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    Summary
    EudraCT Number:2012-000347-28
    Sponsor's Protocol Code Number:KF10004/10
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-13
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2012-000347-28
    A.3Full title of the trial
    Efficacy and safety of lidocaine 5% medicated plaster in localized chronic post-operative neuropathic pain
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and tolerability of lidocaine for long-term local nerve pain
    A.4.1Sponsor's protocol code numberKF10004/10
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01752322
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1143-2130
    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 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 supportGrünenthal GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrünenthal GmbH
    B.5.2Functional name of contact pointGRT Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressZieglerstr. 6
    B.5.3.2Town/ cityAachen
    B.5.3.3Post code52078
    B.5.3.4CountryGermany
    B.5.4Telephone number+492415693223
    B.5.6E-mailClinical-Trials@grunenthal.com
    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% medicated plaster
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    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 nameLidocaine 5% medicated plaster
    D.3.4Pharmaceutical form Medicated plaster
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    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.3.9.4EV Substance CodeSUB08507MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 placeboMedicated plaster
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe localized chronic post-operative neuropathic pain
    E.1.1.1Medical condition in easily understood language
    long-term local nerve pain
    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 17.0
    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 is to assess the superiority of 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 other various symptoms of localized neuropathic pain in subjects suffering from moderate to severe localized chronic PoNP. To evaluate the safety and tolerability of lidocaine 5% medicated plaster in subjects suffering from moderate to severe localized chronic PoNP.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female subjects aged >18 years at Visit 1.
    Subjects having understood the nature of the trial and having given written informed consent.
    Subjects able to communicate meaningfully with investigational site staff, to comply with investigational site staff instructions, to comply with the planned use of the IMPs, to complete the questionnaires, and to use the e-diaries.
    For women of childbearing potential, a negative pregnancy test (sample taken at Visit 1).
    Subjects suffering from moderate to severe localized chronic PoNP in the location of a surgical intervention with a presumed local pain generator. Localized chronic PoNP is defined as chronic neuropathic pain on the surface of a single cutaneous area neurologically related to the site of surgery and following surgery (e.g., thoracotomy, total/partial knee replacement, cholecystectomy, mastectomy, inguinal hernia repair, varicose vein stripping).
    The surgery leading to PoNP was performed 3 to 36 months prior to Visit 1.
    Pain intensity at Visit 1 (subject’s average pain during the last 24 hours before the Enrollment Visit) of ≥4 on the 11 point NRS.
    Localized PoNP present for ≥3 months prior to Visit 1.
    Douleur neuropathique 4 (DN4) questionnaire score ≥4/10 at Visit 1.
    Size of the affected painful skin area is not larger than the size of 3 plasters.
    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 plasters will be applied.
    Adherence to the restricted use of concomitant treatments.
    Compliance with the use of e-diaries; at least 75% of all NRS entries must be available since Visit 1 (assessed at Visit 2). The percentage refers to the maximum number of expected e-diary entries based on the time span between Visit 1 and Visit 2.
    Baseline average pain intensity assessed at Visit 2 (mean of subject’s average pain intensities during the last 24 hours, calculated over the last 7 days of the Enrollment Period) of ≥4 on the 11 point NRS.
    E.4Principal exclusion criteria
    Participation in another trial of IMPs or devices parallel to, or <30 days prior to Visit 1, or previous participation in this trial.
    Any dependency of the subject to the investigator or the trial site, e.g., employees with direct involvement in the proposed trial or in other trials under the direction of this investigator or trial site, as well as family members of the employees or the investigator.
    History of dependency or “active” drug abuse (alcohol, medication) during the 1 year prior to Visit 1.
    Evidence or history (during the 3 years prior to Visit 1) of neurotic personality or psychiatric illness that in the investigator’s opinion may affect efficacy or safety assessments or may compromise the subject’s safety during trial participation.
    Pregnant or breastfeeding women or women of childbearing potential who are sexually active without satisfactory contraception.
    Any surgery performed in the 3 months prior to Visit 1, which may affect efficacy or safety assessment, or any surgery scheduled or expected during the trial.
    Clinically significant disease (e.g., acquired immunodeficiency syndrome) or condition that may affect efficacy or safety assessments, or any other reason which, in investigator’s opinion, may preclude the subject’s participation in the trial.
    Any painful procedure planned during the trial that may, in the opinion of the investigator, affect the efficacy or safety assessments.
    History of malignancy (with the exception of neoplasia related to the trial indication) within 2 years prior to Visit 1.
    Pending litigation due to chronic pain or disability.
    Other painful conditions in the area of PoNP of infectious or non infectious, inflammatory, or neuropathic causes, or conditions representing a complication of the previous surgical procedure which may affect efficacy or safety assessments.
    For subjects with PoNP related to a surgery due to neoplasia: suspected residual neoplasia or metastases.
    Presence of total anesthesia in the cutaneous area neurologically related to the location of surgical intervention (test performed at Visit 1).
    Hypersensitivity to the IMP, its excipients, or anesthetics of the amide type.
    Severe cardiac impairment, e.g., New York Heart Association Class ≥III, myocardial infarction in the 6 months prior to Visit 1, and/or unstable angina pectoris.
    Any former use of topical lidocaine in the area of localized chronic PoNP.
    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.
    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 (sample taken at Visit 1).
    Known severe hepatocellular insufficiency.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the change from baseline of recorded average pain intensity values during the last 24 hours, averaged over the 7 days of Week 12 of the Double-blind Treatment Period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 days of Week 12 of the Double-blind Treatment Period
    E.5.2Secondary end point(s)
    1) Mean pain intensity and mean pain intensity change from baseline based on the average pain intensity during the last 24 hours, calculated over the last 28 days (4 weeks) and 84 days (12 weeks) of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: last 28 days (4 weeks) and 84 days (12 weeks) of the Double blind Treatment Period
    2) Mean pain intensity and mean pain intensity change from baseline based on the current pain intensity before plaster removal, calculated over the last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: last 7 days, 28 days (4 weeks), and 84 days (12 weeks) of the Double blind Treatment Period
    3) Weekly mean pain intensities and weekly mean pain intensity change from baseline based on average pain intensity during the last 24 hours, and current pain intensity before plaster removal, respectively, calculated for each of the 12 weeks of the Double blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: each of the 12 weeks of the Double blind Treatment Period
    4) Responder rates (thresholds of 30% and 50% improvement compared to baseline) based on average pain intensity values during the last 24 hours at the end of the Double blind Treatment Period. All discontinued subjects will be considered non-responders except for those who do not require pain treatment any more due to absence of pain.
    Timepoint(s) of evaluation of this endpoint: the last 24 hours at the end of the Double blind Treatment Period
    5) Final score of the painDETECT Pain Questionnaire and the changes from baseline during the Double-blind Treatment Period.
    Timepoint(s) of evaluation of this endpoint: Visit 3, 4 and 5 of the Double blind Treatment Period.
    6) Pain intensity from mechanical dynamic allodynia (brush) testing and change from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 3, 4 and 5 of the Double blind Treatment Period
    7) Anxiety and depression scores of HADS and changes from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    8) Rating of global improvement and satisfaction with treatment according to PGIC using a 7 point verbal rating scale.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    9) The weighted Health Status Index of quality of life by means of EQ-5D and change from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    10) Total score in quality of sleep using CPSI and change from baseline.
    Timepoint(s) of evaluation of this endpoint: Visit 5 of the Double blind Treatment Period
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please see section E.5.2 (timepoint is given under listed secondary end point).
    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) 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 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 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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Brazil
    Chile
    Colombia
    Croatia
    Russian Federation
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months9
    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.1.2.1Number of subjects for this age range: 310
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 360
    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)
    n.a.
    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 Decision2012-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-06-21
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