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    Summary
    EudraCT Number:2009-013737-24
    Sponsor's Protocol Code Number:IB451/05PI
    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:2009-09-17
    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 number2009-013737-24
    A.3Full title of the trial
    TRATAMIENTO MULTIDISCIPLINARIO DE LA OBESIDAD MÓRBIDA: MEDICAMENTOS, TERAPIA DE COMPORTAMIENTO, APOYO NUTRICIONAL Y ACTIVIDAD FÍSICA. ESTDIO TRAMOMTANA
    A.3.2Name or abbreviated title of the trial where available
    TRAMOMTANA
    A.4.1Sponsor's protocol code numberIB451/05PI
    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 SponsorHOSPITAL UNIVERSITARIO SON DURETA. UNIDAD DE INVESTIGACIÓN
    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 nameReductil
    D.3.2Product code 63823
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    terapia complementaria dentro de un programa integral para
    el control del peso en:
    - Pacientes con obesidad, cuyo IMC (Índice de Masa Corporal) es 30 kg/m2 o superior
    - Pacientes con sobrepeso, cuyo IMC es 27 kg/m2 o superior, que presenten otros factores
    de riesgo asociados a la obesidad como diabetes tipo 2 o dislipidemia.
    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
    Evaluar en pacientes con obesidad mórbida el impacto de un programa de pérdida de peso intensivo, multidisplinario, no quirúrgico, que incluye: terapia de comportamiento, actividad física, consejo dietético y farmacoterapia en comparación a un grupo médico que seguirá el tratamiento estándar actual y a un grupo quirúrgico constituido por pacientes con obesidad mórbida que se hayan sometido a cirugía bariátrica como tratamiento para su obesidad.
    E.2.2Secondary objectives of the trial
    Evaluar el impacto de este tratamiento multidisciplinar sobre el control de la diabetes mellitus tipo 2 y sus complicaciones, el riesgo de enfermedad cardiovascular, la calidad de vida, el número de hospitalizaciones y los costes y rentabilidad asociados a la intervención propuesta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Personas que padezcan obesidad mórbida (IMC > 40 Kg/m2) con DMT2, otras co-morbilidades, riesgo moderado para la ocurrencia de enfermedad cardiovascular, que están dispuestos a seguir el protocolo descrito como intervención, y que aceptan el ser randomizados para participar en el estudio.
    E.4Principal exclusion criteria
    • Incapaz o poco dispuesto a firmar el consentimiento o a participar en las sesiones de grupo o consultas.
    • Diagnosis actual de esquizofrenia, u otros tipos de psicosis bipolar.
    • Hospitalización para tratamiento de la depresión durante los últimos seis meses.
    • Historia de abuso de alcohol o drogas estupefacientes en los últimos doce meses.
    • Historia de pérdida de peso superior a los 10 Kg. en últimos tres meses.
    • Uso actual de medicamentos para la pérdida peso.
    • Incapacidad de caminar 50 metros.
    • Historia de la cirugía bariatrica, o de resecciónes intestinales.
    • Tratamiento crónico con corticoesteroides.
    • Peso mayor de 160 kg debido a las limitaciones de peso del equipo que tenemos disponible.
    • Embarazo.
    • Cáncer que haya requerido tratamiento en los últimos cinco años, a excepción de los cánceres de piel (no-melanoma) o cánceres que se muestran claramente curado en opinión del investigador.
    • VIH Positivo.
    • Tuberculosis activa.
    • Enfermedad cardiovascular (Infarto de miocardio o procedimiento cardiaco en los últimos tres meses.
    • Cualquier anormalidad durante la prueba de esfuerzo.
    • Enfermedad renal: creatinina en suero superior al 1.4 mg/dl (mujeres) o 1.5 mg/dl (hombres), o actualmente en tratamiento con diálisis.
    • Enfermedad pulmonar obstructiva crónica.
    • Hepatitis crónica B o C o cirrosis.
    • Enfermedad inflamatoria del intestino.
    • Síndrome de Cushing.
    • Acromegalia.
    • Amputación de miembros más bajos como resultado de causas no-traumáticas.
    • Cualquier trasplante de órganos importante (no incluya los trasplantes de la córnea o del pelo).
    E.5 End points
    E.5.1Primary end point(s)
    Impacto sobre perdida de peso. Este estudio evaluará de forma mensual el impacto de este programa médico sobre el peso corporal (índice de masa corporal: IMC) y la circunferencia abdominal.
    Control de diabetes mellitus tipo 2 (DMT2) y complicaciones. Se utilizarán medidas de control glucémico (HbA1c y glucemias), función renal (albuminuria), dosis y número de medicamentos antiglucemiantes, con intención de caracterizar el impacto de este programa sobre el control metabólico y la evolución de las complicaciones de la diabetes, en estos sujetos con obesidad mórbida.
    Riesgo de enfermedad cardiovascular. Se realizarán medidas de tensión arterial, así como se evaluará la incidencia y control de la hipertensión, incidencia de hiperlipidemia, niveles de lípidos, y detección de marcadores inflamatorios.
    Calidad de vida y resultados psicológicos. Se examinará el impacto relativo de la intervención terapéutica en la calidad de vida y en los aspectos psicológicos del sujeto, incluyendo el funcionamiento físico, social y la detección de depresión. Hospitalizaciones. Se caracterizará el impacto relativo de la intervención del programa en el número de hospitalizaciones requeridas por los participantes.
    Costes y rentabilidad. El TRAMOMTANA estimará el coste y rentabilidad asociados a esta intervención medica continuada, comparado al tratamiento quirúrgico.

    Por ultimo también evaluaremos el impacto de esta intervención sobre la incidencia de: i) muerte (cualquier causa), ii) infarto del miocardio, iii) bypass coronario iv) angioplastia percutánea coronaria, v) hospitalización por enfermedad congestiva cardiaca vi) endarterectomia carótida, o vii) enfermedad vascular periférica (bypass o angioplastia) sobre el período previsto de 2 años.
    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 No
    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 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) 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Consultas médicas habituales y cirugía bariátrica
    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 Information not present in EudraCT
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state60
    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 Decision2009-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-25
    P. End of Trial
    P.End of Trial StatusOngoing
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