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    The EU Clinical Trials Register currently displays   44200   clinical trials with a EudraCT protocol, of which   7332   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).

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    Summary
    EudraCT Number:2021-001571-17
    Sponsor's Protocol Code Number:21-0148
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-11
    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 ConcernedFrance - ANSM
    A.2EudraCT number2021-001571-17
    A.3Full title of the trial
    Efficacité de la Dexaméthasone soluble par infiltrations échoguidées par le hiatus sacro-coccygien dans les sciatiques rebelles : étude prospective randomisée en double aveugle versus placebo
    A.3.2Name or abbreviated title of the trial where available
    DEXHIA
    A.4.1Sponsor's protocol code number21-0148
    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 SponsorCHU de Nantes
    B.1.3.4CountryFrance
    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 supportAppel d’offres interne 2020 CHU de Nantes
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nantes
    B.5.2Functional name of contact pointDirection recherche, CHU de Nantes
    B.5.3 Address:
    B.5.3.1Street Address5 allée de l'ille Gloriette
    B.5.3.2Town/ cityNantes
    B.5.3.3Post code44093
    B.5.3.4CountryFrance
    B.5.4Telephone number0033253482833
    B.5.5Fax number0033253482836
    B.5.6E-mailbp-prom-regl@chu-nantes.fr
    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 Dexaméthasone
    D.2.1.1.2Name of the Marketing Authorisation holderMylan SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPInfiltration
    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 Yes
    D.3.11.13.1Other medicinal product typeDexamethasone is a synthetic glucocorticoid (Cortisone and hydrocortisone)
    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 injection
    D.8.4Route of administration of the placeboInfiltration
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    refractory lumbosciatic patients
    patients lombo-sciatalgiques réfractaires
    E.1.1.1Medical condition in easily understood language
    persistent lumbosciatic patients
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10024251
    E.1.2Term Lesion of sciatic nerve
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To validate the efficacy of soluble Dexamethasone phosphate, injected through the Sacro-Coccygeal Hiatus, in the improvement of the clinical algofunctional picture of refractory lumbosciatalgic patients
    Valider l’efficacité du phosphate de Dexaméthasone soluble, injecté par la voie du HSC, dans l’amélioration du tableau clinique algofonctionnel de patients lombo-sciatalgiques réfractaires.
    E.2.2Secondary objectives of the trial
    1) Evaluate the effectiveness on lumbar pain
    2) Evaluate the effectiveness on sciatic pain
    3) Evaluate the functional handicap and the quality of life
    4) Evaluate the number of second injections needed
    5) Evaluate the number of patients undergoing secondary surgery
    6) Evaluate prognostic factors at S3, clinical and imaging
    7)Evaluate secondary effects
    1) Evaluer l’efficacité sur la douleur lombaire
    2) Evaluer l’efficacité sur la douleur sciatique
    3) Evaluer le handicap fonctionnel et la qualité de vie
    4) Evaluer le nombre de secondes injections nécessaires
    5) Evaluer le nombre de patients opérés secondairement
    6) Evaluer les facteurs pronostiques à S3, cliniques et d’imagerie
    7) Evaluer les effets secondaires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with sciatica of disc origin (radio-clinical concordance on MRI or CT) postero-lateral
    - Duration of evolution greater than 3 weeks despite analgesic / NSAID treatment, and less than 3 months
    - EVA sciatic pain > 4/10
    - Oswestry greater than or equal to 30 at inclusion
    - Patients présentant une sciatique d’origine discale (concordance radio-clinique à l’IRM ou au scanner) postéro-latérale
    - Durée d’évolution supérieure à 3 semaines malgré un traitement antalgique / AINS, et inférieure à 3 mois
    - EVA sciatique douleur > 4/10
    - Oswestry supérieur ou égal à 30 à l’inclusion
    E.4Principal exclusion criteria
    - Signs or risks of infection, in particular signs of viral infection (perform a screening PCR if there is any doubt that it is still a pandemic period when the protocol is set up)
    - Poor local skin condition
    - Anticoagulation with VKA or anti-Xa, or haemorrhagic disease (authorised antiaggregants)*.
    - Neurological deficit < 3/5 or signs of cauda equina irritation
    - Tarlov's cyst or low dural sac below S4
    - Allergy to Lidocaine, Dexamethasone or Sulphites
    - Spinal infiltration in the previous 3 months
    - Patient with bilateral sciatica
    - Patient with sciatica of arthritic origin
    - Patient with chronic respiratory failure
    - Signes ou risques d’infection, en particulier signe de virose (réalisation d’une PCR de dépistage au moindre doute si l’on est toujours en période pandémique lors de la mise en place du protocole)
    - Mauvais état cutané local
    - Anticoagulation par AVK ou antiXa, ou maladie hémorragipare (antiagrégants autorisés)*
    - Déficit neurologique < 3/5 ou signes d’irritation de la queue de cheval
    - Kyste de Tarlov ou cul de sac dural bas sous S4
    - Allergie à la Lidocaïne, à la Dexaméthasone ou aux Sulfites
    - Infiltration du rachis dans les 3 mois précédents
    - Patient présentant une sciatique bilatérale
    - Patient présentant une sciatique d’origine arthrosique
    - Patient atteint d’une insuffisance respiratoire chronique
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be a classical global algo-functional index, OSWESTRY, assessed at 3 weeks (difference D0 / S3).
    Le critère d’évaluation principal sera un index global algofonctionnel classique, l’OSWESTRY, évalué à 3 semaines (différence J0 / S3).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 3
    Semaine 3
    E.5.2Secondary end point(s)
    1) Low back pain VAS assessed at 1 week (S1), 3 weeks (S3), 6 weeks (S6), 12 weeks (M3) and 24 weeks (M6)
    2) VAS sciatica pain assessed at 1 week (S1), 3 weeks (S3), 6 weeks (S6), 12 weeks (M3) and 24 weeks (M6)
    3) Number of days off work, Oswestry at S1, S6, M3, M6 and SF36 self-questionnaires at S1, S3, S6, M3 and M6
    4) Second injection performed within 6 months (yes/no)
    5) Secondary surgery performed within 6 months (yes/no)
    6) Clinical and imaging parameters for assessment of low back pain
    7) VAS pain assessed immediately after the procedure and comprehensive collection of all side effects
    1) EVA douleur lombaire évaluée à 1 semaine (S1), 3 semaines (S3), 6 semaines (S6), 12 semaines (M3) et 24 semaines (M6)
    2) EVA douleur sciatique évaluée à 1 semaine (S1), 3 semaines (S3), 6 semaines (S6), 12 semaines (M3) et 24 semaines (M6)
    3) Nombre de jours d’arrêt de travail, Oswestry à S1, S6, M3, M6 et auto-questionnaires SF36 à S1, S3, S6, M3 et M6
    4) Deuxième injection réalisée dans les 6 mois (oui/non)
    5) Chirurgie réalisée secondairement dans les 6 mois (oui/non)
    6) Paramètres cliniques et d’imagerie d’évaluation d’une lombosciatique
    7) EVA douleur évaluée immédiatement après le geste et recueil exhaustif de tous les effets secondaires
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 1, 3, 6 12 and 24
    1 ère semaine, 3 semaines, 6 semaines, 12 semaines, 24 semaines
    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 Yes
    E.6.13.1Other scope of the trial description
    Assess quality of life and evaluate prognostic factors
    évaluer la qualité de vie et évaluer les facteurs pronostiques
    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 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
    It's the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    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) No
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 16
    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 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 state106
    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
    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 Decision2021-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-08-25
    P. End of Trial
    P.End of Trial StatusOngoing
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