsdauer
    Körpergewicht
    Compliance
    E.5.2.1Timepoint(s) of evaluation of this end point
    0-maximum 72 hours after first admission
    0-maximal 72 Stunden nach Erstgabe
    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 Yes
    E.6.4Safety No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    Elektrolytlösung mit Glucose
    Glucose-electrolytic solution
    E.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLP
    Letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    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: 60
    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: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 35
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    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
    Children under age of 14 years
    Kinder mit einem Alter unter 14 Jahren
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    children under the age of 14 years
    Kinder mit einem Alter unter 14 Jahren
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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)
    none
    keine
    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 Decision2015-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
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