Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7293   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-002608-34
    Sponsor's Protocol Code Number:ArAL11.1
    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:2011-10-03
    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 number2011-002608-34
    A.3Full title of the trial
    Comparation of the efficacy and onset of the distribution circumferencial va not ircumferencial of local anesthetic in the median and ulnar nerves for surgery of carpal tunnel
    COMPARACIÓN DE LA EFICACIA E INICIO DE ACCIÓN DE LA DISTRIBUCIÓN DE ANESTÉSICO LOCAL CIRCUNFERENCIAL vs NO CIRCUNFERENCIAL EN NERVIO MEDIANO Y CUBITAL PARA CIRUGÍA DE SÍNDROME DEL TÚNEL DE CARPO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparation of the efficacy and onset of the distribution circumferencial va not ircumferencial of local anesthetic in the median and ulnar nerves for surgery of carpal tunnel
    COMPARACIÓN DE LA EFICACIA E INICIO DE ACCIÓN DE LA DISTRIBUCIÓN DE ANESTÉSICO LOCAL CIRCUNFERENCIAL vs NO CIRCUNFERENCIAL EN NERVIO MEDIANO Y CUBITAL PARA CIRUGÍA DE SÍNDROME DEL TÚNEL DE CARPO
    A.3.2Name or abbreviated title of the trial where available
    ArAL
    ArAL
    A.4.1Sponsor's protocol code numberArAL11.1
    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 SponsorPaula Diéguez García
    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 supportPaula Diéguez García
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPaula Diéguez García
    B.5.2Functional name of contact pointPaula
    B.5.3 Address:
    B.5.3.1Street AddressAs Xubias de Arriba
    B.5.3.2Town/ cityA Coruña
    B.5.3.3Post code15006
    B.5.3.4CountrySpain
    B.5.4Telephone number687995525
    B.5.5Fax number981176380
    B.5.6E-mailpauladieguez@yahoo.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 Mepivacaina Braun ampolla 10 ml 1%
    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 nameMEPIVACAÍNA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPerineural use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEPIVACAINA HIDROCLORURO
    D.3.9.1CAS number 1722-62-9
    D.3.9.3Other descriptive nameMEPIVACAINE HYDROCHLORIDE, MEPIVACAÍNA CLORHIDRATO
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Sheduled patients for surgery of carpal tunnel
    Pacientes programados para cirugía del sindrome del túnel del carpo(STC)
    E.1.1.1Medical condition in easily understood language
    Sheduled patients for surgery of carpal tunnel and past de informed consent without exclusion factors
    Pacientes programados para síndrome del tunel del carpo que hayan firmado consentimiento informado previamente sin factores de exclusión
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10007695
    E.1.2Term Carpal tunnel decompression
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the clinical trial is the evaluation of the efficacy and onset of the distribution circumferencial vs no circumferencial of the local anesthetic around the median and ulnar nerves in sheduled patients for surgery of the carpal tunnel syndrom
    El objetivo principal del estudio es evaluar la eficacia y rapidez en el inicio de acción de la distribución circunferencial vs. no circunferencial de un anestésico local (AL), alrededor de los nervios mediano y cubital para pacientes programados para cirugía reparadora del síndrome del túnel del carpo
    E.2.2Secondary objectives of the trial
    The secundary objetives are: evaluation of the demography characteristics of the population, the postoperative time and spread local anesthetic around the median and ulnar nerves
    Los objetivos secundarios del estudio son: evaluar las características demográficas de la población a estudio, la evolución postoperatoria de los pacientes, valorar la distribución transversal y longitudinal del AL tras la inyección.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Sheduled patinets for surgery of carpal tunnel incluyed all patient clasification ASA I-III, without exclusion criterios and read and undestand and firm informed consent
    Pacientes programados para cirugía del Síndrome del Túnel del Carpo, incluyendo todos los pacientes estado físico clasificación ASA I-III, que no cumpla ningún criterio de exclusión y que haya leído y firmado el consentimiento informado.
    E.4Principal exclusion criteria
    Anormal bleeding, infection in the punction side, alergy or other problems with the medication of the study, muscular or nerve diseases, patients < 18 years old, pregnancy, cognitive disease or reject of the patient
    Evidencia de sangrado anormal, Infección en el lugar de la punción, contraindicaciones para las medicaciones del estudio, enfermedad muscular o neurológica, periférica o central preexistente, paciente menor de 18 años, embarazadas, alteración cognitiva y rechazo del paciente
    E.5 End points
    E.5.1Primary end point(s)
    The main variables are efficacy and onset of the median and ulnar block. The efficacy will detected with cold sensitivity, with cold cotton, on the fingers of blocked arm. The onset will detected with the exploration of sensitivity at 5, 15, 30 minutes after block nerve and at threat to Postoperative Room.
    Las variables principales del estudio son la eficacia e inicio de acción del bloqueo nervioso periférico (BNP) a nivel del nervio mediano y cubital. La medición de la eficacia se efectuará en base a la obtención de un bloqueo sensitivo óptimo en la zona quirúrgica según una escala obtenida detectando la falta de sensibilidad del paciente al frío en la zona bloqueada. La medición del inicio de acción se efectuará con la exploración del bloqueo sensitivo a los 5, 15 y 30 minutos después de la realización del BNP y a su llegada a la Unidad de Reanimación postoperatoria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the Postoperative room
    En la Unidad de Reanimación Postoperatoria
    E.5.2Secondary end point(s)
    The postoperative time and spread local anesthetic around the median and ulnar nerves
    La evolución postoperatoria de los pacientes, valorar la distribución transversal y longitudinal del AL tras la inyección.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 hours postoperative
    A las 24 horas del postoperatorio
    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 Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mismo medicamento pero se compara otra distribución de ese mismo medicamento alrededor del nervio
    The same medicinal product but in other distribution around the nerve
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    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 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.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 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 state124
    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 is different from expected normal treatment of that condition
    No es diferente a la práctica clínica habitual
    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 Decision2011-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 12:42:30 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA