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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2007-005019-25
    Sponsor's Protocol Code Number:PLAN-EC-PEDIA-01
    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:2008-03-05
    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 number2007-005019-25
    A.3Full title of the trial
    Ensayo clínico, multicéntrico, aleatorizado, con grupos paralelos, controlado con placebo y doble ciego, para analizar el efecto del tratamiento con cutículas de semillas de Plantago Ovata sobre la incidencia de remisión de síndrome metabólico en niños y adolescentes de 10 a 16 años de edad.
    A.4.1Sponsor's protocol code numberPLAN-EC-PEDIA-01
    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 SponsorMADAUS, S.A.
    B.1.3.4CountrySpain
    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 Plantaben sobres monodosis
    D.2.1.1.2Name of the Marketing Authorisation holderMADAUS. S.A.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Effervescent powder
    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 INNCutículas de semillas de Plantago ovata
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 Yes
    D.3.11.13.1Other medicinal product typeFibra dietética
    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 placeboEffervescent powder
    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
    Niños o niñas de 10 a 16 años de edad con criterios diagnósticos de síndrome metabólico según criterios de la Internacional Diabetes Federation
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052066
    E.1.2Term Metabolic syndrome
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar el efecto de la administración de un tratamiento con cutículas de semillas de Plantago Ovata en comparación a placebo sobre la incidencia de remisión de síndrome metabólico según los criterios de la IDF en niños de 10 a 16 años de edad.
    E.2.2Secondary objectives of the trial
    1. La variación en el número de criterios definitorios de síndrome metabólico presentes según las definiciones de la IDF.

    2. Los cambios en el peso, el perímetro de la cintura, y diferentes factores de riesgo cardiovascular: tensión arterial sistólica y diastólica, concentraciones plasmáticas de glucemia, colesterol total, c-LDL, c-HDL, triglicéridos, relación c-LDL/HDL y CT/c-LDL.

    3. Los cambios en el tamaño de las partículas LDL.

    4. Los cambios en la resistencia a la insulina determinada mediante el método HOMA.

    5. Los cambios en las concentraciones plasmáticas de PCR, amiloide sérico, adiponectina, IL-6 e IL-10.

    6. El grado de cumplimiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Niños o niñas de 10 a 16 años de edad con criterios diagnósticos de síndrome metabólico según criterios de la Internacional Diabetes Federation que se exponen a continuación:

    - Circunferencia de cintura ³ percentil 90 de la población según la edad, de acuerdo a las tablas de niños europeos (McCarthy et al Eur J Clin Nutr. 2001 Oct;55(10):902-7) (ver anexo 4).
    - Presencia de 2 o más de los siguientes factores:
    § Cifras tensionales altas: presión sistólica ³ 130 mmHg o diastólica ³ 85 mmHg o hipertensión tratada.
    § Triglicéridos ³ 1,7 mmol/l o hipertrigliceridemia tratada.
    § Cifras de colesterol HDL < 1,03 mmol/l o toma de medicamentos para aumentar el colesterol HDL.
    § Glucemia >5.6 mmol/l (prueba de tolerancia oral a la glucosa (PTOG) recomendado) o diabetes mellitus tipo 2 conocida tratada o no tratada
    2. Altamente motivados y que deseen firmar ellos y sus respectivos tutores el consentimiento informado a participar en el estudio.
    E.4Principal exclusion criteria
    1. Pérdida de > 3 kg en los últimos 2 meses
    2. Circunferencia de la cintura diez centímetros por encima del percentil 90 de la población según la edad del adolescente.
    3. Toma de fibra, suplementos de avena o fitosteroles en los últimos 2 meses
    4. Hipertrigliceridemia > 4,5 mmol/l
    5. TAS > 145 mmHg o TAD > 95 en el momento de entrar en el estudio
    6. Hemoglobina glicosilada superior a 7% en el momento de entrar en el estudio.
    7. Hipercolesterolemia familiar no poligénica.
    8. Enfermedad endocrinológica distinta de la Diabetes tipo 2.
    9. Enfermedad infecciosa activa
    10. Antecedentes de cáncer
    11. Toma de medicaciones en estudio en los últimos 2 meses
    12. Modificación de la pauta de antihipertensivos, hipolipemiantes o antidiabéticos en los últimos 2 meses
    13. Enfermedad inflamatoria crónica o toma de antiinflamatorios de manera continuada.
    14. Toma de corticoides orales o vía parenteral de manera continuada.
    15. Modificación de la pauta de tratamiento anticonceptivo.
    16. Enfermedad grave
    17. Dificultad en acudir a consultas o previsión de dificultades en el seguimiento
    18. Alergia al Plantago ovata
    19. Historia de enfermedad gastrointestinal que pueda alterar la absorción de nutrientes
    20. Obstrucción intestinal o pseudo obstrucción
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de remisión de síndrome metabólico según los criterios de la IDF.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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 concerned8
    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 Information not present in EudraCT
    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 months
    E.8.9.1In the Member State concerned days
    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) No
    F.1.1.5Children (2-11years) No
    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 Information not present in EudraCT
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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 Decision2008-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-15
    P. End of Trial
    P.End of Trial StatusOngoing
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