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    Summary
    EudraCT Number:2015-002923-24
    Sponsor's Protocol Code Number:R033812GTS3001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-03-18
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2015-002923-24
    A.3Full title of the trial
    A Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group, Prospective Study to Evaluate the Safety and Efficacy of Domperidone in 6-month-old to 12-year-old Pediatric Subjects With Nausea and Vomiting Due to Acute Gastroenteritis
    Estudio prospectivo, multicéntrico, doble ciego, aleatorizado, controlado con placebo y con grupos paralelos para evaluar la seguridad y eficacia de domperidona en sujetos pediátricos de 6 meses a 12 años de edad con náuseas y vómitos debido a gastroenteritis aguda
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Safety and Efficacy of Domperidone in Pediatric Participants With Nausea and Vomiting Due to Acute Gastroenteritis
    Estudio para evaluar la seguridad y eficacia de Domperidona en participantes pediátricos con nauseas y vómitos debido a gastroenteritis aguda.
    A.4.1Sponsor's protocol code numberR033812GTS3001
    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 SponsorJanssen-Cilag International NV
    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 supportJanssen-Cilag International NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQuintiles S.L.
    B.5.2Functional name of contact pointRSU Departament
    B.5.3 Address:
    B.5.3.1Street AddressVia de los Poblados 3
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number+34938833443
    B.5.5Fax number+34938833443
    B.5.6E-maillaulet@eapvic.org
    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 Motilium
    D.2.1.1.2Name of the Marketing Authorisation holderJohnson & Johnson Consumer NV/SA
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Oral suspension
    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 INNDOMPERIDONE
    D.3.9.1CAS number 99497-03-7
    D.3.9.4EV Substance CodeSUB06361MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOral 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
    Nausea and Vomiting Due to Acute Gastroenteritis
    Nauseas y vómitos debido a gastroenteritis aguda
    E.1.1.1Medical condition in easily understood language
    Nausea and vomiting due to sudden inflammation of the stomach and intestines.
    Nauseas y vómitos debido a inflamación repentina del estómago y los intestinos
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10066762
    E.1.2Term Acute gastroenteritis
    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 study is to demonstrate that domperidone suspension (1 mg/mL) plus ORT is more effective than placebo plus ORT at reducing the symptoms of vomiting associated with AG within the first 48 hours of treatment administration in pediatric subjects, 6 months to 12 years old, with AG and mild-to-moderate dehydration.
    Overall safety will be assessed.
    El objetivo principal de este estudio es demostrar que la suspensión de domperidona (1 mg/ml) más el tratamiento de rehidratación oral (TRO) es más eficaz que el placebo más TRO a la hora de reducir los vómitos asociados con la GA en las primeras 48 horas de administración del tratamiento en sujetos pediátricos, de 6 meses a 12 años de edad, con GA y deshidratación leve o moderada.
    Se evaluará la seguridad global.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the treatment groups with regard to improvements in the frequency of nausea episodes (in children aged 4 years or older), hydration status, weight change, proportion of subjects who visit an emergency department or require hospital treatment, within 0 to 24-hour, >24- to 48-hour, and >48-hour to 7-day periods after the first treatment administration.
    Los objetivos secundarios son comparar los grupos de tratamiento con respecto a las mejoras en la frecuencia de los episodios de náuseas (en niños de 4 años o más), el estado de hidratación, el cambio en el peso y la proporción de sujetos que acuden a urgencias o que requieren tratamiento hospitalario, en los periodos de 0 a 24 horas, >24 a 48 horas y >48 horas a 7 días después de la primera administración del tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The participant presents with at least 3 episodes of nonbilious, non-bloody vomiting within the 24 hours prior to visiting the physician?s office.
    - The participant has at least 2 signs and symptoms other than vomiting consistent with acute gastroenteritis (AG) (example, fever, nausea, diarrhea, abdominal pain, bloating, or discomfort) within 3 hours prior to visiting the physician?s office
    - The participant has mild-to-moderate dehydration
    - The participant had at least 1 episode of non-bloody diarrhea within the 24 hours prior to the visiting the physician?s office
    El participante presenta al menos 3 episodios de vómitos no biliosos ni sanguinolentos en las 24 horas previas a la consulta con el médico.
    Los sujetos se presentan con al menos 3 episodios de vómito no bilioso ni sanguinolento en las 24 horas previas a acudir a la consulta del médico. Los sujetos tiene al menos dos signos y síntomas, aparte de vómitos, que sugieren GA (es decir, fiebre, náuseas, diarrea, dolor, distensión o molestias abdominales) en las 3 horas previas a acudir a la consulta del médico
    El participante presenta al menos 1 episodio de diarrea no sanguinolenta en las 24 horas previas a la consulta con el médico.
    El participante presenta deshidratación leve o moderada.
    E.4Principal exclusion criteria
    - The participant has severe dehydration or severe malnutrition
    - The participant who has vomiting and clinical symptoms for longer than 72 hours prior to the baseline physician?s office visit
    - The participant needs intravenous (IV) fluid replacement
    - The participant has chronic severe diarrhea, a previous history of Helicobacter pylori infection or received treatment for H. pylori-induced gastritis, active peptic ulcer, celiac disease, Crohn?s disease, ulcerative colitis, eosinophilic esophagitis, malabsorption, short bowel syndrome, post-viral gastroparesis, cyclic vomiting syndrome, or previous gastrointestinal surgery
    - The participant has upper respiratory symptoms such as cough, congestion, otitis media or pharyngitis
    - El participante presenta deshidratación severa o malnutrición.
    - El participante tiene vómitos y síntomas clínicos durante más de 72 horas antes de la visita inicial a la consulta del médico
    El sujeto necesita reposición de líquidos i.v.
    El sujeto tiene diarrea intensa crónica, antecedentes previos de infección por Helicobacter pylori o ha recibido tratamiento para la gastritis inducida por H. pylori, úlcera péptica activa, enfermedad celíaca, enfermedad de Crohn, colitis ulcerosa, esofagitis eosinofílica, malabsorción, síndrome del intestino corto, gastroparesia posvírica, síndrome de vómitos cíclicos o cirugía gastrointestinal previa.
    El sujeto tiene síntomas respiratorios de las vías altas, como tos, congestión, otitis media o faringitis.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of Participants With No Vomiting Episode Within the First 48 Hours of the First Treatment Administration.
    Porcentaje de participantes sin episodios de vómitos durante las primeras 48 horas desde la primera administración del tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 Hours
    48 horas
    E.5.2Secondary end point(s)
    a) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the First 48 Hours of the First Treatment Administration
    b) Number of Vomiting Episodes for Participants Within the 0 to 24 Hour, Greater Than (>) 24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    c) Number of Episodes of Nausea for Participants 4 Years of Age or Older Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    d) Percentage of Participants who Have No Episode of Vomiting Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    e) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    f) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 0 to 24 Hour, >24 to 48 Hour, and >48 Hour to 7 Day Periods After the First Treatment Administration
    g) Percentage of Participants 4 Years of Age or Older Who Have No Episode of Nausea Within the 7 Day Treatment Period After the First Treatment Administration
    h) Percentage of Participants Taking a Rescue Medication Within the 7 Day Treatment Period
    i) Percentage of Participants Stopping Study Medication Early Due to Vomiting-Free for 24 Hours Within the 7 Day Treatment Period
    j) Time to Last Study Medication Within the 7 Day Treatment Period
    k) Percentage of Participants Referred to an Emergency Room/Hospital for Treatment Within the 7 Day Treatment Period
    l) Time-to-Last Vomiting Within the 7 Day Period After the First Treatment Administration
    m) Change From Baseline in Hydration Score at Day 2
    n) Change From Baseline in Weight at Day 2
    o) Percentage of Participants With Diarrhea Within 0 to 24 Hour, >24 to 48 Hour, >48 Hour to 7 Day, and 0 Hour to 7 Day Periods After the First Successful Treatment Administration
    ? El principal criterio de valoración secundario es el porcentaje de sujetos de 4 años de edad o más que no presentan episodios de náuseas en las primeras 48 horas después de la primera administración del tratamiento.
    ? El número de episodios de vómitos de los sujetos en los periodos de 0 a 24 horas, >24 a <48 horas y >48 horas a 7 días después de la primera administración del tratamiento.
    ? El número de episodios de náuseas de los sujetos de 4 años o más en los periodos de 0 a 24 horas, >24 a <48 horas y >48 horas a 7 días después de la primera administración del tratamiento.
    ? El porcentaje de sujetos que no han tenido episodios de vómitos en los periodos de 0 a 24 horas, >24 a <48 horas y >48 horas a 7 días después de la primera administración del tratamiento.
    ? El porcentaje de sujetos de 4 años o más que no han tenido episodios de náuseas en los periodos de 0 a 24 horas, >24 a <48 horas y >48 horas a 7 días después de la primera administración del tratamiento.
    ? El porcentaje de sujetos que no han tenido episodios de vómitos en el periodo de tratamiento de 7 días después de la primera administración del tratamiento.
    ? El porcentaje de sujetos de 4 años o más que no han tenido episodios de náuseas en el periodo de tratamiento de 7 días después de la primera administración del tratamiento.
    ? El porcentaje de sujetos que toman medicación de rescate en el periodo de tratamiento de 7 días.
    ? El porcentaje de sujetos que dejan de forma prematura la medicación del estudio debido a la ausencia de vómitos durante 24 horas en el periodo de tratamiento de 7 días.
    ? El tiempo hasta la última medicación del estudio en el periodo de tratamiento de 7 días.
    ? El porcentaje de sujetos remitidos a urgencias o al hospital para su tratamiento en el periodo de tratamiento de 7 días.
    ? El tiempo hasta el último vómito en el periodo de 7 días después de la primera administración del tratamiento.
    ? El cambio en la puntuación de rehidratación desde el día 1 (inicio del estudio) al día 2 (<24 horas después del inicio del estudio).
    ? El cambio en el peso desde el día 1 (inicio del estudio) al día 2.
    ? El porcentaje de sujetos con diarrea en los periodos de 0 a 24 horas, >24 a 48 horas, >48 horas a 7 días y 0 horas a 7 días después de la primera administración con éxito del tratamient
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) 48 Hours
    b) - l) Day 7
    m) - n) Baseline and Day 2
    o) Day 7
    a) 48 horas
    b) -I) Día 7
    m) -n) Basal y Día 2
    o) Día 7
    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) 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.8.2.4Number of treatment arms in the trial2
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Russian Federation
    South Africa
    E.8.7Trial has a data monitoring committee Yes
    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
    The study is considered completed with the last study assessment for the last subject participating in the study.
    El estudio se considerará completado con la última evaluación del estudio del último sujeto participante en el estudio.
    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 months10
    E.8.9.1In the Member State concerned days2
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days2
    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: 480
    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: 150
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 280
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 50
    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
    Infants, toddlers and children aged 6 month to 11 years.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 480
    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.
    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 Decision2016-05-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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