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    Summary
    EudraCT Number:2018-002650-67
    Sponsor's Protocol Code Number:IBERepic/2018
    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:2018-08-10
    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 number2018-002650-67
    A.3Full title of the trial
    Comparison of the efficacy of autologous platelet rich plasma injections, and
    extracorporeal shock wave therapy, in the treatment of work –related lateral
    epicondylitis.
    Comparación de la eficacia de las infiltraciones con plasma autólogo rico en
    plaquetas y la terapia con ondas de choque extracorpóreas, en el tratamiento de la epicondilitis de origen laboral.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of plasma injections, and extracorporeal shock wave therapy, in the
    treatment of work –related lateral epicondylitis
    Eficacia de las infiltraciones con plasma y de la terapia con ondas de choque, en el
    tratamiento de la epicondilitis de origen laboral.
    A.3.2Name or abbreviated title of the trial where available
    Efficacy of PRP injections, and extracorporeal shock wave therapy, in occupational
    Eficacia de las infiltraciones con PRP y la terapia con ondas de choque en
    A.4.1Sponsor's protocol code numberIBERepic/2018
    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 SponsorIbermutuamur (Mutua Colaboradora con la Seguridad Social nº 274)
    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 supportIbermutuamur (Mutua Colaboradora con la Seguridad Social
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIbermutuamur (Mutua Colaboradora con la Seguridad Social nº 274)
    B.5.2Functional name of contact pointDepartamento Proyectos Sanitarios
    B.5.3 Address:
    B.5.3.1Street AddressCalle Ramirez de Arellano 27
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number34918385205
    B.5.5Fax number34914169699
    B.5.6E-mailevacalvo@ibermutuamur.es
    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 No
    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 nameplatelet rich plasma
    D.3.2Product code platelet rich plasma
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    Infiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNplatelet rich plasma
    D.3.9.3Other descriptive nameAUTOLOGOUS PLASMA
    D.3.9.4EV Substance CodeSUB126372
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number150000 to 400000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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
    The epicondylitis is an overuse injury, in most cases, is a self-limited course and
    responds well to conservative treatment. Its etiology is degenerative and is related
    to a repetitive overuse and underlying tendinopathy.
    La epicondilitis es una lesión provocada por movimientos repetitivos que en la
    mayor parte de los casos tiene un curso autolimitado y responde bien al tratamiento conservador. Su etiología es degenerativa y se relaciona con un sobreuso repetitivo y tendinopatía subyacente.
    E.1.1.1Medical condition in easily understood language
    The overuse of the muscles attached to the lateral bone of the elbow (epicondyle), as occurs in some jobs and also tennis players, causing its inflammation, known as epicondylitis.
    El uso excesivo de los músculos que se unen al hueso lateral del codo (epicóndilo), como ocurre en algunos trabajos y también en los tenistas, ocasionan su inflamación, conocida como epicondilitis.
    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
    To compare the efficacy of extracorporeal shockwave, infiltrations of autologous
    platelet-rich plasma and combination therapy with both, in patients with work-related epicondylitis, which do not respond to initial treatment with anti-inflammatory drugs and rehabilitation (level of pain, functional recovery, mobility, temporary disability and percentage of workers who require surgery).
    Comparar la eficacia del tratamiento con ondas de choque extracorpóreas, de las
    infiltraciones de plasma autólogo rico en plaquetas y de la terapia combinada con
    ambas, en pacientes con epicondilitis por contingencia profesional, que no
    responden al tratamiento inicial con anti-inflamatorios no esteroideos y
    E.2.2Secondary objectives of the trial
    To assess the cost-effectiveness of the three treatment care protocol modalities in controlling the work-related sick-leave period.
    Evaluar el coste-efectividad de las tres modalidades terapéuticas protocolo
    asistencial en el control de la incapacidad por contingencia profesional.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Workers diagnosed with work-related epicondylitis (ICD 9-CM code 726.32) as the primary diagnosis, receiving healthcare in Ibermutuamur. - Age equal or greater than 18 years. - Patients receive this diagnosis after being explored: painful sensitivity to pressure on the epicondyle; Cozen maneuver; chair test; and
    radiological examination. - Does not present remission of symptoms after a period of approximately 25 days of conservative treatment that include oral medication, local cold, functional relative rest and rehabilitation.
    - Trabajadores con diagnóstico de epicondilitis (Código CIE 9-MC 726.32) por
    Contingencia Profesional como diagnóstico principal, que reciben asistencia
    sanitaria en Ibermutuamur. Contingencia profesional se refiere a que el origen de la
    epicondilitis es una enfermedad profesional conforme a la normativa vigente, o bien
    tiene consideración de accidente de trabajo. - Edad igual o mayor a 18 años. -
    Diagnóstico de la patología tras exploración, empleando sensibilidad dolorosa a la presión sobre el epicóndilo; maniobra de Cozen; prueba de la silla; y exploración radiológica. - Ausencia de remisión de los síntomas tras un periodo de aproximadamente 25 días de tratamiento conservador, consistente en medicación oral, frío local, reposo funcional relativo y rehabilitación.
    E.4Principal exclusion criteria
    - Patients with cervical pathology. - With posterior interosseous neuropathy. - With any kind (unless cancer pathology hospital discharge) cancer. - Patients with mental health problems that prevent them from successfully follow rehabilitation treatment. - Patients with thrombocytopenia. - Patients who have pacemakers. - Clotting problems or anticoagulant therapy. - Rheumatoid arthritis diagnosed. - Pregnant or breast-feeding patients. - Treatment with deposit costicoesteroid infiltrations in the last 6 weeks
    - Pacientes con patología cervical. - Con neuropatía del interóseo posterior. - Con
    cáncer de cualquier tipo (salvo que esté de alta clínica de la patología cancerosa). -Pacientes con problemas de salud mental que les impida seguir de forma satisfactoria el tratamiento rehabilitador. - Pacientes con trombopenia. - Pacientes que disponen de marcapasos. - Problemas de coagulación o terapia
    anticoagulante. - Artritis reumatoide diagnosticada. - Mujeres embarazadas o en
    periodo de lactancia. - Tratamiento con infiltraciones de costicoesteroides de
    depósito en las últimas 6 semanas.
    E.5 End points
    E.5.1Primary end point(s)
    - Pain visual analog scale (VAS). - DASH (Disability of the Arm, Shoulder & Hand)
    score. - Variables biomechanical study - Ultrasound
    - Escala visual analógica del dolor (EVA) - DASH (Disability of the Arm, Shoulder &
    Hand) score - Variables del estudio biomecánico - Ecografía
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline: VAS and DASH scales (conventional therapy). 10 days: VAS, DASH,
    biomechanical assessment. 1 month: VAS, DASH, biomechanical assessment and
    ultrasound after physical rehabilitation if needed (recruitment and study group
    intervention assignment). 1 month: VAS and DASH. 2 months: biomechanical
    assessment and ultrasound. 3 months: VAS, DASH, biomechanical assessment
    and ultrasound.
    Basal: Escalas EVA y DASH. 10 días: EVA, DASH, valoración biomecánica. 1 mes:
    Escalas EVA, DASH, valoración biomecánica y ecografía. 1 mes. EVA y DASH. 2
    meses: Valoración biomecánica y ecografía. 3 meses: Escalas EVA, DASH,
    valoración biomecánica y ecografía.
    E.5.2Secondary end point(s)
    - Demographic variables. - Employer company and job variables. - Clinical
    variables.
    - Variables demográficas. - Variables de la empresa y del puesto de trabajo. -
    Variables clínicas.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Demographic variables: baseline. - Employer company and job: baseline. - Clinical variables: baseline and one year after the recruitment (end of the study).
    - Variables demográficas: inicio del estudio. - Variables de empresa y puesto de
    trabajo: inicio del estudio. - Variables clínicas: inicio del estudio y un año tras el
    reclutamiento (fin del estudio).
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    unicéntrico en España
    single site in Spain
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    After recuitment and intervention (October 2018-December 2019), LVLS is scheduled to be January 2020. Data analysis will be completing after that date and resultswill be available on June 2020.
    Después de reclutamiento y la intervención (Octubre 2018-Diciembre 2019), ),
    LVLS está programado para enero de 2020. El análisis de datos se estará
    completando después de esta fecha y los resultados estarán disponibles en Junio 2020.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 66
    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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    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)
    Most patients, will have complete resolution of symptoms with the PRP and
    extracorporeal shock wave therapy in the case withthe arm rest and non-steroidal
    anti-inflammatory drug (NSAID) therapy failed to resolve this condition. Patients with
    continued symptoms may require further treatment, including surgical debridement.
    The principal complication is continued pain. All other complications may arise from
    interventions attempting to alleviate that pain.
    La mayoría de los pacientes, presentarán una resolución completa de los síntomas
    con el PRP y la terapia con ondas de choque en el caso de que no se consiga con
    la terapia convencional. Los pacientes con síntomas continuos, pueden requerir un
    tratamiento adicional, incluyendo el desbridamiento quirúrgico. La principal
    complicación es el dolor continuo. Todas las otras complicaciones pueden surgir de
    las intervenciones que persigan como objetivo aliviar dicho dolor.
    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 Decision2018-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-29
    P. End of Trial
    P.End of Trial StatusOngoing
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