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    Summary
    EudraCT Number:2009-016337-10
    Sponsor's Protocol Code Number:KF10004/08
    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:2010-03-22
    Trial results View 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 number2009-016337-10
    A.3Full title of the trial
    Lidocaine 5% medicated plaster for the topical treatment of localized chronic postoperative neuropathic pain after total knee replacement or thoracotomy
    A.4.1Sponsor's protocol code numberKF10004/08
    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 SponsorGrünenthal GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 Versatis 5 %, emplâtre médicamenteux
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires Grünenthal, 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.3.1Product nameVersatis
    D.3.2Product code GRT10004
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE
    D.3.9.1CAS number 137-58-6
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboMedicated plaster
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    localized chronic post-operative neuropathic pain (PoNP) after total knee replacement or thoracotomy (including drainage, excluding subjects with neoplasia-related thoracotomy)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10054711
    E.1.2Term Postoperative pain
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the analgesic efficacy of lidocaine 5% medicated plaster in comparison to placebo in subjects with moderate to severe localized chronic post-operative neuropathic pain (PoNP).
    E.2.2Secondary objectives of the trial
    To evaluate the effect of lidocaine 5% medicated plaster on quality of life, allodynia, and various symptoms of localized neuropathic pain in subjects suffering from localized chronic post-operative neuropathic pain (PoNP). To evaluate the safety and tolerability of lidocaine 5% medicated plaster in subjects suffering from localized chronic post-operative neuropathic pain (PoNP).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female subject aged ≥18 years at the Enrollment Visit (Visit 1).
    2. Subjects having understood the nature of the trial and having given written informed consent.
    3. Subjects able: to communicate meaningfully with investigational center staff, to comply with investigational center staff instructions, to comply with the planned use of the IMP, to complete the questionnaires, and to use the eDiaries.
    4. For women of childbearing potential, a negative pregnancy test (sample taken at the Enrollment Visit [Visit 1]).
    5. Subjects suffering from moderate to severe localized chronic PoNP following total knee replacement, or thoracotomy (including drainage, excluding subjects with neoplasia-related thoracotomy). Localized chronic PoNP is defined as chronic neuropathic pain in a single cutaneous area neurologically related to the site of surgery and following surgery.
    6. Total knee replacement or thoracotomy was performed ≤24 months prior to the Enrollment Visit (Visit 1).
    7. Subject assessment of the typical daily pain intensity at the Enrollment Visit (Visit 1) (NRS A_enroll) of ≤5 on the 11 point NRS using the provided questionnaire.
    8. Daily neuropathic pain present for ≥6 months prior to the Enrollment Visit (Visit 1).
    9. DN4 questionnaire score ≥4/10 (Bouhassira et al. 2005) at the Enrollment Visit (Visit 1).
    10. Presence of at least one of the following neurological symptoms: allodynia, dysesthesia or hypoesthesia; being present in the same neurological area as the localized chronic PoNP at the Enrollment Visit (Visit 1) (assessment based on DN4 outcomes).
    11. Size of the affected painful skin area not larger than 3 plasters.
    12. Healed skin (absence of skin disease, skin irritation, inflammation or injury, such as active herpes zoster lesions, atopic dermatitis, wounds, etc) in the area where the plasters will be applied.
    13. Subjects without concomitant medication for neuropathic pain or subjects receiving stable treatment (unchanged doses on ≥5 days in 7 days over 1 month prior to the Enrollment Visit [Visit 1] and planned to be maintained stable during the trial) for neuropathic pain, or subjects using non stable treatment for neuropathic pain prior to the Enrollment Visit (Visit 1), but agreeing to stop the non stable treatment from Visit 1 until the end of the Double blind Treatment Period (Visit 4).
    14. Calculated mean (NRS A_av) of the average 24 h daily pain intensities recorded in the eDiary during the Enrollment Period of ≥5 on the 11 point NRS (assessed at Visit 2); more than 80% of entries must be available since the Enrollment Visit (Visit 1).
    15. Compliance with use (i.e., completion of assessments) by means of eDiaries; more than 80% of entries must be available since the Enrollment Visit (Visit 1) (assessed at Visit 2).
    16. All laboratory values available before the Randomization Visit (Visit 2).
    E.4Principal exclusion criteria
    1. Participation in another trial of IMPs or devices parallel to, or <1 month prior to the Enrollment Visit (Visit 1), or previous participation in this trial.
    2. Any dependency of the subject to the Investigator or the trial center, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this Investigator or trial center, as well as family members of the employees or the Investigator.
    3. History of dependency or “active” drug abuse during the 3 years prior to the Enrollment Visit (Visit 1).
    4. Evidence or history (during the 3 years prior to the Enrollment Visit [Visit 1]) of alcohol, medication, or drug dependency.
    5. Evidence or history (during the 3 years prior to the Enrollment Visit [Visit 1]) of epilepsy, neurotic personality, psychiatric illness, or suicide risk.
    6. Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception. Contraception with a Pearl Index <1 is regarded as satisfactory (e.g., most oral contraceptives, intra uterine device method with hormonal supplement, or male or female condom with diaphragm and a spermicidal agent [foam, jelly, or cream]). Satisfactory contraception has not been used for ≥28 days prior to the Enrollment Visit (Visit 1) and patient does not agree to use it during the entire trial and until 28 days after the Final Visit (Visit 4) or the Withdrawal Visit. Women of childbearing age not counseled about the use of adequate contraception.
    7. Any surgery performed in the 3 months prior to the Enrollment Visit (Visit 1) or any surgery scheduled or expected during the trial.
    8. Clinically significant disease (e.g., acquired immunodeficiency syndrome), or condition (e.g., chronic inflammation in the operated area) which may affect efficacy or safety assessments, or any other reason which in Investigator’s opinion may preclude the subject’s participation in the trial.
    9. Any painful procedures planned during the trial that may, in the opinion of the Investigator, affect the efficacy or safety assessments.
    10. History of malignancy (with the exception of basal cell carcinoma) within the 2 years prior to the Enrollment Visit (Visit 1).
    11. Other painful conditions in the area of PoNP of infectious or non-infectious, inflammatory (e.g., arthritis) or neuropathic (e.g., neuropathies due to diabetes, chronic alcoholism, Lyme disease, acquired immunodeficiency syndrome, acute herpes zoster infection) causes, conditions representing a complication of the previous surgical procedure (e.g., intolerance to prosthetic material, hematoma), or diagnosis of complex regional pain syndrome type 1.
    12. Presence of total anesthesia in the neurological area of localized chronic PoNP (test performed at Enrollment Visit [Visit 1]).
    13. Thoracotomy related to neoplasia.
    14. Hypersensitivity towards the IMP, its excipients, or anesthetics of the amide type, or contraindication towards the rescue medication (Ben u ron 500 mg tablets).
    15. Severe cardiac impairment, e.g., New York Heart Association Class ≥ III, myocardial infarction within the 6 months prior to the Enrollment Visit (Visit 1), and/or unstable angina pectoris.
    16. Any former use of topical lidocaine for treatment of PoNP.
    17. Any use of Class I anti arrhythmic medicinal products (e.g., tocainide, mexiletine, flecainide, and intravenous lidocaine), or local anesthetics containing lidocaine or ketamine in the 3 days prior to Visit 1 or planned during the trial.
    18. Any topical treatment in the area of PoNP planned during the trial. Any topical treatment with capsaicin within the 6 months prior to the Enrollment Visit (Visit 1), or planned during the trial.
    19. Transcutaneous electrical nerve stimulation (TENS) or acupuncture applied for localized chronic PoNP at the enrollment or planned during the trial.
    20. Known severe renal impairment or a glomerular filtration rate/creatinine clearance <30 mL/min. The Cockroft and Gault formula will be used to calculate the creatinine clearance (Cockroft and Gault 1976) (sample taken at the Enrollment Visit [Visit 1]).
    21. Known severe hepatocellular insufficiency (Child Pugh ≥9) (Pugh et al. 1973, CPMP/EWP/2339/02) or aspartate aminotransferase or alanine aminotransferase ≥3 fold the upper limit of normal (sample taken at the Enrollment Visit [Visit 1]).
    22. Not being able to comply with the protocol and/or the use of the eDiary (assessment performed at Visit 2).
    23. Since the Enrollment Visit (Visit 1), any use of the forbidden concomitant treatment (see the synopsis section Forbidden concomitant treatments) including: the use of non stable concomitant medication for neuropathic pain; any change in dosage regimen of the stable concomitant analgesic medications, or new analgesic and co analgesic medication, capsaicin, or any other topical treatment of neuropathic pain, TENS, acupuncture.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the comparison of the Lidocaine and Placebo Plaster Arms for the change in pain intensity assessed on an 11 point NRS as NRS A7 at the end of the Double blind Treatment Period compared to the baseline (Enrollment Period).
    NRS-A7 for the primary endpoint will be the calculated mean of the eDiary entries of daily 24 h average pain intensity (NRS-A) over the last 7 days of the Enrollment Period (baseline) and of the treatment with IMP (e.g., before the Final Visit [Visit 4] or the Withdrawal Visit).
    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.8.3 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 concerned30
    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
    last visit of last subject
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=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)
    normal treatment of the condition
    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 Decision2010-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-27
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