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    Summary
    EudraCT Number:2013-001303-36
    Sponsor's Protocol Code Number:EMH-PRP-2013
    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:2013-08-14
    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 number2013-001303-36
    A.3Full title of the trial
    Intrarticular injections of platelet-rich plasma in pain?s treatment of the Osteoarthritic Knee
    INFILTRACIÓN INTRARTICULAR DE PLASMA RICO EN PLAQUETAS EN EL TRATAMIENTO DEL DOLOR DE RODILLA CON ARTROSIS
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of osteoarthritis knee pain injection concentrate a patient's own plasma
    Tratamiento del dolor de rodilla por artrosis por inyección de concentrado de plasma del propio paciente
    A.4.1Sponsor's protocol code numberEMH-PRP-2013
    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 Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    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 MAPFRE Medicina
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    B.5.2Functional name of contact pointProyect Manager
    B.5.3 Address:
    B.5.3.1Street AddressAv. Jorge Luis Borges nº15 Bl.3 Pl.3
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number0034951440260
    B.5.5Fax number0034951440263
    B.5.6E-mailpatricia.vergara@fundacionimabis.org
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPRP
    D.3.9.3Other descriptive namePLATELET CONCENTRATE
    D.3.9.4EV Substance CodeSUB14918MIG
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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 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
    Pain?s treatment of the Osteoarthritic Knee
    Disminución del dolor subjetivo en pacientes con rodillas artrósicas
    E.1.1.1Medical condition in easily understood language
    Osteoarthritis knee pain
    Dolor en rodilla por artrosis
    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
    The principal objective of this study is to determine the clinical value of intrarticular injections of platelet-rich plasma (PRP) in the reduction of perceived pain in patients with osteoarthritic knees
    El objetivo principal del estudio es determinar la utilidad clínica de la infiltración intrarticular de plasma rico en plaquetas (PRP) en la disminución del dolor subjetivo en pacientes con rodillas artrósicas. También, la repercusión funcional y en la calidad de vida que se logra.
    E.2.2Secondary objectives of the trial
    Effects on function and quality of life
    Repercusión funcional y en la calidad de vida que se logra.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Arthritis in the knee rated I, II, or III, VAS greater than 5, between 40 and 80 years of age.
    Gonartrosis I,II o III, EVA >5, edad de 40 a 80 años
    E.4Principal exclusion criteria
    Level IV arthritis of the knee, either surgery, corticoid infiltration, or viscosupplementation in the knee in the previous three months, frontal deformity greater than 10 degrees, ipsilateral pathology of the knee or ankle, range of motion or flexibility of the knee less than 90 degrees, deficit of knee extention greater than 15 degrees, anticoagulation treatment, antiplatement treatment, hepatopathy, hematological or neoplastic pathology, active infection, fibromyalgia, or chronic fatigue syndrome.
    Gonartrosis grado IV, cirugía o infiltración corticoidea o viscosuplementación en esa rodilla en los 3 meses previos, deformidad frontal mayor de 10º, patología de cadera o tobillo ipsilateral, movilidad de rodilla menor de 90º de flexión y déficit de extensión mayor de 15º, tratamiento anticoagulante, antiagregante, hepatopatía, patología hematopoyética o neoplásica o infección activa, fibromialgia o síndrome de fatiga crónica
    E.5 End points
    E.5.1Primary end point(s)
    The results will be evaluated using the Visual Analog Scale (VAS) for the principal variable
    Los resultados se valorarán aplicando la Escala Visual Analógica (EVA) para la variable principal y
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation will be conducted just after treatment, after three months, and after six months.
    La valoración se repetirá al finalizar el tratamiento, a los 3 meses y a los 6 meses.
    E.5.2Secondary end point(s)
    Knee and Osteoarthritis Outcome System (KOOS) and the EUROQOL ( European Quality of Life) for the evaluation of function and quality of life, respectively
    Escalas Knee and Osteoarthritis Outcome System (KOOS) y la escala European Quality of Life (EUROQOL) para la valoración funcional y de calidad de vida respectivamente
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluation will be conducted just after treatment, after three months, and after six months.
    La valoración se repetirá al finalizar el tratamiento, a los 3 meses y a los 6 meses.
    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 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 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
    Ácido hialurónico
    Hialuronic acid
    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
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 state50
    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 Decision2013-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-26
    P. End of Trial
    P.End of Trial StatusCompleted
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