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 are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42336   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).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    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:2015-000796-28
    Sponsor's Protocol Code Number:ECO-INTERMIOFASCIAL-4444
    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:2015-06-15
    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 number2015-000796-28
    A.3Full title of the trial
    A pilot, single-blind, placebo-controlled study to assess efficacy and safety of interfascial blockade of the painful trapezius muscle in patients with fribromyalgia
    EFICACIA Y SEGURIDAD DEL BLOQUEO INTER-FASCIAL EN EL TRATAMIENTO DEL DOLOR EN EL TRAPECIO DE PACIENTES CON FIBROMIALGIA: ESTUDIO PILOTO, ENMASCARADO A CIEGO SIMPLE Y CONTROLADO CON PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing the effect on pain and function of an anaesthetic injection with a placebo (non-active substance) for the treatment of pain at the trapezius muscle.
    Estudio que compara el efecto de una inyección anestésica en el dolor del músculo trapecio en pacientes con fibromialgia, comparado con una inyección de placebo (una sustancia sin actividad) sobre el dolor y otros síntomas funcionales
    A.4.1Sponsor's protocol code numberECO-INTERMIOFASCIAL-4444
    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 SponsorFundacio Clinic per a la Recerca Biomèdica
    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 supportHospital Clinic Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinic Barcelona
    B.5.2Functional name of contact pointUnidad de Fibromialgia
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number34932275400
    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 Bupivacaína B. Braun 2,5 mg/ml solución inyectable.
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Medical S.A. Ctra. Terrassa, 121 08191 Rubí (Barcelona)
    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 IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBupivacaíne hidrocloruro
    D.3.9.3Other descriptive nameBUPIVACAINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB00902MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Trapezius muscle pain in patients with fibromyalgia
    Dolor en el músculo trapecio en pacientes con fibromialgia
    E.1.1.1Medical condition in easily understood language
    Trapezius muscle pain in patients with fibromyalgia
    Dolor en el músculo trapecio en pacientes con fibromialgia
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10048439
    E.1.2Term Fibromyalgia
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles
    Comparar la eficacia en la mejoría del dolor del trapecio y su duración, en pacientes con fibromialgia sometidos a la administración regional de bupivacaina o placebo, en el espacio interfacial entre los músculos trapecio y supraespinoso.
    E.2.2Secondary objectives of the trial
    To compare the degree and duration of pain control in patients with fibromyalgia after a single injection of bupivacaine or placebo between trapezius and supraspinatus muscles
    Comparar la mejoría del dolor y duración del efecto, en pacientes con fibromialgia a los que se inyecta un anestésico (bupivacaina) o un placebo, en el espacio entre los músculos del cuello (trapecio y supraespinoso)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 or more
    2. Patients diagnosed of Fibromyalgia as primary cause of pain, according ACR 1990 criteria
    3. Not treated or on stable treatment for the last 3 months
    4. Spontaneous continuous pain at the upper trapezius muscle for more than three months with a VAS intensity above 4,
    5. Signed Written informed consent.
    1. Mayores de 18 años.
    2. - Pacientes que sufren de Fibromialgia como enfermedad principal y causa de su dolor, diagnosticada con criterios de ACR 1990
    3. Pacientes que no han iniciado un tratamiento nuevo, o reciben un tratamiento estable en los últimos tres meses.
    4. Presencia de dolor espontaneo, continuo, en el trapecio superior derecho y/o izquierdo de más de tres meses de duración, con una escala de intensidad del dolor con esta localización superior a 4, según EVA
    5. Firma del consentimiento informado.
    E.4Principal exclusion criteria
    1.Any non-controlled condition or disease (cardiovascular, endocrine, etc)
    2. Other neuromuscular, infectious, metabolic or inflammatory diseases.
    3. Current anticoagulant therapy or coagulation abnormalities
    4. Prior surgery at shoulder or spine level
    5. Active vertebral disease (cervical or thoracic)
    6. Joint or tendon disease affecting shoulder area
    7. Intolerance or hypersensitivity to bupivacaine or other local anaesthetic agents
    8. Pregnant or nursing women
    9. Skin lesions at the injection site
    10. Implantable devices for pain neuromodulation
    11. Patients undergoing the procedure previously
    1. Presencia de otras enfermedades metabólicas, endocrinológicas, cardiovasculares y viscerales no controladas.
    2. Presencia de otras enfermedades neuromusculares infecciosas, metabólicas o inflamatorias.
    3. Alteración de la coagulación o pacientes en tratamiento con anticoagulantes
    4. Antecedentes de Cirugía en columna cervical y/o hombros.
    5. Presencia de enfermedad vertebral activa en los segmentos cervical y/o dorsal.
    6. Presencia de enfermedad tendinosa o articular activa que afecte a hombros
    7. Intolerancia, hipersensibilidad o alergia a la Bupivacaina o a otros anestésicos locales.
    8. Pacientes embarazadas o en periodo de lactancia.
    9. Presencia de lesiones en la piel, eccemas, infecciones dérmicas en el área de administración del fármaco (trapecios).
    10. Dispositivos eléctricos implantados por el tratamiento del dolor (neuromodulación).
    11. Pacientes sometidos a este tipo de procedimento con anterioridad
    E.5 End points
    E.5.1Primary end point(s)
    Regional pain VAS at the trapezius muscle
    Escala Analógica Visual (EVA) de dolor regional del trapecio seleccionado para tratamiento,
    E.5.1.1Timepoint(s) of evaluation of this end point
    measured at weeks 2, 4 and 12 after treatment
    semanas 2, 4 y 12.
    E.5.2Secondary end point(s)
    General pain VAS
    Sleep quality Pittsburg Index (PSQI)
    Functional capacity(FIQ)
    QoL (SF-36)
    Anxiety / Deppression (HAD)
    Escala Analógica Visual (EVA) de dolor general del paciente.
    Valoración del sueño: Índice de Pittsburg (PSQI)
    Capacidad Funcional (FIQ)
    Calidad de Vida (SF-36)
    Nivel de ansiedad / Depresión (HAD)
    E.5.2.1Timepoint(s) of evaluation of this end point
    measured at weeks 2, 4 and 12 after treatment
    semanas 2, 4 y 12.
    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) 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 Yes
    E.8.1.4Double blind No
    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.8.2.4Number 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
    LVLS
    última visita del último paciente incluido
    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
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 No
    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
    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 Decision2015-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA