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    The EU Clinical Trials Register currently displays   42330   clinical trials with a EudraCT protocol, of which   6971   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:2006-000567-28
    Sponsor's Protocol Code Number:TROTA-1
    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:2007-08-29
    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 number2006-000567-28
    A.3Full title of the trial
    Eficacia de tungstato sódico por vía oral a una dosis fija de 200 mg por día sobre la pérdida de peso en pacientes con obesidad grado I y grado II.
    A.3.2Name or abbreviated title of the trial where available
    Tratamiento Obesidad con Tungstato
    A.4.1Sponsor's protocol code numberTROTA-1
    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 SponsorFundació Clínic Recerca Biomédica
    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 No
    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 namesodium tungstate
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNtungstato sódico dihidratado
    D.3.9.1CAS number 10213-10-2
    D.3.9.3Other descriptive namesal sódica del ácido túngstico, dihidratado
    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 placeboFilm-coated tablet
    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
    Obesity
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10029883
    E.1.2Term Obesity
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo general del estudio es comparar el efecto sobre el peso corporal de la administración de tungstato sódico en comparación con placebo en un grupo de pacientes con obesidad grado I o grado II (índice de masa corporal 30-39,9 kg/m2) que siguen una dieta para mantenimiento del peso corporal.
    Objetivo principal: comparar la pérdida de peso tras 6 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    Comparar la proporción de pacientes que consiguen pérdidas de peso clínicamente significativas (>1,5 kg) en las 6 semanas de tratamiento.
    Comparar los cambios en los parámetros de síndrome metabólico, perfil lipídico (colesterol total, LDL, colesterol HDL, triglicicéridos, apolipoproteina B) e inflamatorios (proteína C reactiva) en ayunas tras 6 semanas de tratamiento
    Comparar los cambios en el consumo calórico, la sensación de hambre pre-ingesta, y la sensación de saciedad post-ingesta.
    Comparar los cambios en el gasto metabólico en reposo
    Comparar los cambios en la composición corporal
    Comparar los acontecimientos adversos y parámetros de seguridad
    Comparar los cambios en parámetros hormonales relacionados con el gasto energético y cambios en la expresión de proteínas relacionadas con el gasto energético en el adiposo subcutáneo abdominal
    Valorar la reversibilidad de los efectos de tungstato sódico al interrumpir el tratamiento.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sexo masculino
    Edad 18 a 65 años
    IMC 30 – 39,9 kg/m2
    Variación del peso corporal <3 kg en los 3 meses previos a la inclusión en el estudio
    Si presentan hipertensión arterial o dislipemia tratadas con fármacos estos deberán haberse mantenido a dosis estables en los 2 meses previos a la inclusión en el estudio
    Haber otorgado el consentimiento informado para la participación en el estudio
    E.4Principal exclusion criteria
    Sexo femenino
    Evidencia de causa secundaria de obesidad
    o Hipotiroidismo
    o Enfermedad de Cushing clínicamente aparente
    Antecedente de trastorno de la conducta alimentaria especificado tipo bulimia nerviosa o anorexia nerviosa
    Diabetes tipo 2
    o Glucemia en ayunas >126 mg/dl
    o Diagnóstico previo de diabetes tipo 2
    o Tratamiento con fármacos hipoglucemiantes
    Hipertensión arterial no controlada con o sin medicación
    o TAS >160 y/o TAD >95 mmHg
    Dislipemia no controlada con o sin medicación
    o Colesterol LDL >200 mg/dl
    o Triglicéridos > 250 mg/dl
    Historia de infarto agudo de miocardio o enfermedad cerebrovascular u otra patología vascular clínicamente significativa (angina inestable, arritmias, insuficiencia cardiaca (clase funcional III o IV de la New York Heart Association)
    Enfermedad psiquiátrica relevante
    o Depresión con historia de hospitalización, dos o más episodios de depresión mayor, historia de intento de suicidio
    Abuso de alcohol u otras drogas en los tres meses previos al estudio
    Enfermedad hepática o renal significativa
    o Creatinina plasmática superior a 1.4 mg/dl
    o ALT o AST x4 niveles de normalidad
    Otras enfermedades médicas graves a criterio del investigador como
    o Enfermedad pulmonar obstructiva grave
    o Patología maligna o antecedentes de ella en los 5 años previos al inicio del estudio
    Cirugía planificada durante el periodo de estudio
    Uso concomitante de otros tratamientos para pérdida de peso (ver anexo medicación concomitante)
    Uso concomitante de fármacos que puedan aumentar el peso corporal (ver anexo medicación concomitante)
    o Corticoides, antidepresivos, neurolépticos, anti-histamínicos no selectivos, anti-diabéticos orales
    Historia de tratamiento quirúrgico de la obesidad
    Voluntad de abandonar el hábito de fumar durante la duración del estudio
    Enfermedad aguda en las dos semanas previas al inicio del estudio
    Participación en otro ensayo clínico en los 3 meses previos
    Pérdida de peso superior a 1 kg en la fase inicial del estudio
    Sujetos que no sean capaces de entender la naturaleza, consecuencias del ensayo y los procedimientos que se les solicita seguir.

    E.5 End points
    E.5.1Primary end point(s)
    Cambio absoluto de peso (medido en kilogramos) al final del estudio respecto al peso en el momento de la aleatorización
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state44
    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 Decision2007-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
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