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    Summary
    EudraCT Number:2017-004612-19
    Sponsor's Protocol Code Number:IIBSP-COR-2017-98
    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:2018-01-05
    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 number2017-004612-19
    A.3Full title of the trial
    EFFICACY OF THE SUPRAESCAPULAR NERVE APPROACH WITH CORTICOIDS ADMINISTRATION VERSUS PULSED RADIOFREQUENCY IN CHRONIC SHOULDER PAIN. DOUBLE BLIND RANDOMIZED CLINICAL TRIAL
    EFICACIA DEL ABORDAJE DEL NERVIO SUPRAESCAPULAR MEDIANTE LA ADMINISTRACIÓN DE CORTICOIDES VERSUS RADIOFRECUENCIA PULSADA EN EL DOLOR CRÓNICO DE HOMBRO. ENSAYO CLÍNICO ALEATORIZADO DOBLE CIEGO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY OF THE SUPRAESCAPULAR NERVE BLOCK IN CHRONIC SHOULDER PAIN TREATMENT
    EFICACIA DEL BLOQUEO DEL NERVIO SUPRAESCAPULAR EN EL TRATAMIENTO DEL DOLOR CRÓNICO DE HOMBRO
    A.4.1Sponsor's protocol code numberIIBSP-COR-2017-98
    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 SponsorInstitut de Recerca Hospital de la Santa Creu i Sant Pau
    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 supportInstitut de Recerca HSCSP
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca HSCSP
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number34935537812
    B.5.6E-mailepenag@santpau.cat
    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 Trigon depot
    D.2.1.1.2Name of the Marketing Authorisation holderBristol - Myers Squibb, S.A.
    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 Suspension 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 INNTRIAMCINOLONE ACETONIDE
    D.3.9.1CAS number 124-94-7
    D.3.9.4EV Substance CodeSUB04936MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number2.5 to 60
    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
    Chronic shoulder pain
    Dolor de hombro crónico
    E.1.1.1Medical condition in easily understood language
    Chronic shoulder pain
    Dolor de hombro crónico
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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
    Evaluation of the shoulder functionality and pain with the SPADI test (Shoulder Pain and Disability Index), in patients with chronic shoulder pain after tratment with suprascapular nerve block with corticoids versus pulsed radiofrequency.
    Evaluación de la mejora en funcionalidad y dolor en el hombro medida con el test SPADI, en pacientes con dolor crónico de hombro aplicando el bloqueo del nervio supraescapular con corticoides versus radiofrecuencia pulsada
    E.2.2Secondary objectives of the trial
    - Pain evaluation with visual analog scale (VAS) and numeric rating scale (NRS).
    - Shoulder range of movement evaluarion: elevation, abduction and external rotation.
    - Assessment of the reduction in the requirement of analgesics.
    - Assessment of the state of anxiety and quality of life (HAD test, EuroQoL 5D test).
    - Assessment of sleep quality (MOS scale)
    - Assessment of patient satisfaction with the treatment received.
    - Comparison of safety between both techniques
    - Valoración del dolor utilizando la escala visual analógica (EVA) y escala verbal numérica (EVN).
    - Valoración de la movilidad tanto activa como pasiva; rango de movimiento del hombro. Elevación, abducción y rotación externa del hombro.
    - Valoración de la disminución del requerimiento de analgésicos.
    - Valoración del estado de ansiedad y calidad de vida (escala HAD, EuroQoL).
    - Valoración de la calidad del sueño (escala MOS)
    - Valoración de la satisfacción del paciente con el tratamiento recibido.
    - Comparación de la seguridad entre ambas técnicas
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women with chronic shoulder pain proposed for suprascapular nerve block.
    - Age > 18 years
    - Painful shoulder for more than 3 months.
    - Informed consent document accepted
    - Hombres y mujeres propuestos para realización de bloqueo del nervio supraescapular por omalgia.
    - Edad >18 años
    - Omalgia de >3 meses de duración.
    - Firma del documento de consentimiento informado
    E.4Principal exclusion criteria
    - Corticoids allergy
    - Patient denial
    - Blood dyscrasias
    - Inabilility to perform infiltration due to technical difficulty
    - Not able to understand the informed consent document
    - Pregnancy or lactation
    - External causes of shoulder pain: secondary to cerevbrovascular accident, post-surgical, cervicobrachial syndrome
    - Polimyalgic syndromes
    - Participation in other studies that may alter the results
    - Alergia a corticoides
    - Negación del paciente
    - Discrasias sanguíneas
    - Imposibilidad de realizar la infiltración por dificultad técnica
    - No capacidad de comprensión del documento de consentimiento informado
    - Embarazo o lactancia
    - Causas externas de omalgia; secundaria a ictus, postquirúrgica (cirugía sobre el hombro, cirugía laparoscópica o cirugía torácica), síndrome cervicobraquial
    - Algias intensas en otras localizaciones
    - Participación en otros estudios que puedan alterar los resultados
    E.5 End points
    E.5.1Primary end point(s)
    SPADI test evaluation
    Test SPADI
    E.5.1.1Timepoint(s) of evaluation of this end point
    1st, 4th and 12th weeks
    1º, 4º y 12º semanas
    E.5.2Secondary end point(s)
    VAS and NRS evaluation
    Shoulder range of movement
    Analgesic requirements evaluation
    Anxiety and quality of life
    Quality of sleep
    Patient satisfaction
    Evaluación mediante EVA y EVN
    Rango de movimiento del hombro
    Cantidad de analgésicos administrados
    Ansiedad y calidad de vida
    Calidad del sueño
    Satisfacción del paciente
    E.5.2.1Timepoint(s) of evaluation of this end point
    1st, 4th and 12th weeks
    1º, 4º y 12º semanas
    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 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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Radiofrecuencia pulsada
    Pulsed radiofrequency
    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 sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    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: 76
    F.1.3Elderly (>=65 years) No
    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 state76
    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)
    The expected normal treatment of the condition
    Tratamiento habitual
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SCReN
    G.4.3.4Network Country Spain
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-28
    P. End of Trial
    P.End of Trial StatusOngoing
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