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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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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:2011-000106-22
    Sponsor's Protocol Code Number:GE012-098
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-11-18
    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 number2011-000106-22
    A.3Full title of the trial
    Estudio de fase 4 aleatorizado y a doble ciego para la comparación de la
    comodidad y seguridad del paciente entre Iodixanol 320 mg I/mL e Iopamidol 370
    mg I/mL en pacientes sometidos a arteriografía periférica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparar dos agentes de medios de contraste de rayos X sobre su seguridad y como los pacientes se sienten después de la inyección en la arteria.
    A.4.1Sponsor's protocol code numberGE012-098
    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 SponsorGE Healthcare Ltd. and its affiliates
    B.1.3.4CountryNorway
    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 supportGE HealthcareLtd. andits affiliates
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGE Healthcare Ltd. and its affiliates
    B.5.2Functional name of contact pointAnne Juelsrud
    B.5.3 Address:
    B.5.3.1Street AddressNycoveien 1-2
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0401
    B.5.3.4CountryNorway
    B.5.4Telephone number4723185424
    B.5.5Fax number4723186005
    B.5.6E-mailanne.juelsrud@ge.com
    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 VISIPAQUE 320 mg I/ml
    D.2.1.1.2Name of the Marketing Authorisation holderGE HEALTHCARE BIO-SCIENCES, S.A.U.
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIODIXANOL
    D.3.9.3Other descriptive nameIODIXANOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number320
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente de Contraste para Rayos - X
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country 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.3.1Product nameIopamidol 370 mg I/ml
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIOPAMIDOL
    D.3.9.1CAS number 62883-00-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number370
    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 Yes
    D.3.11.13.1Other medicinal product typeAgente de Contraste para Rayos-X
    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
    Pacientes que les estén realizando arteriografia periferica como procedimiento de rutina.
    Patients that are referred to undergo a peripheral arterigraphy as part of
    their routine clinical care.
    E.1.1.1Medical condition in easily understood language
    Investigación del paciente que ha sido referido para investigar su sistema circulatorio.
    Investigation of patient referred to have an investigation of their blood
    vessels
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10058049
    E.1.2Term Administration site pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10022086
    E.1.2Term Injection site pain
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10013082
    E.1.2Term Discomfort
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinar y comparar el perfil de comodidad global del paciente al administrarle medios de contraste isosmolares (MCIO), iodixanol 320 mg I/ml, y medios de contraste de baja osmolaridad (MCBO), iopamidol 370 mg I/ml, en pacientes sometidos a una TCIC del abdomen o la pelvis.
    La incomodidad del paciente se define como una sensación de frío, calor o dolor padecida por el paciente que se asocia temporalmente a la inyección/infusión del medio de contraste.
    E.2.2Secondary objectives of the trial
    ? Determinar y comparar los efectos de la incomodidad del paciente sobre el procedimiento de obtención de imágenes y la calidad general de estas últimas.
    ? Determinar y comparar el perfil de seguridad global en relación con la aparición de acontecimientos adversos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los sujetos podrán ser incluidos en el estudio si cumplen todos los criterios siguientes:
    (1) El sujeto es mayor de 18 años.
    (2) El sujeto ha sido remitido para que se le realice una TCIC del abdomen o la pelvis en el marco de su tratamiento médico habitual.
    (3) El sujeto ha entregado el consentimiento informado firmado y fechado.
    E.4Principal exclusion criteria
    Los sujetos deberán ser excluidos de este estudio si cumplen los criterios siguientes:
    (1) El sujeto tiene alergias conocidas al yodo o antecedentes de reacciones adversas a MC yodados.
    (2) Se le ha administrado al sujeto otra dosis del MC durante las 24 horas anteriores al periodo basal o está previsto que se le administre una dosis durante el periodo de seguimiento de 24 horas.
    (3) El sujeto es una mujer embarazada.
    (4) El sujeto está tomando metformina (p. ej., Glucophage®) pero no está dispuesto a interrumpir el tratamiento en el momento en que se realiza el procedimiento del estudio.
    Nota: No deberá tomarse metformina durante un mínimo de 24 horas anteriores a la realización de los procedimientos del estudio, su administración deberá suspenderse durante un mínimo de 48 horas posteriores al procedimiento y reanudarse solamente después de que se haya evaluado la función renal de los sujetos y se considere seguro reanudar el tratamiento con metformina.
    (5) El sujeto manifiesta tirotoxicosis o está en tratamiento con diálisis.
    (6) El sujeto ya ha participado en este estudio anteriormente.
    (7) El sujeto tiene una situación clínica inestable y su participación en el estudio podría comprometer su tratamiento o a juicio del investigador existe alguna razón que hace que la participación del sujeto en el estudio no sea adecuada.
    E.5 End points
    E.5.1Primary end point(s)
    Comparación de la intensidad máxima de incomodidad del paciente con iodixanol 320 mg I/ml o iopamidol 370 mg I/ml según opiniones de los sujetos a los 10 minutos de administrarles el contraste por vía intravenosa para la obtención de imágenes de TCIC del abdomen o la pelvis.
    Entre los síntomas de incomodidad del paciente, se incluyen las sensaciones de frío, calor o dolor. Se pedirá al sujeto que dé su opinión por separado acerca de la intensidad máxima de las sensaciones de dolor, calor y frío en una escala de 0 a 10 tras administrarle la inyección intravenosa rápida del MC y una vez que finalice la exploración de TC.
    La intensidad máxima de incomodidad del paciente se clasificará en 4 categorías: ninguna = 0; ligera= 1-3, moderada = 4-7; fuerte = 8-10. La incomodidad general del paciente se define como la puntuación máxima de incomodidad individual (es decir, dolor, calor o frío).
    E.5.1.1Timepoint(s) of evaluation of this end point
    El objetivo primario se evaluará hasta 10 minutos después de la inyección. Otras evaluaciones de seguridad se llevarán a cabo hasta 24 horas después de la inyección.
    E.5.2Secondary end point(s)
    Frecuencia de pacientes con incomodidad siguiendo la administración intra-arterial de Iodixanol 320 mg I/ mL o Iopamidol 370 mg I/mL para arteriografía periférica.
    Frequency of subjects with patient discomfort following intra-arterial
    administration of either iodixanol 320 mg I/mL or iopamidol 370 mg
    I/mL for peripheral arteriography.
    E.5.2.1Timepoint(s) of evaluation of this end point
    El objetivo primario se evaluará hasta 10 minutos después de la inyección. Otras evaluaciones de seguridad se llevarán a cabo hasta 24 horas después de la inyección.
    The primary end point will be evaluted up to 10 minutes after injection.
    Other safety assessments up til 24 hours after injection.
    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) Yes
    E.8.2.2Placebo No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Germany
    Spain
    United Kingdom
    United States
    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
    Desde la primera inclusión hasta la última visita del último sujeto.
    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 months1
    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 months1
    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 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.1.2.1Number of subjects for this age range: 125
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 125
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 210
    F.4.2.2In the whole clinical trial 300
    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)
    No hay ningún plan de tratamiento o cuidados posteriores de los pacientes que hayan terminado su participación en el ensayo.
    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 Decision2011-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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