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    Summary
    EudraCT Number:2020-003965-21
    Sponsor's Protocol Code Number:20VADS04
    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:2020-10-22
    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 number2020-003965-21
    A.3Full title of the trial
    Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.
    Phase II randomisée comparative visant à évaluer l’intérêt du Qutenza dans la prise en charge de patients en rémission de cancer ORL et présentant des douleurs neuropathiques séquellaires.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Randomized Controlled Study Aiming to Evaluate the Interest of Qutenza in Patients With ORL Cancer in Remission and With Sequellae Neuropathic Pain.
    Phase II randomisée comparative visant à évaluer l’intérêt du Qutenza dans la prise en charge de patients en rémission de cancer ORL et présentant des douleurs neuropathiques séquellaires.
    A.3.2Name or abbreviated title of the trial where available
    TEC-ORL
    TEC-ORL
    A.4.1Sponsor's protocol code number20VADS04
    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 CLAUDIUS REGAUD
    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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUT CLAUDIUS REGAUD
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressIUCT-O - 1, avenue Irène Joliot-Curie
    B.5.3.2Town/ cityTOULOUSE Cedex 09
    B.5.3.4CountryFrance
    B.5.4Telephone number+33531155445
    B.5.5Fax number+33531155896
    B.5.6E-mailboden.antoine@iuct-oncopole.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 holderAstellas Pharma
    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 Laroxyl®
    D.2.1.1.2Name of the Marketing Authorisation holderTeofarma
    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 Oral solution
    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
    Head and neck cancer
    Cancer ORL
    E.1.1.1Medical condition in easily understood language
    Head and neck cancer
    Cancer ORL
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10067821
    E.1.2Term Head and neck 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
    This study aims to compare the analgesic activity of capsaicin patch 8% applications at 3 months interval each on the cervico-facial area versus a reference neuropathic treatment with amitriptyline in patients with ORL cancer in remission and with neuropathic pain.
    Comparer l’activité antalgique de 3 applications de capsaïcine patch 8% à 3 mois d’intervalle chacune au niveau de la zone cervico-faciale versus un traitement neuropathique de référence par amitriptyline pour des patients en rémission présentant une douleur neuropathique séquellaire de la prise en charge d’une néoplasie ORL.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are :
    - A sensitivity study to assess the influence of managing pain other than neuropathic pain
    - Compare safety and tolerance between treatment arms
    - To compare the evolution of neuropathic pain between treatment arms
    - Compare quality of life between treatment arms
    Les objectifs secondaires de l’étude sont :
    - Une étude de sensibilité pour évaluer l’influence de la prise en charge d’une douleur autre que la douleur neuropathique
    - Comparer la sécurité et tolérance entre les bras de traitement
    - Comparer l’évolution de la douleur neuropathique entre les bras de traitement
    - Comparer la qualité de vie entre les bras de traitement
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age ≥ 18 years
    2.ORL cancer in remission: absence of clinical or radiological signs of progression at least 3 months after specific treatments.
    3.Pain of the cervico-facial sphere persisting for more than 3 months after surgical and/or radiotherapy treatment.
    4.Peripheral neuropathic character of pain objectified to a score ≥ 4/10 on the DN4 questionnaire.
    5.Pain whose average intensity over the last 24 hours is assessed on the numerical scale as ≥ 2/10.
    6.Patient affiliated to a Social Health Insurance in France.
    7.Patient who signed informed consent prior to inclusion in the study and prior to any specific study procedures.
    1. Age ≥ 18 ans.
    2. Néoplasie ORL identifiée comme étant en rémission : absence de signe clinique ou radiologique d’évolutivité au moins 3 mois après les traitements spécifiques.
    3. Douleur de la sphère cervico-faciale persistante depuis plus de 3 mois après la prise en charge par chirurgie et / ou radiothérapie.
    4. Caractère neuropathique périphérique de la douleur objectivé à un score ≥ 4/10 sur le questionnaire DN4.
    5. Douleur dont l’intensité moyenne sur les dernières 24 heures est évaluée sur l’échelle numérique (EN) comme étant ≥ 2/10.
    6. Patient affilié à un régime de sécurité sociale en France.
    7. Patient ayant signé son consentement éclairé avant l’inclusion dans l’étude et avant toute procédure spécifique pour l’étude.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1.ORL cancer in progression
    2.Other concomitant neoplasia (progressive or not).
    3.Central etiology of pain.
    4.Pain whose average intensity over the last 24 hours is assessed on the numerical scale as < 2/10.
    5.Allergy to any of the components of the capsaicin patch.
    6.Capsaicin patch not applicable to the area to be treated despite the precautions described in the protocol because of its proximity to mucous membranes or eyelids.
    7.Contraindication to amitriptyline treatment.
    8.Previous treatment with capsaicin or amitriptyline.
    9.Topical treatment of the painful area used for more than 21 days before inclusion.
    10.Ongoing opioid treatment > 80mg/day oral morphine equivalent.
    11.Uncontrolled high blood pressure or cardiovascular history (infarction, stroke, pulmonary embolism) less than 3 months ago.
    12.Patient included in another interventional therapeutic trial .
    13.Pregnant or breastfeeding patient.
    14.Any psychological, family, geographical or sociological condition that prevents compliance with the medical follow-up and/or procedures of the study protocol.
    15.Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
    1. Néoplasie ORL en évolutivité.
    2. Autre néoplasie concomitante (évolutive ou non).
    3. Etiologie centrale de la douleur.
    4. Douleur dont l’intensité moyenne sur les dernières 24 heures est évaluée sur l’échelle numérique comme étant < 2/10.
    5. Allergie à l’un des composants du patch de capsaïcine.
    6. Patch de capsaïcine non applicable sur la zone à traiter malgré les précautions décrites dans le protocole en raison de la proximité avec les muqueuses ou les paupières.
    7. Contre-indication au traitement par amitriptyline ou capsaïcine.
    8. Traitement antérieur par capsaïcine ou amitriptyline.
    9. Traitement topique de la zone douloureuse utilisé depuis plus de 21 jours avant l’inclusion.
    10. Traitement opioïde en cours > 80mg/jour équivalent morphine orale.
    11. Hypertension artérielle non contrôlée ou antécédent cardiovasculaire (infarctus, AVC, embolie pulmonaire) datant de moins de 3 mois.
    12. Patient inclus dans un autre essai interventionnel à visée thérapeutique.
    13. Patiente enceinte ou allaitante.
    14. Toute condition psychologique, familiale, géographique ou sociologique ne permettant pas de respecter le suivi médical et/ou les procédures prévues dans le protocole de l'étude
    15. Patients privés de liberté ou sous régime de protection juridique (curatelle et tutelle, sauvegarde de justice).
    E.5 End points
    E.5.1Primary end point(s)
    The Primary Outcome Measure is the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion.
    Le critère de jugement principal est le taux de patients présentant une diminution de la douleur moyenne sur les dernières 24h de 2 points à 9 mois par rapport à l’inclusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months for each patient
    9 mois pour chaque patient
    E.5.2Secondary end point(s)
    The Secondary Outcome Measures are:
    - For the sensitivity analysis, the endpoint will be defined as the rate of patients with a decrease in average pain over the last 24 hours by 2 points at 9 months compared to inclusion. Pain will be assessed using a numerical scale. Patients for whom pain management would be modified from the protocol will be considered failures. Patients with missing data for pain progression will be considered failures.
    - Neuropathic pain will be assessed using the Neuropathic Pain Symptom Inventory (NPSI) self-questionnaire developed and validated in French (Bouhassira, Pain 2014).
    - Adverse drug reactions (capsaicin and amitriptyline) will be assessed using the NCI-CTC AE V5.
    - Quality of life will be assessed using the EORTC QLQ-C30 questionnaire.
    Les critères secondaires sont :
    • Pour l’analyse de sensibilité le critère de jugement sera défini comme le taux de patient présentant une diminution de la douleur moyenne sur les dernières 24h de 2 points à 9 mois par rapport à l’inclusion. La douleur sera évaluée à l’aide d’une échelle numérique. Les patients pour lesquels la prise en charge de la douleur serait modifiée par rapport au protocole seront considérés comme des échecs. Les patients présentant une donnée manquante pour l’évolution de la douleur seront considérés comme des échecs.
    • La douleur neuropathique sera évaluée à l’aide de l’auto-questionnaire Neuropathic Pain Symptom Inventory (NPSI) développé et validé en français (Bouhassira, Pain 2014).
    • Les effets indésirables des médicaments (capsaïcine et amitriptyline) seront évalués à l’aide du NCI-CTC AE V5.
    • La qualité de vie sera évaluée selon le questionnaire QLQ-C30 de l’EORTC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months for each patient
    9 mois pour chaque patient
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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) No
    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 concerned5
    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 de suivi du dernier patient inclus
    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 months33
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months33
    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: 130
    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 Yes
    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 state130
    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 Decision2021-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-09
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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