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    Summary
    EudraCT Number:2011-002083-25
    Sponsor's Protocol Code Number:LIDO2011
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-07-25
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-002083-25
    A.3Full title of the trial
    Is there a correlation between the pain relief and the A-delta- and C-fiber function after topical application of lidocaine (5%) in patients with peripheral neuropathic pain?
    Korreliert die Schmerzlinderung mit der A-Delta-und C-Faser-Funktion nach topischer Lidocain-Applikation (5%) bei Patienten mit peripheren neuropathischen Schmerzen?
    A.4.1Sponsor's protocol code numberLIDO2011
    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 SponsorBG University Hospital Bergmannsheil GmbH
    B.1.3.4CountryGermany
    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 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
    D.2.1.1.2Name of the Marketing Authorisation holderGrünenthal GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 IMPTopical use (Noncurrent)
    Cutaneous 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 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 placeboCutaneous patch
    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
    Patients with proven diagnosis of painful peripheral neuropathic pain syndromes as diagnosed as:
    1. Peripheral nerve lesion or
    2. Postherpetic neuralgia.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10036376
    E.1.2Term Post herpetic neuralgia
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10034586
    E.1.2Term Peripheral nerve injury
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of this trial is the assessment of the pain relief in patients suffering from peripheral neuropathic pain after treatment by topical application of lidocaine (5%).
    E.2.2Secondary objectives of the trial
    - Other sensory profile alterations in patients after treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Included will be patients 18 years and older either genera with:
    -Proven Diagnosis of painful peripheral neuropathy for at least 3 months as diagnosed as:
    1. Peripheral nerve lesion (i.e. pain within or adjacent to the area of nerve trauma or corresponding innervation territory or dermatome)
    or
    2. Postherpetic neuralgia (Subjects with pain following herpes zoster with > 3 months after healing of herpes zoster skin rash).
    - At least moderate pain intensity under the current treatment.
    - Unchanged and stable pain medication within the last 4 weeks.
    - The patients have to display some remaining sensory function at the baseline QST.
    - Intact skin in the area of lidocaine medicated plaster application.
    - Females with childbearing potential must be using adequate contraception.
    - Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-HCG) pregnancy test.
    E.4Principal exclusion criteria
    Excluded will be patients with:
    - History of current alcohol or drug abuse.
    - Any scheduled surgery of painful procedure during the course of the trial.
    - Presence of a disease that affects the subject’s compliance.
    - Use of any topical anaesthetics in the area of pain within the last 6 months.
    - Use of capsaicin (low or high-dose) in the area of pain within the last 6 months.
    - Use of TENS within the area of pain in the last 4 weeks.
    - Subjects who had nerve ablation by block or neurosurgical intervention for pain treatment at the affected area.
    - Evidence or another cause of pain within the area of pain or another severe pain condition that may interfere with the trial aims or procedures.
    - Severe loss of sensory function
    - Contraindications or hypersensitivity to local anaesthetics of amide type or to any of the exipients.
    - Intake of class I antiarrhythmic drugs (e.g. tocainide, mexilitine).
    - Use of systemically applied local anaesthetics within the last 4 weeks
    - Active herpes zoster lesion, dermatitis or skin lesions of any origin within the area of pain.
    - Clinically relevant cardiac insufficiency (NYHA Class III to IV)
    - Clinical relevant severe impairment of the kidney or liver function
    E.5 End points
    E.5.1Primary end point(s)
    - The amount of pain relief (NRS-3)
    - Number of treatment responders (as defined as subjects with a decrease of average pain (NRS-3) by > 30% at Visit 3 and Visit 5).
    - Decrease of A-delta- and C-fiber function after treatment using topical application of lidocaine (5%) or placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NRS-3 at Visit 3 (day 21) and Visit 5 (day 42) compared to baseline NRS-3 at Visit 2 (day 7) and 4 (day 24)
    E.5.2Secondary end point(s)
    - Changes of other QST parameters (tactile detection thresholds, thermal or mechanical hyperalgesia, dynamic mechanical allodynia).
    - To assess the symptom intensity and their possible changes after application of lidocaine (5%) the PainDETECT and NPSI (German version) questionnaire will be used at baseline and at each obligatory follow-up, the Patient Global Impression of Change scale (PGIC) will be used as a non-specific tool as well.
    - During the treatment a patient’s diary including the current, average and maximum pain intensity will be documented as well the intensity of some other complaints (e.g. nausea, drowsiness, sleep disorder etc.).
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Mode of action
    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 No
    E.8.1.6Cross over Yes
    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 concerned2
    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
    - Subject withdraws his/her informed written consent.
    - Serious or severe adverse event occuring under study treatment.
    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 months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 30
    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)
    Patients will be treated according to our clinical standards. Also see protocol.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-12-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-19
    P. End of Trial
    P.End of Trial StatusOngoing
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