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    Summary
    EudraCT Number:2007-003673-21
    Sponsor's Protocol Code Number:CT-2006-5
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-10-29
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2007-003673-21
    A.3Full title of the trial
    ENSAYO CLÍNICO DOBLE CIEGO, CONTROLADO, ALEATORIZADO, EN FASE IV, COMPARATIVO DEL EFECTO DE LA COMBINACIÓN DE SRO Y RACECADOTRILO VERSUS SRO Y PLACEBO EN NIÑOS CON DIARREA AGUDA

    Double blind clinical trial, controlled, randomized, phase IV, comparative of the effect of oral serum and racecadotril versus oral serum and placebo in children with acute diarrhoea.
    A.3.2Name or abbreviated title of the trial where available
    Hydratior
    A.4.1Sponsor's protocol code numberCT-2006-5
    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 SponsorRamón Tormo Carnicé
    B.1.3.4CountrySpain
    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 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 Information not present in EudraCT
    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 nameRacecadotrilo
    D.3.2Product code Racecadotrilo
    D.3.4Pharmaceutical form Granules for oral suspension
    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 INNRacecadotrilo
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number4,5 mg/kg
    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 placeboGranules for oral suspension
    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
    Diarrea Aguda (Acute Diarrhorea).
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia del tratamiento con SRO + racecadotrilo y SRO + placebo, en niños con diarrea agudan de más de tres meses de edad y hasta 13 kg de peso .

    Compare the treatment efficacy of SRO + racecadotril and SRO + placebo in children of more than three months and up to 13 Kg of weight.
    E.2.2Secondary objectives of the trial
    1. Descripción de la etiología de la diarrea en ambos grupos de tratamiento.
    2. Determinar la seguridad del tratamiento administrado.
    3. Determinar el umbral de reducción de concentración de agua en heces clínicamente significativo en cuanto a sintomatología.
    4. Valorar la utilización de racecadotrilo en niños menores de 2 años.

    1. Describe the diarrhoea ethiology in both treatment groups.
    2. To determine the administered treatment security.
    3. To determine the threshold of water concentration in faeces clinically significant related to the symptoms.
    4. To evaluate the use of racecadotril in children younger than 2 years.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Pacientes en los cuales los progenitores o los representantes legales hayan firmado el consentimiento una vez informado por escrito u oralmente ante testigos, de acuerdo con los requisitos reglamentarios vigentes, antes de iniciar los procedimientos específicos del protocolo.
    2) Pacientes con diarrea aguda - deposiciones incrementadas en frecuencia (más de 2-3 deposiciones/día) con alteración en la consistencia - con indicación de ingreso y con 24 (+12) horas de evolución, o bien pacientes con diarrea aguda ya ingresados en el centro.
    3) Niños varones de un mínimo de 3 meses de edad y hasta 13 kg de peso indicados para iniciar una terapia antidiarreica.
    4) La previsión de duración de la estancia en el centro hospitalario debe ser de un mínimo de 48h.
    1) Patients whose parents or legal representative have signed the informed consent once the parents/legal representative have been informed in writing or oral with witness following the legal requirements before the beginning the protocol specifications.
    2) Patients with acute diarrhoea -increased depositions in frecuency (more than 2-3 depositions/day) with altered consistency- with the indication of admited to hospital and with 24 (+12) hours of evolution, or patients with acute diarrhoea being in a hospital.
    3)Male children with a minimum of 3 months of age to 13 Kg of weight that have to begin with a antidiarreic therapy.
    4) The predicted minimum stay in the hospital has to be 48 h.
    E.4Principal exclusion criteria
    1) Pacientes que hayan iniciado algún tratamiento farmacológico antidiarreico previo.
    2) Pacientes que presenten hipersensibilidad al principio activo o a alguno de los excipientes o presenten intolerancia a la fructosa, el síndrome de malabsorción de la glucosa o deficiencia de sacarasa-isomaltasa (véase Contraindicaciones en Ficha Técnica, anexo 1).
    3) Pacientes con tratamiento antibiótico.
    4) Tratamiento antidiarreico con probioticos.
    5) Pacientes con rehidratación por vía parenteral.


    1)Patients with a previous pharmacologic antidiarreic treatment.
    2)Patients with hipersensinbility to the active drug or some of the excipients or with intolerance to fructose or patientes with glucose malabsorption syndrome or deficiency sacarase-isomaltase.
    3)Patients with antibiotic treatment.
    4)Patients with antidiarreic treatment with probiotic drugs.
    5)Patients with intravenous rehidratation.
    E.5 End points
    E.5.1Primary end point(s)
    Variación de la concentración de agua en las heces, desde el momento basal hasta las 48h, determinada mediante espectrofotometría de infrarrojo próximo.


    Change in water concentration in faeces from basal to 48 h determined using near infra-red spectrometry.
    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) 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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    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 Information not present in EudraCT
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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.1.1.1In 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.1.1.5Children (2-11years) Yes
    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 No
    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 older than 3 months to 13 kg. of weight.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state198
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 198
    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 Decision2007-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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