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    Summary
    EudraCT Number:2016-000407-84
    Sponsor's Protocol Code Number:Beta-Dexa-Caudal
    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:2016-02-23
    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 number2016-000407-84
    A.3Full title of the trial
    Efficacy and safety of epidural administration of betamethasone and dexamethasone by caudal route for the treatment of radicular pain: randomized clinical trial.
    Eficacia y seguridad de la administración de betametasona frente a dexametasona por vía caudal para el tratamiento de las radiculalgias lumbosacras: ensayo clínico aleatorio
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lumbar epidural steroids.
    Corticoides en el espacio epidural lumbar.
    A.4.1Sponsor's protocol code numberBeta-Dexa-Caudal
    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 SponsorEnrique Bárez Hernandez
    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 supportBasque Health System
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBasque Health System
    B.5.2Functional name of contact pointEnrique Barez
    B.5.3 Address:
    B.5.3.1Street AddressJose Atxotegui s/n
    B.5.3.2Town/ cityVitoria-Gasteiz
    B.5.3.3Post code01009
    B.5.3.4CountrySpain
    B.5.4Telephone number945007276
    B.5.6E-mailENRIQUEMANUEL.BAREZHERNANDEZ@osakidetza.eus
    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 Celestone Cronodose
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp And Dohme De España, 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 IMPEpidural use
    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.IMP: 2
    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 Fortecortin
    D.2.1.1.2Name of the Marketing Authorisation holderMerck S.L.
    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.3.1Product nameFortecortin
    D.3.2Product code 36225
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEpidural use
    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
    radiculalgia
    radiculalgia
    E.1.1.1Medical condition in easily understood language
    lumbar pain
    dolor lumbar
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    Compare, 3 months after the last infiltration, the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale.
    Comparar el número de pacientes que logra una disminución del dolor según la escala numérica igual o superior al 50% entre los 2 grupos a los 3 meses tras la administración de la última infiltración
    E.2.2Secondary objectives of the trial
    - Compare the number of patients in each group who achieve a pain reduction of 50% or more according to the numerical rating scale per week, per month and 6 months after the last infiltration.
    - Compare the pain reduction according to numerical rating scale among patients in each group one week, one month and 6 months after the last infiltration.
    - Compare the degree of disability based on the Oswestry scale a week, a month, at 3 and at 6 months after the last infiltration.
    - Compare the consumption of opioid and non-opioid analgesics between both groups a week, a month, at 3 and at 6 months after last infiltration.
    - Compare, 6 months after the last infiltration, patients? satisfaction with the treatment.
    - Compare the quality of life according, to the quality of life SF-36 questionnaire a week, a month, at 3 and at 6 months after the last infiltration.
    - Compare the number of adverse events in each group.
    - Comparar el número de pacientes que logra una disminución del dolor según la escala numérica igual o superior al 50% entre los 2 grupos a la semana, al mes y a los 6 meses tras la la última infiltración
    - Comparar la reducción del dolor según la escala numérica en los pacientes de ambos grupos a la semana de la administración de la última dosis, al mes y 6 meses.
    - Comparar el grado de discapacidad según la escala de Oswestry a la semana, al mes, a los 3 y 6 meses tras la última infiltración
    - Comparar el consumo de analgésicos opiáceos y no opioides entre ambos grupos a la semana, al mes, a los 3 y 6 meses tras la última infiltración
    - Comparar el grado de satisfacción con el tratamiento referido por los pacientes a los 6 meses tras la última infiltración
    - Comparar la calidad de vida según el cuestionario de calidad de vida SF-36 a la semana, al mes, a los 3 y 6 meses tras la última infiltración
    - Comparar el número de eventos adversos producidos en cada grupo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Unilateral pain secondary to lateral stenosis, disc protrusion or herniation
    - Age between 18 and 80 years
    - Moderate-severe pain (?4 VAS)
    - Proper written and oral language proficiency
    - Dolor unilateral secundario a estenosis de canal lateral, protrusión discal o hernia discal
    - Edad entre 18 y 80 años
    - Dolor moderado-severo (EVN ?4)
    - Correcto dominio del idioma oral y escrito
    E.4Principal exclusion criteria
    - Patients with high intracranial pressure
    - Multiple sclerosis
    - Guillain-Barré Syndrome
    - Radiculopathy of vascular origin
    - Prior spinal surgery
    - Pregnant or lactating women
    - Allergy or intolerance to any of the drugs used in the study
    - Severe cognitive impairment
    - Radicular or intradural injection
    - Poorly controlled major psychiatric pathology
    - Type I diabetes
    - Type II uncontrolled diabetes (Hb1Ac?8, 5)
    - Glaucoma
    - Caudal equine syndrome
    - Previous treatment with steroids and/or anesthetic local infiltration
    - Central canal stenosis
    - Oral corticoid chronic treatment without fixed pattern
    - Pacientes con presión intracraneal alta
    - Esclerosis múltiple
    - Síndrome de Guillain-Barré
    - Radiculopatía de origen vascular
    - Cirugía de columna previa
    - Mujeres embarazadas o en periodo de lactancia
    - Alergia o intolerancia a cualquier de los fármacos utilizados estudio
    - Deterioro cognitivo grave
    - Radiculalgia por inyección intradural
    - Patología psiquiátrica mayor mal controlada
    - Diabetes tipo I
    - Diabetes tipo II mal controlada (Hb1Ac?8,5)
    - Glaucoma
    - Síndrome caudal equino
    - Tratamiento previo con infiltraciones de corticoides y/o anestésicos locales
    - Estenosis de canal central
    - Tratamiento crónico vía oral con corticoides sin pauta estabilizada
    E.5 End points
    E.5.1Primary end point(s)
    Pain: Numerical rating scale
    Dolor: escala númerica
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 week from last infiltration
    1, 3 y 6 months from last infiltration
    1 semana tras la última infiltración
    1, 3 y 6 meses tras la última inflitración
    E.5.2Secondary end point(s)
    Oswestry
    Analgesic consumption
    Quality of life(SF-36)
    Satisfaction with the treatment
    Adverse events
    Oswestry
    Consumo de analgésicos
    Calidad de vida (SF-36)
    Satisfacción con el tratamiento
    Efectos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 week from last infiltration
    1, 3 y 6 months from last infiltration
    1 semana tras la última infiltración
    1, 3 y 6 meses tras la última inflitración
    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) 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 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) Yes
    E.8.2.2Placebo No
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 300
    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 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 state360
    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
    No
    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 Decision2016-04-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-13
    P. End of Trial
    P.End of Trial StatusOngoing
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    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
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