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    Summary
    EudraCT Number:2009-010557-12
    Sponsor's Protocol Code Number:Version1.0/Jan2009
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-14
    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 ConcernedUK - MHRA
    A.2EudraCT number2009-010557-12
    A.3Full title of the trial
    A Single Blind, Randomised, Cross-over Study to Compare the Efficacy of Lidocaine 5% Plasters(Versatis) versus Pregabalin (Lyrica) in the Treatment of Complex Regional Pain Syndrome, Type 1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of Lidocaine 5% plasters and Pregabalin for the treatment of the painful condition called Complex Regional Pain Syndrome.
    A.3.2Name or abbreviated title of the trial where available
    Lidocaine vs. pregabalin in CRPS
    A.4.1Sponsor's protocol code numberVersion1.0/Jan2009
    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 SponsorThe Pennine Acute Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportThe Pennine Acute Hospitals NHS Trust
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Pennine Acute Hospitals NHS Trust
    B.5.2Functional name of contact pointResearch and Development Dept.
    B.5.3 Address:
    B.5.3.1Street AddressDelaunays Road
    B.5.3.2Town/ cityCrumpsall / Manchester
    B.5.3.3Post codeM8 5RB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401617202229
    B.5.5Fax number004401617204717
    B.5.6E-mailSteve.Woby@pat.nhs.uk
    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 holderGrunenthal Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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% Plaster
    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.3.9.3Other descriptive nameversatis 5% medicated plaster
    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 Yes
    D.3.11.13.1Other medicinal product typeWhite hydrogel plaster containing the active IMP, lidocaine and adhesive material with polyethylene terephthalate backing
    D.IMP: 2
    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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namepregabalin
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive namePREGABALIN
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 600
    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 Yes
    D.3.11.13.1Other medicinal product typehard capsule with active ingredient 'Pregabalin' along with lactose monohydrate
    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
    Complex regional pain syndrome type 1.
    E.1.1.1Medical condition in easily understood language
    Complex Regional Pain Syndrome, also called as Reflex Sympathetic Dystrophy or Sudeck's atrophy is a chronic painful condition often affecting an arm or leg with skin changes and swelling
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064334
    E.1.2Term Complex regional pain syndrome Type I
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective is to compare the analgesic efficacy of lidocaine 5% plaster and pregabalin as measured from the Brief Pain Inventory in complex regional pain syndrome type 1.
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    • To compare the responses to the quality of life issues, general activity, mood, walking ability, normal work, sleep, etc, as measured by the non-pain component of BPI, for Lidocaine 5% plaster and Pregabalin.
    • To compare the tolerability of Lidocaine 5% plaster and Pregabalin by the presence or absence of adverse effects and their severity (mild, moderate or severe).
    • To compare the area and threshold for mechanical allodynia using von Frey’s hairs for Lidocaine 5% plaster and Pregabalin.
    • To compare the results of Patient Global Impression of Change (PGIC), to Lidocaine 5% plaster and Pregabalin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients who meet all of the following criteria at the week 0 visit will be eligible for this study.

    1. Patients diagnosed with Complex Regional Pain Syndrome, type 1
    2. Patients aged >18 years.
    3. Patients who have had pain for > 3 months in duration.
    4. Patients who have an average pain intensity > 4 in 0-10 numerical rating scale (question 4 of the BPI), 0 being no pain and 10 being the worst pain one can imagine.
    5. Patients who are on a stable consumption (no change in medication or dosage) of pain medication for at least one month before the beginning of the study. Treatment may have included conventional neuropathic pain medications such as tricyclic antidepressants, antiepileptics (excluding gabapentin and pregabalin), tramadol, strong opioids and capsaicin but not lidocaine plasters or pregabalin.
    6. Patients who have stopped taking gabapentin for at least one month prior to the study start date, if gabapentin formed part of their previous treatment.
    7. Female patients who fulfil one of the following three criteria:
    • Post-menopausal, defined as amenorrhoea for at least 24 months together with an appropriate clinical profile (i.e., no alternative medical cause).
    • Not of child-bearing potential with a documented history of irreversible surgical sterilisation.
    • Of child-bearing potential with negative serum pregnancy test at week 0 visit and must have a history of consistent use of a highly effective method of birth control for the previous 3 months and be prepared to continue its use throughout the study and for 3 months after study completion.


    E.4Principal exclusion criteria
    A patient will not be eligible for inclusion in this study if any of the following criteria apply. The following criteria should be assessed at the week 0 visit.


    1. Patients with any other form of pain other than CRPS of similar or greater intensity.
    2. Previous use of either lidocaine plasters or pregabalin for CRPS or any other type of pain
    3. Patients who have a skin infection, inflammation or injuries with broken skin or insufficient wound healing at the site of application of the lidocaine plaster.
    4. Patients with a history of sensitivity to lidocaine or pregabalin.
    5. Patients who are receiving mexiletine, tocainide or other local anaesthetic medications.
    6. Patients taking any other form of topical medications for pain relief
    7. Patients on monoamine oxide inhibitors (MAOIs).
    8. Patients with a clinically relevant history or presence of dementia, severe depression or severe renal or hepatic impairment.
    9. Female patients who are pregnant or lactating.
    10. Patients judged to be unreliable or unable to understand the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The main outcome measures will be reduction in pain intensity rating and pain relief as measured from the Brief Pain Inventory (BPI).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pain intensity rating and pain relief will be measured at the following timepoints,

    Visits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 at
    Weeks 0, 2, 4, 6, 8, 10, 12,14, 16, 18 and 20 respectively.
    E.5.2Secondary end point(s)
    Measurement of change in non-pain components by the non-pain component of the Brief Pain Inventory
    Measurement of area and threshold of Mechanical Allodynia
    Measurement of change in the patient global impression scale
    E.5.2.1Timepoint(s) of evaluation of this end point
    Non-pain components are measured using the brief pain inventory at the following timepoints,

    Visits 0, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 at
    Weeks 0, 2, 4, 6, 8, 10, 12,14, 16, 18 and 20 respectively.

    Mechanical allodynia is measured by von Frey's hairs at the following timepoints,

    Visits 0, 4 and 10 at weeks 0, 8 and 20 respectively.

    The Change in Patient Global Impression Scale is measured at the following timepoints,

    Visits 4 and 10 at weeks 8 and 20.

    Visits
    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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    The study ends when 20 research participants are enrolled after satisfying the inclusion criteria
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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.1.2.1Number of subjects for this age range: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 20
    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)
    If the research participant benefits from the intervention during the clinical trial and if the results of the study prove the efficacy of intervention the participant will be given the option to continue the treatment. If the participant did not benefit from the intervention they will still continue to receive treatment and care from the pain specialists.
    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 Decision2009-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-24
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