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    The EU Clinical Trials Register currently displays   44313   clinical trials with a EudraCT protocol, of which   7357   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:2018-003559-39
    Sponsor's Protocol Code Number:ICO-A-2018-10
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-10-23
    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 ConcernedFrance - ANSM
    A.2EudraCT number2018-003559-39
    A.3Full title of the trial
    multicentric Study , open, randomized, comparing the topical treatment by patch of capsaïcine with 8 % ( Qutenza) to the oral prégabaline treatment in the early treatment of the neuropathic pains after a primary surgery for breast cancer ( CAPTRANE)
    Etude multicentrique, ouverte, randomisée, comparant le traitement topique par patch de capsaïcine à 8% (Qutenza) à la prégabaline per os dans le traitement précoce des douleurs neuropathiques après une chirurgie primaire pour cancer du sein (CAPTRANE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    multicentric Study , open, randomized, comparing the topical treatment by patch of capsaïcine with 8 % ( Qutenza) to the oral prégabaline treatment in the early treatment of the neuropathic pains after a primary surgery for breast cancer ( CAPTRANE)
    Etude multicentrique, ouverte, randomisée, comparant le traitement topique par patch de capsaïcine à 8% (Qutenza) à la prégabaline per os dans le traitement précoce des douleurs neuropathiques après une chirurgie primaire pour cancer du sein (CAPTRANE)
    A.3.2Name or abbreviated title of the trial where available
    CAPTRANE
    A.4.1Sponsor's protocol code numberICO-A-2018-10
    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 SponsorINSTITUT DE CANCEROLOGIE DE L'OUEST
    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 supportGRUNENTHAL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT DE CANCEROLOGIE DE L'OUEST
    B.5.2Functional name of contact pointPACTEAU Valérie
    B.5.3 Address:
    B.5.3.1Street AddressBD JACQUES MONOD
    B.5.3.2Town/ citySAINTHERBLAIN
    B.5.3.3Post code44805
    B.5.3.4CountryFrance
    B.5.4Telephone number+33240679908
    B.5.5Fax number+33240679787
    B.5.6E-maildrci@ico.unicancer.fr
    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 QUTENZA
    D.2.1.1.2Name of the Marketing Authorisation holderGRUNENTHAL
    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 Cutaneous patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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 PREGABALINE
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER
    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 Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    men and /or women older than 18 years with breast cancer for which a surgical operation was realized.
    homme et/ou femme de plus de 18 ans, atteint d’un cancer du sein pour lequel une intervention chirurgicale a été réalisée.
    E.1.1.1Medical condition in easily understood language
    men and /or women older than 18 years with breast cancer for which a surgical operation was realized.
    homme et/ou femme de plus de 18 ans, atteint d’un cancer du sein pour lequel une intervention chirurgicale a été réalisée.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to demonstrate non-inferiority of an early management strategy with capsaicin 8% topical treatment compared to conventional treatment with pregabalin on the evolution of neuropathic pain 2 months after randomisation in patients who received Surgical excision of breast cancer
    montrer la non-infériorité d’une stratégie de prise en charge précoce par traitement topique à la Capsaïcine 8% par rapport au traitement classique per os par prégabaline sur l’évolution de la douleur neuropathique 2 mois après la randomisation des patients ayant bénéficié d’une exérèse chirurgicale d’un cancer du sein.
    E.2.2Secondary objectives of the trial
    a)comparer l’efficacité d'une stratégie de prise en charge (PEC) précoce sur l’évolut° de la douleur neuropathique après 2 mois de traitement (ttt) dans les 2 bras
    b)comparer l’efficacité d’une stratégie de PEC précoce de ttt sur l’évolution de la douleur neuropathique après 6 mois de ttt dans les 2 bras
    c)Comparer le chgt fonctionnel perçu par les pts (activités, symptômes, émotions et QQV) après 2 et 6 mois de ttt entre les 2 bras.
    d)Comparer la régression de la surface douloureuse après 2 et 6 mois de ttt entre les 2 bras.
    e)Mesurer la tolérance de chaque type de ttt par recueil des effets 2ndaires dans chaque bras de ttt.
    f)Comparer l’évolution du poids entre les 2 bras après 6 mois de ttt.
    g)Dans le bras capsaïcine , estimer la proportion de pts pour qui 1 seule application a été suffisante.
    h)Evaluer l’impact anxiété et dépression péri-chirurgicale sur le dvpt de douleurs neuroathiques après une chir. du sein
    i)Estimer l’incidence des NICB 3 mois après une chir. du sein
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Homme ou femme ayant bénéficié d’une première chirurgie pour cancer du sein, quel que soit le type de chirurgie
    2)Age ≥ 18 ans
    3)Peau saine et non irritée sur les zones douloureuses à traiter
    4)Lors de la visite d’inclusion à M4 post chirurgie, douleur neuropathique du sein et/ou de la zone axillaire correspondant à une névralgie inter costo brachiale avec un score DN4≥4.
    5)Obtention du consentement écrit signé du patient
    6)Patient majeur affilié à un régime de la sécurité sociale
    E.4Principal exclusion criteria
    1)Contre-indications spécifiques aux traitements étudiés :
    a. prégabaline – hypersensibilité au principe actif ou à l’un des excipients
    b. capsaïcine - hypersensibilité au principe actif ou à l’un des excipients
    2)Patient diabétique
    3)Traitement antérieur par capsaïcine ou prégabaline
    4)Traitement opioïde > 80 mg/jour (équivalent morphine orale) en cours
    5)Traitement topique de la douleur entre la chirurgie et la visite d’inclusion
    6)Hypertension non contrôlée (pression artérielle systolique ≥ 180 mmHg ou pression artérielle diastolique ≥ 90 mmHg) ou antécédents récents d’événements cardiovasculaires (AVC, infarctus, embolie pulmonaire)
    7)Clairance de la créatinine (CLcr) < 60mL/min selon la formule de Cockcroft-Gault
    8)Femme enceinte, susceptible de l’être ou en cours d'allaitement
    9)Personnes privées de liberté ou sous tutelle (y compris la curatelle),
    10)Impossibilité de se soumettre au suivi médical de l'essai pour des raisons géographiques, sociales ou psychiques.
    E.5 End points
    E.5.1Primary end point(s)
    L’intensité de la douleur neuropathique est mesurée par l’échelle numérique en 11 points (0-10). Seront recueillies les intensités douloureuses pendant les 24h précédentes (nuit, soirée, après-midi, matinée). L’intensité douloureuse la plus élevée au cours des 24 dernières heures sera celle analysée pour répondre à l’objectif principal.
    L’évolution de l’intensité douloureuse est mesurée entre la randomisation (M4) et la visite d'évaluation (M6).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 2 months of treatment
    Après 2 mois de traitement
    E.5.2Secondary end point(s)
    a)L’échelle numérique en 11 points de la douleur est recueillie à la randomisation (M4) et à M6 (cf. critère de jugement principal).
    b)L’échelle numérique en 11 points de la douleur est également recueillie à M10.
    c)Les questionnaires PGIC, QLQ-C30 et EQ5D sont administrés à M4, M6 et M10 pour mesurer les changements fonctionnels et changements de qualité de vie ressentis par le patient dans les 2 bras de traitement.
    d)La surface douloureuse est mesurée à partir de la cartographie douloureuse à l’inclusion (M4), et après 2 (M6) et 6 mois (M10) de traitement. Elle est mesurée par l’aire délimitée par les contours de la surface douloureuse (relecture centralisée)
    e)La tolérance des traitements sera mesurée par le nombre de patients ayant eu au moins un événement indésirable de grade ≥ 2 selon la classification CTCAE v5.0.
    f)Le poids est recueilli à M4, M6 et M10
    g)Dans le bras capsaïcine, le nombre de patch total reçus par le patient pendant les 6 mois sera également recensé
    h)Le questionnaire HAD sera recueilli lors de la visite de screening, seuls les patients inclus dans l’étude ont développé des douleurs neuropathiques.
    i)L’incidence des NICB sera mesurée par le nombre de patients inclus dans l’étude (DN4+) par rapport au nombre de patients screenés avant la chirurgie
    E.5.2.1Timepoint(s) of evaluation of this end point
    Après 6 mois de traitement
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 Yes
    E.8.1.3Single blind No
    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 concerned18
    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 du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months1
    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: 272
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 500
    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 state772
    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 Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
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