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    Summary
    EudraCT Number:2006-003132-29
    Sponsor's Protocol Code Number:KF10004/03
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-01-31
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-003132-29
    A.3Full title of the trial
    Safety and efficacy of lidocaine 5% medicated plaster in comparison with pregabalin in postherpetic neuralgia and diabetic polyneuropathic pain
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberKF10004/03
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Numbern.a.
    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 No
    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 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.3.9.3Other descriptive name2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Lyrica® 75 mg hard capsules
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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.3.1Product nameLyrica® 75 mg hard capsules
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpregabalin
    D.3.9.1CAS number 148553.50-8
    D.3.9.2Current sponsor coden.a.
    D.3.9.3Other descriptive name(S)-3-(aminomethyl)-5-methylhexanoic acid
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    postherpetic neuralgia and painful diabetic polyneuropathy
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10054095
    E.1.2Term Neuropathic pain
    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 trial is to evaluate the safety and efficacy of lidocaine 5% medicated plaster versus pregabalin after 4 weeks of treatment in subjects with either postherpetic neuralgia or diabetic polyneuropathic pain.
    E.2.2Secondary objectives of the trial
    • To estimate the suitability of lidocaine 5% medicated plaster as stand-alone medication, as an alternative to and in combination with pregabalin.
    • To evaluate the safety and efficacy of lidocaine 5% medicated plaster in combination with pregabalin.
    • To evaluate the pregabalin-sparing effect of lidocaine 5% medicated plaster by down-titrating pregabalin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects with ≥ 18 years of age.
    • Written informed consent given.
    • For women of childbearing potential, a negative urine pregnancy test.
    • Negative urine test for drugs of abuse with the exception of short and medium acting benzodiazepine users for insomnia.
    • Intact skin in the area of topical treatment.
    • NRS-3 > 4 (recalled average pain intensity during the last 3 days)
    • Creatinine clearance (CLCR) > 30mL/min

    Subjects with painful DPN
    • Controlled, treated type 1 or 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) ≤ 11%.
    • Painful, distal, symmetrical, sensomotor polyneuropathy of the lower extremities for ≥ 3 months (below the knees on both extremities) with at least 2 of the following symptoms present: burning sensation, tingling or prickling, paresthesias, painful heat or cold sensation (e.g. warm or cold water).
    • The most painful area is coverable by up to 4 plasters.

    Subjects with PHN
    • Subjects with PHN and neuropathic pain present for ≥ 3 months after healing of the herpes zoster skin rash.
    • Without neurolytic neurosurgical therapy for their condition.
    E.4Principal exclusion criteria
    General
    • Evidence or history of alcohol, medication or drug abuse and/or dependency in the past 2 years, unstable psychological personality requiring intermittent or permanent treatment.
    • Psychiatric illness (subjects with well-controlled depression or anxiety disorder may participate if they are not taking any of the prohibited medications defined below), epilepsy or suicide risk.
    • Pregnant or breastfeeding women.
    • 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 (IUD) method with hormonal supplement, or male or female condom with diaphragm and a spermicidal agent [foam, jelly, or cream]). Satisfactory contraception must have been used for at least 28 days prior to enrollment, and is to be used during the trial and until 28 days after the follow-up visit. Women of childbearing age must be counseled about the use of adequate contraception.
    • Subjects with severe cardiac impairment e.g. NYHA class > 3, myocardial infarction less than 6 months prior to enrollment, and/or unstable angina pectoris.
    • Subjects with severe hepatic disorder and/or AST or ALT ≥ 3x the upper limit of normal.
    • Subjects with known or suspected severe renal failure (CLCR < 30 mL/min).
    • Anticipated need for surgery during the trial, requiring at least regional or general anesthesia.
    • Subjects who are undergoing active treatment for cancer, are known to be infected with HIV, or being acutely and intensively immunosuppressed following transplantation.
    • Participation in another trial of investigational medicinal products or devices parallel to or less than 1 month before entry into the trial, or previous participation in this trial.
    • Known to or suspected of not being able to comply with the trial protocol.
    • Not able to communicate meaningfully with the Investigator and staff.
    • 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.
    • The investigator may exclude any potential subject for any safety concern or any other reason that according to the investigator’s assessment makes the patient not suitable for this trial.

    Trial-specific
    • Any former treatment with topical lidocaine for treatment of neuropathic pain, pregabalin, or gabapentin (during the last 6 months).
    • Any concomitant use of drugs or therapies for the treatment of neuropathic pain or commonly used for the treatment of neuropathic pain e.g.:
    • Non-SSRI antidepressant drugs (i.e. tricylcic antidepressants, serotonin-norepinephrine reuptake inhibitors (SNRIs), e.g. venlafaxine, duloxetine).
    • Non-steroidal anti-inflammatory drugs (NSAIDs, including COX-2 inhibitors) if not specifically allowed per protocol.
    • Monoamine oxidase inhibitors (MAO-inhibitors),
    • antieleptic drugs (e.g. carbamazepine, clonzepam, phenytoin, valproic acid, lamotrigine, topiramate, gabapentin) besides the IMPs.
    • Benzodiazepines (except for short or medium acting benzodiazepines for insomnia).
    • Skeletal muscle relaxants.
    • Opioids (including dextromethorphan and tramadol), memantine, retinotoxins (e.g. hydroxychloroquine, deferoxamine, thioridazine, vigabatrin).
    • Transcutaneous electrical nerve stimulations (TENS).
    If concomitant medication needs to be tapered off, this taper-off must be started at Visit 1 and must be completed at Visit 2.
    • Known contraindications or hypersensitivity to local anesthetics of the amide type, pregabalin or paracetamol or to any of the excipients.
    • Intake of Class I anti-arrhythmic drugs (e.g. tocainide, mexiletine).
    • Administration of other local anesthetics (besides the IMPs).
    • Use of capsaicin in the last month prior to enrollment.
    • Galactose intolerance.
    • Lapp lactase deficiency.
    • Glucose-galactose malabsorption.
    • Evidence of another cause for pain in the area of neuropathic pain such as lumbar radiculopathy, surgery trauma, restless legs syndrome, if this could confound the assessment or self-evaluation of the neuropathic pain.
    • Presence of other severe pain that could confound the assessment or self-evaluation of neuropathic pain.
    • History of malignancy within the past 5 years (with the exception of basal cell carcinoma).

    Subjects with postherpetic neuralgia
    • Active herpes zoster lesion or dermatitis of any origin at the affected site.
    • Subjects who had neurological ablation by block or neurosurgical intervention for control of their pain.

    Subjects with diabetic polyneuropathy
    • No palpable pulse of the arteria dorsalis pedis in one foot or both feet.
    • Clinical signs for venous insufficiency and/or postthrombotic syndrome Stage III/IV (i.e. extensive varicosis).
    • Ulcers on the lower extremities.
    E.5 End points
    E.5.1Primary end point(s)
    Decrease of NRS-3 (recalled average pain intensity during the last 3 days) after 4 weeks of treatment with lidocaine 5% medicated plaster or pregabalin as stand alone medication, i.e. between Week 4 (Visit 4) and Baseline (Visit 2), expressed as a response rate. Response is defined as a reduction of at least 2 points or a value of 4 or less on the NRS-3 scale after 4 weeks of treatment. All drop-outs will be defined as non-responders
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    adaptive two-stage, stratified by indication
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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 concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of trial is defined as last subject out (LSO), meaning the date of the final follow-up visit for the last subject.
    Depending on the results of the interim analysis, the trial may be stopped prematurely.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-01-31. Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 278
    F.4.2.2In the whole clinical trial 350
    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)
    After trial termination, subjects will be treated by their physician for their respective disease according to the discretion of the physician.
    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 Decision2007-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-14
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