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    Summary
    EudraCT Number:2016-000623-73
    Sponsor's Protocol Code Number:LIDO
    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:2016-07-15
    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 number2016-000623-73
    A.3Full title of the trial
    LIDOCAINE IN ISCHEMIA-REPERFUSION INJURY FROM MICROSURGICAL BREAST RECONSTRUCTION. RANDOMISED UNICENTRIC, DOUBLE-BLIND, CLINICAL, CONTROLLED TRIAL.
    LIDOCAÍNA EN LA LESIÓN POR ISQUEMIA-REPERFUSIÓN EN RECONSTRUCCIÓN MAMARIA MICROQUIRÚRGICA. ENSAYO CLÍNICO, UNICÉNTRICO, ALEATORIZADO, CONTROLADO, DOBLE CIEGO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    LIDOCAINE IN ISCHEMIA-REPERFUSION INJURY FROM MICROSURGICAL BREAST RECONSTRUCTION.
    LIDOCAÍNA EN LA LESIÓN POR ISQUEMIA-REPERFUSIÓN EN RECONSTRUCCIÓN MAMARIA MICROQUIRÚRGICA.
    A.4.1Sponsor's protocol code numberLIDO
    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 SponsorFUNDACIÓN INVESTIGACIÓN BIOMÉDICA HOSPITAL PUERTA DE HIERRO
    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 supportFUNDACIÓN INVESTIGACIÓN BIOMÉDICA HOSPITAL PUERTA DE HIERRO
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACIÓN INVESTIGACIÓN BIOMÉDICA HOSPITAL PUERTA DE HIERRO
    B.5.2Functional name of contact pointFarmacología clínica
    B.5.3 Address:
    B.5.3.1Street AddressCalle Manuel de Falla, 1
    B.5.3.2Town/ cityMajadahonda, Madrid
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number+34911916481
    B.5.6E-mailfarmacologia_clinica@idiphim.org
    D. IMP Identification
    D.IMP: 1
    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.2.1.1.1Trade name Lidocaína B. Braun
    D.2.1.1.2Name of the Marketing Authorisation holderBRAUN
    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 nameLidocaína B. Braun
    D.3.2Product code Lidocaína B. Braun
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.3Other descriptive nameLIDOCAINE 1%
    D.3.9.4EV Substance CodeSUB12644MIG
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Ischemia-reperfusion injury from breast reconstruction microsurgical flaps.
    LESIÓN POR ISQUEMIA-REPERFUSIÓN DE LOS COLGAJOS MICROQUIRÚRGICOS DE RECONSTRUCCIÓN MAMARIA
    E.1.1.1Medical condition in easily understood language
    Is the tissue damage caused by the reperfusion of blood supply to flap after a period ischemia, which creates a condition of inflammation and oxidative damage.
    Es el daño tisular causado por la reperfusión del colgajo después de un período de isquemia, que produce inflamación y daño oxidativo.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    To evaluate the effect of lidocaine in the decrease of ischemic-reperfusion injury from breast microsurgical reconstruction, based on the MDA plasma levels at 12 hours after reperfusion.
    Evaluar el efecto de la lidocaína en la reducción del daño tisular producido por la isquemia-reperfusión en la cirugía de reconstrucción mamaria microquirúrgica, mediante la disminución de los niveles plasmáticos de MDA a las 12 horas de la reperfusión.
    E.2.2Secondary objectives of the trial
    1. To evaluate plasma levels of MDA at 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients.
    2. To evaluate SOD serum at 12 and 24 hours after reperfusion, in patients who received lidocaine, compared with untreated patients.
    3.To evaluate the percentage of surface flap necrosis in patients who received lidocaine compared with untreated patients trhough clinical assessment in Plastic Surgery medical appoinments at 7, 14 and 30 days after reperfusion.
    1. Evaluar los niveles plasmáticos de MDA a las 24 horas de la reperfusión, en las pacientes a las que se les administre lidocaína, comparando con las pacientes sin tratamiento.
    2. Evaluar los niveles séricos de SOD a las 12 y 24 horas de la reperfusión, en las pacientes a las que se les administre lidocaína, comparando con las pacientes sin tratamiento.
    3. Evaluar el porcentaje de superficie de necrosis del colgajo en las pacientes a las que se les administre lidocaína comparando con las pacientes sin tratamiento, mediante la evaluación clínica en consulta de Cirugía Plástica a los 7, 14 y 30 días de la reperfusión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Women between 18 and 70 years old including both ends, at the time of signing the informed consent, which are going to be operated on microsurgical breast reconstruction with DIEP flap abdominal type.
    Written informed consent in accordance with ICH / GCP and to the Spanish legislation, obtained before any study procedure.
    Mujeres con edades comprendidas entre 18 y 70 años, ambos extremos incluidos, en el momento de la firma del consentimiento informado, que vayan a ser intervenidas de reconstrucción mamaria microquirúrgica con colgajo abdominal tipo DIEP.
    ­Consentimiento informado escrito conforme a ICH/GCP y a la legislación española, obtenido antes de cualquier procedimiento de estudio.
    E.4Principal exclusion criteria
    - Pregnancy and lactation.
    - Have received prior radiation therapy.
    - Being a smoker.
    - Hypersensitivity or allergy to lidocaine and / or amide type local anesthetics, or any of its components.
    - Liver disease, heart disease or diabetic.
    - Patients who had received any investigational drug within 60 days prior to study drug administration.
    - Inability to give informed consent.
    - If there are findings on physical examination in the investigator's opinion, anomalies in the results of laboratory tests or other medical, social or psychosocial factors that could negatively influence
    - Embarazo o lactancia.
    - Haber recibido radioterapia previa.
    - Ser fumadora.
    - Hipersensibilidad o alergia a la lidocaína y/o anestésicos locales tipo amida, o a alguno de sus componentes.
    - Ser hepatópata, cardiópata o diabética.
    - Haber recibido cualquier fármaco en investigación en los 60 días anteriores a la administración del fármaco del estudio.
    - Incapacidad para dar el consentimiento informado.
    - Si en opinión del investigador existen hallazgos en la exploración física, anomalías en los resultados de los análisis clínicos u otros factores médicos, sociales o psicosociales que pudieran influir negativamente.
    E.5 End points
    E.5.1Primary end point(s)
    MDA plasma levels at 12 hours after reperfusion
    ­Niveles plasmáticos de MDA a las 12 horas de la reperfusión
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 hours after reperfusion.
    12 horas después de la reperfusión.
    E.5.2Secondary end point(s)
    MDA plasma levels 24 hours after reperfusion.
    SOD serum levels 12 hours after reperfusion.
    SOD serum levels 24 hours after reperfusion.
    Partial surface or total flap fat necrosis, according to clinical criteria based on the measurement area to total necrosis of the flap. This standard will bemeasured by photography and paper overlay grid.
    - Niveles plasmáticos de MDA a las 24 h de la reperfusión.
    - Niveles séricos de SOD a las 12 h de la reperfusión.
    - Niveles séricos de SOD a las 24 h de la reperfusión.
    - Superficie de necrosis grasa parcial o total del colgajo, según criterios clínicos basados en la medición del área de necrosis con respecto al total del colgajo. Se usará para ello fotografía estandarizada y la superposición de papel con cuadrícula.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 and 24 hours after reperfusion.
    7,14,30 days after reperfusion.
    12 y 24 horas después de la reperfusión.
    7,14,3 días despues de la reperfusión.
    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 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 No
    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 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 No
    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
    Last visit of the last subject undergoing the trial
    Se define como final del estudio la realización de la última visita del último paciente incluido 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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state20
    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
    ninguno
    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 Decision2016-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-12
    P. End of Trial
    P.End of Trial StatusOngoing
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