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    Summary
    EudraCT Number:2021-001494-23
    Sponsor's Protocol Code Number:RI-B-2021-7300-07
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-29
    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 number2021-001494-23
    A.3Full title of the trial
    EFFICACY OF ROUTINE MANAGEMENT BY LOCAL ANAESTHETIC INFILTRATION IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL AGAINST SALINE
    EFFICACITE DE LA PRISE EN CHARGE HABITUELLE PAR INFILTRATION D’ANESTHESIQUE LOCAL DANS LE TRAITEMENT DE LA NEVRALGIE PUDENDALE : ESSAI RANDOMISE CONTRE SERUM PHYSIOLOGIQUE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY OF ROUTINE MANAGEMENT BY LOCAL ANAESTHETIC INFILTRATION IN THE TREATMENT OF PUDENDAL NEURALGIA: A RANDOMISED TRIAL AGAINST SALINE
    EFFICACITE DE LA PRISE EN CHARGE HABITUELLE PAR INFILTRATION D’ANESTHESIQUE LOCAL DANS LE TRAITEMENT DE LA NEVRALGIE PUDENDALE : ESSAI RANDOMISE CONTRE SERUM PHYSIOLOGIQUE
    A.4.1Sponsor's protocol code numberRI-B-2021-7300-07
    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 SponsorGroupe Hospitalier Diaconesses-Croix-Saint-Simon
    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 supportGroupe Hospitalier Diaconesses-Croix-Saint-Simon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHôpital Fondation A. de Rothschild
    B.5.2Functional name of contact pointClinical research director
    B.5.3 Address:
    B.5.3.1Street Address29 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.4Telephone number33148036454
    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 LIDOCAINE AGUETTANT 10 mg/ml SANS CONSERVATEUR, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    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 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 CHLORURE DE SODIUM PROAMP 0,9 %, solution injectable
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE AGUETTANT
    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
    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 No
    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
    Patients with pudendal neuralgia who have failed drug treatment
    Patients atteints d’une névralgie pudendale en échec du traitement médicamenteux
    E.1.1.1Medical condition in easily understood language
    Patients with pudendal neuralgia who have failed drug treatment
    Patients atteints d’une névralgie pudendale en échec du traitement médicamenteux
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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
    Evaluate the effectiveness of NPTIs performed under neurostimulation on pain at 1 month after a local anaesthetic infiltration in the treatment of NP
    Evaluer l’efficacité des ITNP réalisées sous neurostimulation sur la douleur à 1 mois d’une infiltration d’anesthésique local dans le traitement des NP
    E.2.2Secondary objectives of the trial
    Compare between the two treatment arms:
    1) The rate of maintenance at 3 months of a positive response to the first infiltration.
    2) The rate of patients without pain at 1 month after the first infiltration.
    3) The evolution of quality of life and pain impact between inclusion and one month after the first infiltration.
    4) The evolution of anxiety and depressive disorders associated with pain between inclusion and one month after the first infiltration.
    5) The evolution of symptoms related to central sensitisation (both somatic and emotional) between inclusion and one month after the first infiltration.

    Comparer entre les deux bras de traitement :
    1) Le taux de maintien à 3 mois de la réponse positive à la première infiltration.
    2) Le taux de patients sans douleur à 1 mois de la première infiltration.
    3) L’évolution de la qualité de vie et du retentissement de la douleur entre l’inclusion et un mois après la première infiltration.
    4) L’évolution des troubles anxieux et dépressifs associés à la douleur entre l’inclusion et un mois après la première infiltration.
    5) L’évolution des symptômes liés à la sensibilisation centrale (à la fois somatiques et émotionnels) entre l’inclusion et un mois après la première infiltration.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient 18 years of age or older,
    - Express consent to participate in the study
    - Affiliated or beneficiary of a social security plan
    - With pudendal neuralgia (modified Nantes criteria).
    - MRI normal or without pathology explaining the pain
    - Failure of drug treatment as defined in the NPs, i.e. failure (VAS decrease < 3) of at least one antiepileptic and one antidepressant whose dosages were brought to the maximum possible or in whom a side effect did not allow the dose to be increased to its maximum allowed.
    - Patient âgé de 18 ans ou plus,
    - Consentement exprès de participation à l’étude
    - Affilié ou bénéficiaire d’un régime de sécurité sociale
    - Présentant une névralgie pudendale (critères de Nantes « modifiés »).
    - IRM normale ou sans pathologie expliquant les douleurs
    - Echec du traitement médicamenteux comme défini dans les NP, à savoir un échec (diminution EVA < 3) d’au moins un antiépileptique et d’un antidépresseur dont les posologies ont été amenées jusqu’au maximum possible ou bien chez qui un effet secondaire n’a pu permettre d’augmenter la dose jusqu’à son maximum autorisé.
    E.4Principal exclusion criteria
    Patient benefiting from a legal protection measure
    - Pregnant or breastfeeding woman
    - General and/or local infection (fistulous or cutaneous suppuration of the anal margin) in progress
    - Known neurological pathology that may explain the pain
    - Psychiatric pathology requiring medical treatment
    - Anticoagulants or haemostasis disorders
    - Hypersensitivity to lidocaine hydrochloride, local anaesthetics
    - Recurrent porphyrias
    - Patient bénéficiant d’une mesure de protection juridique
    - Femme enceinte ou allaitante
    - Infection générale et/ou locale (suppuration fistuleuse ou cutanée de la marge anale) en cours
    - Pathologie neurologique connue pouvant expliquer les douleurs
    - Pathologie psychiatrique nécessitant un traitement médicamenteux
    - Anticoagulants ou troubles de l’hémostase
    - Hypersensibilité au chlorhydrate de lidocaïne, aux anesthésiques locaux
    - Porphyries récurrentes
    E.5 End points
    E.5.1Primary end point(s)
    Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a decrease of at least 3 points on a visual analogue pain scale (VAS) between inclusion and 1 month after the first injection
    Comparaison entre les deux bras de traitement (lidocaïne versus sérum physiologique) du taux de patients avec diminution d’au moins 3 points sur une échelle visuelle analogique de douleur (EVA) entre l’inclusion et 1 mois après la première injection
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 month
    1 mois
    E.5.2Secondary end point(s)
    1) Maintenance of positive response at 3 months defined by a continued decrease of at least 3 points on the VAS (compared to inclusion) 3 months after infiltration.
    2) Percentage of patients with a VAS score of 0 at 1 month after the first infiltration.
    3) Delta of the score on question 9 of the "modified" Brief Pain Questionnaire (French version of the Brief Pain Inventory) concerning the impact of pain (Appendix 2).
    4) Delta of the scores A (anxiety dimension) and D (depression dimension) on the HAD scale (Appendix 3).
    5) Delta of the score for part A of the French version of the CSI central awareness score (Appendix 4).
    1) Maintien de la réponse positive à 3 mois défini par un maintien de la diminution d’au moins 3 points sur l’EVA (par rapport à l’inclusion) 3 mois après l’infiltration.
    2) Pourcentage de patients avec un score EVA égal à 0 à 1 mois de la première infiltration.
    3) Delta du score à la question 9 du Questionnaire Concis de la Douleur (QCD) « modifié » (version française du Brief Pain Inventory) s’intéressant au retentissement de la douleur (Annexe 2).
    4) Delta des scores A (dimension anxiété) et D (dimension dépression) à l’échelle HAD (Annexe 3).
    5) Delta du score à la partie A de la version française du score de sensibilisation centrale CSI (Annexe 4).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 and 3 months
    1 et 3 mois
    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 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 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 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
    LVLS
    dernière visite dernier patient
    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 months27
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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
    aucun
    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 Decision2021-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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