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    Summary
    EudraCT Number:2008-003914-87
    Sponsor's Protocol Code Number:BRD08/6-B
    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:2008-10-21
    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 number2008-003914-87
    A.3Full title of the trial
    Analyse de l’effet thérapeutique à trois mois des infiltrations du nerf pudendal dans les névralgies pudendales par syndrome canalaire.
    A.3.2Name or abbreviated title of the trial where available
    INFILTHERA
    A.4.1Sponsor's protocol code numberBRD08/6-B
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 DEPO MEDROL
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInfiltration use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMETHYLPREDNISOLONE ACETATE
    D.3.9.1CAS number 53361
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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.2.5The 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 nameSerum physiologique
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInfiltration use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 7647-14-5
    D.3.9.3Other descriptive nameSODIUM CHLORIDE
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Névralgie pudendale par syndrome canalaire
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10029226
    E.1.2Term Neuralgia NOS
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer, à moyen terme (3 mois), l’efficacité thérapeutique sur la douleur, de l’infiltration des corticoïdes du nerf pudendal dans les névralgies pudendales par syndrome canalaire.
    E.2.2Secondary objectives of the trial
    Evaluer la meilleure façon de réaliser ces injections et en particulier répondre aux questions suivantes :
    - L’hydrodissection obtenue par les infiltrations à grands volumes potentialise-t-elle l’action des corticoïdes sur la douleur ?
    - L’hydrodissection a-t-elle un effet propre sur la douleur ?
    - L’hydrodissection est-elle plus efficace quand la névralgie touche le périnée antérieur ?
    - Comment évolue l’action des infiltrations sur la douleur au cours du temps (J30, J60, J90) ?
    - Dans le cas d’une action des infiltrations sur la douleur, quel est leur impact sur la qualité de vie des patients ?
    -Les patients ayant un bloc diagnostic anesthésique positif sont-ils de meilleurs répondeurs au traitement que ceux ayant eu un bloc négatif ?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients présentant les 4 critères cliniques indispensables au diagnostic de névralgie pudendale selon les critères de Nantes 4:
    1/ douleur située dans le territoire du nerf pudendal (de l’anus à la verge ou au clitoris)
    2/ douleur prédominant en position assise
    3/ douleur ne réveillant pas la nuit
    4/ absence de déficit sensitif objectif
    et n’en ayant pas de critères d’exclusion :
    1/douleurs purement coccygienne, fessiere ou hypogastrique
    2/douleur uniquement paroxystique
    3/notion de prurit prépondérant
    4/présence d’anomalies d’imagerie susceptibles d’expliquer la symptomatologie
    - Patients des deux sexes de plus de 18 ans, souffrant depuis plus de 6 mois,
    - Patients n’ayant jamais eu d’infiltration strictement identique (site et latéralisation)
    à celle qui serait proposée dans le cadre du protocole et telle que définie dans la méthodologie
    - Patients n’ayant jamais été opéré du nerf pudendal
    - Patients informes et acceptant le protocole
    - Patients affiliés ou bénéficiant d’un régime de sécurité social
    - Patients considérés comme aptes à remplir les autoquestionnaires proposés
    - Patient ne participant pas à un autre protocole de recherche clinique durant la durée du protocole (de j-15 à j90)
    - patients ne présentant pas les contre indications aux injections de Xylocaïne*, de Dépomédrol * ou d’Omnipaque*
    - Douleur dont l’intensité mesurée sur la moyenne des EVA maximales notées lors des 15 jours précédents est supérieure ou égale a 40/100.
    E.4Principal exclusion criteria
    - Une douleur dont l’intensité est < 40/100
    - Patients incapables de tenir le carnet de suivi et de remplir les autoquestionnaires (raisons linguistiques, psychiatriques…)
    - Patient n’ayant pas tenu leur carnet d’EVA Max pendant au moins 5 jours pendant la période des 15 jours précédents J0.
    - Femmes enceintes à J0 (un test de grossesse sera réalisé pour les femmes non ménopausées sans contraception efficace)
    - Patients sous AVK le jour de l’injection (possibilité de faire un relais préalable par une héparine de bas poids moléculaire avec fenêtre thérapeutique)
    - Patient présentant une dépression marquée : plus de 16 /39 sur l’échelle de Beck
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal sera l’intensité de la douleur évaluée par échelle visuelle analogique (EVA de 0 à 100). La valeur prise en compte correspondra à la moyenne des valeurs maximales quotidiennes au cours des 15 jours précédant les visites médicales en centre, annotées sur un carnet de suivi.
    On comparera la moyenne des valeurs maximales relevées pendant les 15 jours précédant la visite d’inclusion (J0) et la moyenne des valeurs maximales relevées pendant les 15 jours précédant la visite à 90 jours de l’infiltration (J90).
    On considèrera comme efficace une infiltration qui permet soit un gain de 30 points sur 100 ou plus sur cette échelle soit un gain de 50% (ce qui est plus adapté pour les EVA les plus basses). Les autres seront considérés comme non améliorés. Les patients seront ainsi classés en deux groupes : améliorés ou non améliorés.
    Les patients qui auront rempli leur carnet de surveillance des EVA maximales pendant moins de 5 jours sur les 15 prévus pendant la période J75-J89 seront considérés comme non améliorés.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    stratifié
    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
    infiltration avec anesthésique seul sans les produits étudiés (depo-medrol, sérum physiologique)
    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 concerned10
    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 Information not present in EudraCT
    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
    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 months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    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 state201
    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)
    Identique à la prise en charge normale du patient
    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 Decision2008-10-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-11-18
    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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