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    Summary
    EudraCT Number:2015-005601-37
    Sponsor's Protocol Code Number:RBHP2015PICKERING4
    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:2016-03-02
    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 number2015-005601-37
    A.3Full title of the trial
    IMPACT OF 5% LIDOCAINE MEDICATED PLASTER ON ALLODYNIC SYMPTOMS OF LOCALIZED NEUROPATHIC PAIN AFTER KNEE SURGERY.
    A prospective, randomized, placebo controlled study in parallel groups.
    Impact de l’utilisation de patch de Lidocaïne 5% sur les douleurs neuropathiques à type d’allodynie après chirurgie du genou

    Étude prospective, randomisée, en double aveugle, contrôlée versus placebo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Localized Neuropathic pain and 5% lidocaine medicated plaster : LiNe
    Étude LiNe
    A.4.1Sponsor's protocol code numberRBHP2015PICKERING4
    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 Clermont-Ferrand
    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 supportCHU Clermont-Ferrand
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Clermont-Ferrand
    B.5.2Functional name of contact pointLACARIN
    B.5.3 Address:
    B.5.3.1Street Address58 Rue Montalembert
    B.5.3.2Town/ cityClermont-Ferrand
    B.5.3.3Post code63000
    B.5.3.4CountryFrance
    B.5.4Telephone number0033473751195
    B.5.5Fax number0033473754730
    B.5.6E-mailplacarin@chu-clermontferrand.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 Versatis® 5% emplâtre médicamenteux
    D.2.1.1.2Name of the Marketing Authorisation holder Laboratoires GRÜNENTHAL
    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.3.1Product nameVersatis® 5% emplâtre médicamenteux
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN.
    D.3.9.3Other descriptive nameLIDOCAINE
    D.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Post operative neuropathic pain (PONP)
    Douleur neuropathique post opératoire (DNPO)
    E.1.1.1Medical condition in easily understood language
    Post operative neuropathic pain (PONP)
    Douleur neuropathique post opératoire (DNPO)
    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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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
    The primary objective of this study is to investigate whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo.
    Evaluer l’évolution chronologique des symptômes allodyniques entre l’utilisation des patchs de Lidocaïne 5% comparée à l’utilisation de placebo avec différents tests (allodynie, test de pression et de température au chaud et froid).
    E.2.2Secondary objectives of the trial
    The secondary objectives will evaluate neuropathic pain (using the DN4 questionnaire for screening), qualitative and quantitative changes of allodynic symptoms (brush-induced Dynamic Mechanical Allodynia (DMA), Mechanical pressure Threshold (MDT), Cold (CDT) and Warm Thermal Detection (WDT) Thresholds), pain intensity (global pain by numerical scale (GP)), pain relief (NSr), patient global impression of change (PGIC), quality of sleep (Pittsburgh Sleep Quality Index (PSQI)), quality of life (SF12), Osteoarthritis severity (Western Ontario and McMaster Universities (WOMAC)), patients responders 30 % and 50 % and safety.
    1. Evaluer la douleur neuropathique par l’échelle DN4 à la visite de screening,
    2. Evaluer l’évolution de l’allodynie de manière quantitative et qualitative,
    3. Evaluer l’intensité et le soulagement de la douleur,
    4. Evaluer l’impact sur la qualité de vie par le questionnaire Patient Global Impression of Change (PGIC), l’Index de Qualité du Sommeil de Pittsburg (PSQI) et le Short Form 12 (SF-12), la sévérité de l’arthrose (WOMAC)
    5. Evaluer le taux de patients répondeurs à 30% et 50%,
    6. Evaluer les effets indésirables.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Aged from 18 to 80 years
    - Male or female, for women of childbearing potential, a negative pregnancy test
    - Patients with PONP following knee surgery
    - Patients with neuropathic pain DN4 ≥ 4
    - Patients at least 3 months post-surgery
    - Patients suffering from at least the allodynic brush-induced mechanical allodynia symptom (DMA) rated as ≥ 5/10 on the numerical scale
    - Patient with no localized neuropathic pain symptoms (DN4<4) on the contralateral knee
    - Intact skin besides the scar of surgery (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds) in the area where the medicated plasters will be applied
    - Naive from Versatis® treatment
    - Treated with stable systemic analgesic and planned to remain stable all over the duration of the study
    - Cooperation and understanding sufficient to meet study requirements
    - Agreement to give written consent
    - Insured by French social security
    - Included or agreement to be included in the national register of participants in biomedical research
    - Agés entre 18 et 80 ans,
    - Sexe Masculin ou Féminin (test de grossesse négatif pour les femmes en âge de procréer),
    - Patient présentant une douleur neuropathique post-opératoire (DNPO) à la suite d’une chirurgie du genou,
    - Patient présentant une douleur neuropathique évaluée par l’échelle DNA ≥ 4,
    - Patient étant à au moins 3 mois de la chirurgie,
    - Patient présentant au test d’allodynie mécanique dynamique un score ≥ 5/10 à l’échelle visuelle numérique (EVN),
    - Patient ne présentant pas de douleurs neuropathiques localisées (DN4<4) sur le genou opposé,
    - Patient présentant une surface cutanée intact au niveau de la zone d’application des patches (absence de symptômes dermatologiques tels qu’une irritation, une inflammation, une blessure, de l’herpès, une dermatose, etc),
    - Patient n’ayant pas été traité auparavant par Versatis®,
    - Traité avec des antalgiques systémiques de manière stable tout au long de la durée de l’étude,
    - Coopération et compréhension suffisantes pour se conformer aux impératifs de l’étude,
    - Acceptation de donner un consentement écrit,
    - Affiliation au régime de la Sécurité Sociale française,
    - Acceptation d’inscription au registre national des volontaires participant à des recherches.
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding women of childbearing potential who are sexually active without satisfactory contraception
    - Hypersensitivity to the Investigational Medicinal Product (IMP), its excipients, or anesthetics of the amide type
    - Patient treated by anti-arythmics (Class I) such as tocainide, méxilétine or other local anesthesic
    - Medical and/or surgical history that the investigator or his/her representative considers to be incompatible with the trial.
    - Ongoing pathology on the day of the inclusion (open wound, infection, …)
    - Patient currently enrolled in another clinical trial involving the use of an investigational drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study, or being in an exclusion period according to the French law, or having received a total amount of compensation higher than 4500 euros over the 12 months preceding the beginning of the trial
    - Patient benefiting from a legal protective measure (guardianship, curatorship).
    - Patiente enceinte ou allaitante ou n’ayant pas de contraception efficace pour les femmes en âge de procréer,
    - Hypersensibilité au produit à l’étude, ses excipients, ou aux anesthésiques de type amide,
    - Patient présentant une pathologie évolutive au moment du bilan d’inclusion,
    - Patient ayant des antécédents médicaux et/ou chirurgicaux jugés par l’investigateur ou son représentant comme étant non compatibles avec l’essai,
    - Patient participant à un autre essai clinique, ou se trouvant dans la période d’exclusion, ou ayant reçu un montant total d’indemnités supérieur à 4500 euros sur les 12 mois précédant le début de l’essai,
    - Patient avec coopération et compréhension ne permettant pas de se conformer de façon stricte aux conditions prévues par le protocole,
    - Patient bénéficiant d’une mesure de protection légale (curatelle, tutelle…),
    E.5 End points
    E.5.1Primary end point(s)
    Time to response to treatment defined as a 30% reduction in dynamic brush-induced mechanical allodynia on the localized pain area during the chronological period extending from inclusion to 3 months.
    Outcome defined as censored data and treated using appropriate statistical methods (Kaplan-Meier for univariate analysis and Cox proportional hazards model in multivariate context).
    Temps de réponse au traitement défini comme une réduction de 30% au test d’allodynie au niveau de la zone douloureuse localisée durant la période d’étude allant de l’inclusion à 3 mois.
    Les données censurées seront traitées par des méthodes statistiques appropriées (méthode de Kaplan-Meier pour l’analyse univariée et modèle de Cox pour l’analyse multivariée).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Inclusion (Day 0), Visit 2 (Day 7), Visit 3 (Day 15), Visit 4 (month 1), Visit 5 (Month 2), Visit 6 (Month 3)
    Inclusion (Jour 0), Visite 2 (Jour 7), Visite 3 (Jour 15), Visite 4 (Mois 1), Visite 5 (Mois 2), Visite 6 (Mois 3)
    E.5.2Secondary end point(s)
    Kinetics of evolution over time of the allodynic symptoms (pressure, hot, cold) obtained in both groups (Placebo and 5LP).
    2) Analysis (quantitative and qualitative) of the pathophysiology of neuropathic characteristics and DN4 questionnaire (at inclusion only)
    3) Evolution of the size of the allodynic area
    4) Responder rate, defined as 30% and 50% reduction over time on all allodynic symptoms
    5) Comparison of DMA, MDT, CDT and WDT to contralateral knee on the same anatomic location.
    6) Evolution of sleep and quality of life, patient global impression of change, osteoarthritis severity
    7) Compliance with treatment
    8) Safety and Adverse events
    1. Cinétique d’évolution dans le temps des symptômes d’allodynie (test mécanique et thermique) obtenue dans les deux groupes (placebo et 5LP),
    2. Analyse (quantitative et qualitative) de la physiopathologie des caractéristiques neuropathiques et questionnaire DN4 (à l’inclusion seulement),
    3. Evolution de la taille de la zone d’allodynie,
    4. Taux de répondeur, défini comme la réduction de 30% à 50% dans le temps des symptômes d’allodynie,
    CHU Clermont-Ferrand RBHP 2015 PICKERING 4
    Version 1 du 08-12-2015 5 / 12
    5. Comparaison des différents tests sur le genou opposé au niveau de la même zone (test d’allodynie mécanique dynamique, test de pression et test thermique),
    6. Evolution de la qualité du sommeil (PSQI), de la qualité de vie (PGIC, SF-12) et de la sévérité de l’arthrose (WOMAC)
    7. Evaluation des évènements et effets indésirables
    E.5.2.1Timepoint(s) of evaluation of this end point
    Inclusion (Jour 0), Visite 2 (Jour 7), Visite 3 (Jour 15), Visite 4 (Mois 1), Visite 5 (Mois 2), Visite 6 (Mois 3)
    Inclusion (Jour 0), Visite 2 (Jour 7), Visite 3 (Jour 15), Visite 4 (Mois 1), Visite 5 (Mois 2), Visite 6 (Mois 3)
    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 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
    Last patient Last Visit
    Dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    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: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state45
    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 Decision2016-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
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