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    Summary
    EudraCT Number:2009-015415-41
    Sponsor's Protocol Code Number:2009002
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2010-03-22
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-015415-41
    A.3Full title of the trial
    Lidocaine patches in postoperative and posttraumatic neuropathic chronic skin pain - A prospective, randomized, double-blinded, placebo-controlled, parrallel, multicentre, investigator initiated study according to clinical guidelines
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study focuses on chronic pain (pain that extends beyond the expected period of healing) states of a neuropathic (that results from an injury to the nervous system) nature, located at the scar or over a larger area of the skin around the scar. This post-operative/post-traumatic neuropathic chronic cutaneous pain (PNCCP) may be a side-effect of any incision of the skin in the context of a surgical procedure or a traumatic event.
    A.3.2Name or abbreviated title of the trial where available
    PNCCP Study
    A.4.1Sponsor's protocol code number2009002
    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 SponsorUniversitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Pijncentrum
    B.1.3.4CountryBelgium
    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 supportGrünenthal GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportGrünenthal SA/NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitair Ziekenhuis Antwerpen (UZA) - Multidisciplinair Pijncentrum
    B.5.2Functional name of contact pointGuy Hans
    B.5.3 Address:
    B.5.3.1Street AddressWilrijkstraat 10
    B.5.3.2Town/ cityEdegem
    B.5.3.3Post code2650
    B.5.3.4CountryBelgium
    B.5.4Telephone number+32(0)3821.49.45
    B.5.5Fax number+32(0)3821.45.60
    B.5.6E-mailguy.hans@uza.be
    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%
    D.2.1.1.2Name of the Marketing Authorisation holderSA Grunenthal NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Medicated plaster
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV 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 placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with postoperative or posttraumatic neuropathic chronic cutaneous pain
    E.1.1.1Medical condition in easily understood language
    Patients suffering from skin pain resulting from a trauma of a surgery
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    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 study objective is to evaluate lidocaine patches analgesic efficacy in patients with chronic (present for more than 3 months) postoperative or posttraumatic neuropathic cutaneous pain (PNCCP) in comparison with the situation before therapy (baseline situation) and in comparison with the placebo patches.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study consist of the evaluation of the effects of the lidocaine 5% patches, in comparison with placebo patches, on quality of life, intensity of neuropathic pain symptomatology, extent of the painful skin area and use of additionnal analgesics. In addition, impression of change (compared to baseline) will be evaluated both by the patient and by the physician.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -NRS > or = 5 and LANSS < or = 12 (as ca clear sign of severe neuropathic pain);
    -Neuropathic pain present for at least 3 months;
    -Clinical diagnosis of postoperative or posttraumatic neuropathic cutaneous chronic pain, where the diagnosis is made by the referring doctor and/or study investigator (pain should be clearly related to nerve damage during surgical procedure or trauma in terms of both location and tim of occurence);
    -The presence of cutaneous allodynia and/or hyperelgesia in the painful region;
    -Most painful skin area should be coverable by a maximum of 3 plasters;
    Presence of stable analgesic regimen (no change in this medication during 3 weeks before inclusion into the study);
    -Negative urine pregnancy test for women of childbearing potential;
    -Willingness of the patient to comply with the procedures of this clinical study, signing of an informed consent form and willingness to not increase the pre-existing analgesics (this is the average therapy in the period of one week prior to the start of the study) during the study period.
    E.4Principal exclusion criteria
    -Age < 18 or > 80;
    -Patients not on a stable medication for at least 3 weeks;
    -Patients not stable on a TENS treatment during the last 4 weeks, or any other treatment possibly confounding the evaluation of the study results;
    -Patients continuing use of any topically applied pain relief compound;
    -Pregnant women or lactating;
    -Women of chilbearing potential not willing to use an adequate contraception method (all study duration);
    -Infection in the painful version;
    -Poorly healed or non-healed wound or scar in the painful region;
    -Presence of exclusevely negative sensory symptoms (such as hypoesthesia);
    -The current presence of another chronic pain syndrome that is clincally more pronounced than the PNCCP and/or the opinion of the study investigator that another chronic pain syndrome is present in the patient which may have a significant impact on the evaluation by the patient of the effect of the study medication on the PNCCP;
    -The presence of postherpetic neuralgia;
    -The presence of postlamniectomy syndrome namely failed back or neck surgery syndrome with radiculopathy.;
    -The presence of another form of neuropathic pain and, in particular, painful sensory peripheral polyneuropathy;
    -Clinical suspicion and/or known presence of sensory disturbances present prior to the occurence of the PNCCP, for example in diabetes mellitus, polyneuropathy due to alcohol, radiation, radiotherapy, chemotherapy etc..(except for patients being in remission, having received for more than 2 years no active cancer treatment);
    -The presence of neurological disorders such as multiple sclerosis, CVA, spinal and/or brain disorders;
    -Known and/or strong suspicion of allergy to the study medication, known skin disorder;
    -Patients using steroid therapy;
    -History of or present cognitive and/or psychiatric disorder with possible impact on the reporting of the effect of the study medication by the patient;
    -Patients with ongoing medication litigation procedures are also excluded;
    -Other reasons according to the estimations of the investigator which may put the study subjects at risk or preclude adherence to the trial protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The intensity of the pain is measured on the weighted 11-point Numeric Rating Scale (NRS) will be measured during the screening visit (before topical treatment with lidocaine patches), at the start of the treatment, at every follow-up visits ( after 3 weeks and 8 weeks) and at the final visit (after 12 weeks).
    E.5.1.1Timepoint(s) of evaluation of this end point
    NRS will be measured during the screening visit (before topical treatment with
    lidocaine patches), at the start of the treatment, at every follow-up visits to the
    hospital (after 3 weeks, and 8 weeks) and at the final visit (after 12 weeks)
    E.5.2Secondary end point(s)
    a) Patient Global Impression of Change scale (PGIC) = Subjective experience of change in the intensity of pain
    b) Clinician Global Impression of change scale (CGIC) = Experience of change in the intensity of pain as evaluated by the physician
    c) Analgesic use is measured in terms of whether there is a reduction in the need of co-analgesics (number of analgesics and daily dose)
    d) Leeds Assessment of neuropathic Symptoms and Signs pain scale (LANSS) = Effect of study medication on neuropathic pain
    e) Neuropathic Pain Symptom Inventory scale (NPSI) = Detailed information concerning the presence of different neuropathic symptoms
    f) EQ-5D standardized questionnaire to measure health outcome
    g) Effect of the study medication on cutaneous sensory symptoms as measured by pin prick stimulation, sensory brush, and cold & warm
    h) The size of the painful area
    i) The average number of patches used on a daily basis
    j) Occurrence of side effects
    E.5.2.1Timepoint(s) of evaluation of this end point
    a) After 3 weeks, 8 weeks and 12 weeks
    b) After 3 weeks, 8 weeks and 12 weeks
    c) At day -1, after 3 weeks, 8 weeks and 12 weeks
    d) At day -1, after 3 weeks, 8 weeks and 12 weeks
    e) At day -1, after 3 weeks, 8 weeks and 12 weeks
    f) At day -1, after 3 weeks, 8 weeks and 12 weeks
    g) At day -1, after 3 weeks, 8 weeks and 12 weeks
    h) At day -1, after 3 weeks, 8 weeks and 12 weeks
    i) After 3 weeks, 8 weeks and 12 weeks
    j) At day 10, after 3 weeks, 8 weeks and 12 weeks
    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 Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 concerned10
    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 visit of the last subject undergoing the trial.
    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 months11
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months11
    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: 148
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 state222
    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)
    Expected normal treatment of that 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 Decision2010-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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