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    Summary
    EudraCT Number:2011-005872-41
    Sponsor's Protocol Code Number:QTZ-EC-0004
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-08-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-005872-41
    A.3Full title of the trial
    QUTENZA versus pregabalin in subjects with peripheral neuropathic pain: an open-label, randomized, multicenter, non-inferiority efficacy and tolerability study.
    Studio multicentrico, in aperto, randomizzato, di non-inferiorita' per determinare efficacia e tollerabilita' di QUTENZA versus pregabalin in soggetti con dolore neuropatico periferico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of efficacy and safety of Qutenza versus Lyrica
    Confronto di efficacia e sicurezza di Qutenza versus Lyrica
    A.3.2Name or abbreviated title of the trial where available
    ELEVATE
    ELEVATE
    A.4.1Sponsor's protocol code numberQTZ-EC-0004
    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 SponsorASTELLAS PHARMA
    B.1.3.4CountryItaly
    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 supportAstellas Pharma Europe Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASTELLAS PHARMA (AFFILIATE)
    B.5.2Functional name of contact pointServizio Informazione sulla Sperime
    B.5.3 Address:
    B.5.3.1Street AddressVia Delle Industrie
    B.5.3.2Town/ cityCarugate Milano
    B.5.3.3Post code20061
    B.5.3.4CountryItaly
    B.5.4Telephone number02 921381
    B.5.5Fax number02 92138217
    B.5.6E-mailCATIA.DICIANNI@IT.ASTELLAS.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 QUTENZA*1CER 179MG+1GEL DET
    D.2.1.1.2Name of the Marketing Authorisation holderASTELLAS PHARMA SpA
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCAPSAICIN
    D.3.9.1CAS number 404-86-4
    D.3.9.2Current sponsor codeNGX-4010
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number179
    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.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*100CPS 75MG
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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.3.9.4EV Substance CodeSUB10023MIG
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients who have a documented diagnosis of probable or definite Peripheral Neuropathic Pain
    Pazienti con diagnosi probabile o certa di dolore neuropatico periferico.
    E.1.1.1Medical condition in easily understood language
    Patients who have neuropathic pain due to shingles, injured nerve or a disease of a specific nerve as diagnosed by a physician.
    Pazienti affetti da dolore neuropatico dovuto a herpes, lesione dei nervi o ad una patologia a carico di uno specifico nervo come diagnosticato dal medico.
    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 10054095
    E.1.2Term Neuropathic pain
    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
    To compare the efficacy of Qutenza versus Pregabalin in subjects with peripheral neuropathic pain (PNP)after 8 weeks.
    Confrontare l'efficacia di Qutenza versus Pregabalin in soggetti affetti da dolore neuropatico periferico(PNP)dopo 8 settimane.
    E.2.2Secondary objectives of the trial
    •To compare the optimal therapeutic effect of QUTENZA versus pregabalin in subjects with PNP •To compare the: − onset of treatment effect associated with QUTENZA or pregabalin − tolerability of treatment with QUTENZA or pregabalin − effect of QUTENZA or pregabalin on cognition, sleep and health-related quality of life − satisfaction with treatment with QUTENZA or pregabalin − healthcare resource utilization following treatment with QUTENZA or pregabalin − safety of treatment with QUTENZA or pregabalin • To identify sensory symptoms predictive of a reduction in pain scores for subjects receiving QUTENZA • To evaluate the effect of treatment with QUTENZA or pregabalin on the intensity and area of allodynia • To examine the impact of pain relief and treatment tolerability on health-related quality of life as determined by the relationship between relevant endpoints.
    •Confrontare l'effetto terapeutico ottimale di QUTENZA vs pregabalin in soggetti affetti da PNP Confrontare: −comparsa dell'effetto del trattamento con QUTENZA o pregabalin−tollerabilità con QUTENZA o pregabalin−effetti di QUTENZA o pregabalin su capacità cognitive,sonno e qualità di vita correlata alla salute−soddisfazione rispetto al trattamento con QUTENZA vs pregabalin−ricorso a risorse sanitarie in seguito a trattamento con QUTENZA vs pregabalin−sicurezza del trattamento con QUTENZA o pregabalin•Identificare sintomi a carico del sistema sensoriale predittivi di riduzione dei punteggi del dolore nei soggetti trattati con QUTENZA•Valutare gli effetti di QUTENZA o pregabalin su intensità e area affetta da allodinia•Analizzare l' attenuazione del dolore e tollerabilità del trattamento sulla qualità di vita correlata alla salute mediante correlazione fra gli endpoint rilevanti
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are eligible for the study if all of the following apply: 1.Male or female between 18 and 80 years of age, inclusive 2.In good health as determined by the investigator 3.Documented diagnosis of probable or definite PNP [Treede et al, 2008] 4.Localized and well-defined area of PNP, suitable for treatment with QUTENZA 5.Documented diagnosis at the Baseline Visit of either: a.Postherpetic neuralgia (PHN) with pain persisting at least 6 months since shingles vesicle crusting b.Peripheral nerve injury (PNI) including post-surgical or post-traumatic neuropathic pain, persisting for a minimum of 3 months c.Non-diabetic painful peripheral polyneuropathy with pain which has persisted for a minimum of 3 months, including (i) small-fiber neuropathy, as confirmed by quantitative sensory testing (QST), laser evoked potentials (LEP) or skin biopsy, (ii) chemotherapy induced neuropathy in subjects with stable neoplastic disease, (iii) other, adequately characterized painful peripheral polyneuropathy, based on clinical history and examination 6.Average pain score ≥4 during Screening Period, over a minimum of at least 4 consecutive days (using the “average pain for the past 24 hours” Numeric Pain Rating Scale (NPRS) score 7.Intact, non-irritated, dry skin over the painful area(s) to be treated 8.Is either: a.Naïve to treatment with pregabalin and gabapentin, OR b.In the opinion of the investigator, has not received an adequate trial of treatment with pregabalin or gabapentin 9.Subject is willing to receive pregabalin or QUTENZA as part of the trial 10.Females of child bearing potential must be willing to use highly effective methods of birth control during the study and for 30 days following study termination (a highly effective method of birth control is defined as those which result in a low failure rate (CHMP/ICH/286/95 modified) of less that 1% per year when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices (IUDs), sexual abstinence or vasectomized partner) 11.Willing and able to comply with protocol requirements for the duration of study participation 12.Given written informed consent.
    Saranno considerati eleggibili per lo studio i soggetti che soddisfano tutti i seguenti criteri: 1.Soggetti di ambo i sessi e di età compresa tra 18 ed 80 anni (compresi) 2.Soggetti che a giudizio dello sperimentatore godono di buona salute 3.Diagnosi documentata di PNP probabile o certa [Treede et al, 2008] 4.Soggetti in cui l’area interessata da PNP è localizzata e ben definita, appropriata per il trattamento con QUTENZA 5.Diagnosi documentata alla Visita di Baseline di una delle seguenti condizioni: a.Nevralgia Posterpetica (PHN) con dolore che persiste da almeno 6 mesi dal momento in cui le vescicole erpetiche hanno formato la crosta b.Danno neuropatico periferico (PNI) compreso dolore neuropatico post-chirurgico oppure post-traumatico, che dura da almeno 3 mesi c.Polineuropatia periferica dolorosa non di origine diabetica ed associata a dolore che dura da almeno 3 mesi, fra cui (i) neuropatia delle piccole fibre, confermata da test quantitativo sensorio (QST), potenziali evocati laser (LEP) o biopsia cutanea, (ii) neuropatia secondaria a chemioterapia in soggetto con malattia neoplastica stabile, (iii) altra polineuropatia dolorosa periferica adeguatamente caratterizzata, in base all’anamnesi ed all’esame obiettivo 6.Punteggio medio del dolore ≥4 nel corso del Periodo di Screening, per un minimo di 4 giorni consecutivi (in base al punteggio del “dolore medio delle ultime 24 ore” alla scala NPRS (Numeric Pain Rating Scale) 7.Cute intatta, asciutta e priva di irritazioni nell’area/nelle aree da trattare 8.Soggetti che: a.Sono naïve rispetto al trattamento con pregabalin e gabapentin, OPPURE b.Soggetti che a giudizio dello sperimentatore non hanno ricevuto un adeguato trattamento con pregabalin o gabapentin 9.Soggetti che siano disponibili a ricevere pregabalin o QUTENZA nell’ambito dello studio 10.Le pazienti di sesso femminile in età fertile devono acconsentire ad utilizzare metodi contraccettivi altamente efficaci nel corso dello studio e per i 30 giorni successivi al termine dello stesso (si intendono altamente efficaci i metodi contraccettivi che si associano ad una bassa percentuale di insuccesso (criteri modificati CHMP/ICH/286/95) inferiore all’1% per anno quando utilizzati regolarmente ed in maniera corretta, ad esempio contraccettivi impiantabili, iniettabili, uso combinato di contraccettivi orali, alcuni dispositivi intrauterini (IUD), astinenza sessuale oppure partner vasectomizzato) 11.Soggetti disponibili e in grado di attenersi ai requisiti del protocollo per l'intera durata della propria partecipazione allo studio 12.Soggetti che hanno rilasciato per iscritto il consenso informato
    E.4Principal exclusion criteria
    Subjects will be excluded from this clinical study if any of the following apply: 1. Significant ongoing or recurrent pain of etiology other than PHN, PNI or non-diabetic painful peripheral polyneuropathy, for example: compression-related neuropathies (e.g. spinal stenosis), radiculopathy, tumor-related pain, fibromyalgia or arthritis 2. Complex Regional Pain Syndrome (CRPS, Type I or II) 3. Neuropathic pain related to previously administered radiotherapy, diabetes mellitus or HIV-AN 4. Neuropathic pain areas located only on the face, above the hairline of the scalp, and/or in proximity to mucous membranes 5. Severe loss of heat sensation in the painful area, indicative of C-fiber denervation 6. Reported daily pain score of 10 on the NPRS for at least 4 days during the Screening Period 7. Past or current history of diabetes mellitus 8. Unstable or poorly controlled hypertension or a recent history of a cardiovascular event which, in the opinion of the investigator, would put the subject at risk of adverse cardiovascular reactions related to the patch application procedure 9. Creatinine clearance (CLcr) < 60mL/min according to the Cockcroft-Gault formula 10. Untreated ongoing generalized anxiety disorder according to DSM-IV or ICD-10 criteria 11. Severe ongoing depression according to DSM-IV or ICD-10 criteria 12. Evidence of cognitive impairment including dementia that may interfere with subject’s ability to complete study evaluations and recall pain levels in the past 24 hours 13. Planned elective surgery during the trial 14. Changes to stable neuropathic pain background medication in the 4 weeks prior to the Baseline Visit 15. Any prior receipt of QUTENZA patches, including blinded patches administered as part of a clinical trial 16. Hypersensitivity to capsaicin (i.e., chilli peppers or Over-the-counter [OTC] capsaicin products), any QUTENZA excipients, local anesthetics, or adhesives 17. Treatment with pregabalin or gabapentin within 2 months prior to the Baseline Visit 18. Hypersensitivity to pregabalin or any of the excipients 19. Use of opioids exceeding a total daily dose of morphine of 200 mg/day, or equivalent; or any intravenous opioids or tapentadol, regardless of dose, within 7 days preceding the Baseline Visit 20. Use of any topical pain medication, such as non-steroidal anti-inflammatory drugs, menthol, methyl salicylate, local anesthetics (including patch containing lidocaine), steroids or capsaicin products on the painful areas to be treated within 7 days preceding the Baseline Visit 21. Chemotherapy within 3 months of the Baseline Visit, except maintenance hormone treatment 22. Use of any investigational agent within 30 days prior to Baseline Visit 23. Active substance abuse or history of chronic substance abuse within 1 year prior to screening; or any prior chronic substance abuse (including alcoholism) likely to re-occur during the study period as judged by the investigator 24. Female subjects of child-bearing potential with a positive serum or urine pregnancy test prior to treatment 25. Subject, who in the opinion of the investigator, is not suitable for the study for any reason.
    Saranno esclusi da questo studio clinico i soggetti che presentano qualsiasi dei seguenti criteri: 1. Dolore in atto o ricorrente di entità significativa e di eziologia diversa da PHN, PNI o polineuropatia dolorosa periferica non diabetica, fra cui: neuropatie da compressione (ad esempio stenosi spinale), radicolopatia, dolore oncologico, fibromialgia o artrite 2. Sindrome da Dolore Regionale Complesso (Complex Regional Pain Syndrome - CRPS, Tipo I o II) 3. Dolore neuropatico associato a pregressa radioterapia, diabete mellito oppure neuropatia HIV-correlata (HIV-AN) 4. L’area interessata dal dolore neuropatico è situata esclusivamente sul volto, sullo scalpo oltre l'attaccatura dei capelli, e/o in prossimità delle mucose 5. Perdita grave della percezione del calore nell'area interessata dal dolore, indicativa della denervazione delle fibre C 6. Punteggio riferito dal dolore giornaliero pari a 10 sulla scala NPRS per almeno 4 giorni durante il Periodo di Screening 7. Storia pregressa o attuale di diabete mellito 8. Ipertensione instabile o scarsamente controllata oppure storia recente di un evento cardiovascolare che, a giudizio dello sperimentatore, porrebbe il soggetto a rischio di reazioni cardiovascolari avverse a causa della procedura di applicazione del cerotto 9. Clearance della creatinina (CLcr) &lt; 60mL/min calcolata in base alla formula Cockcroft-Gault 10. Sindrome ansiosa generalizzata in corso e non trattata, secondo i criteri DSM-IV o ICD-10 11. Depressione grave in atto, secondo i criteri DSM-IV o ICD-10 12. Evidenza di compromissione cognitiva, compresa la demenza, tale da interferire con la capacità del soggetto di completare le valutazioni dello studio e di ricordare i livelli del dolore delle ultime 24 ore 13. Intervento chirurgico elettivo programmato durante il periodo dello studio 14. Modifiche del farmaco di background somministrato a dose stabile per il dolore neuropatico nelle 4 settimane precedenti la Visita di Baseline 15. Qualsiasi somministrazione precedente di cerotti QUTENZA, compresi cerotti applicati in cieco nell'ambito di uno studio clinico 16. Ipersensibilità alla capsaicina (ovvero al peperoncino piccante o prodotti a base di capsaicina vendibili senza ricetta medica [OTC]), a qualsiasi fra gli eccipienti di QUTENZA, ad anestetici locali oppure alle sostanze adesive 17. Trattamento con pregabalin o gabapentin nei 2 mesi precedenti la Visita di Baseline 18. Ipersensibilità a pregabalin oppure a qualsiasi dei suoi eccipienti 19. Uso di oppioidi in quantità superiore a un totale giornaliero di 200 mg/die di morfina o equivalente; oppure qualsiasi oppioide somministrato per via endovenosa o tapentadol, a prescindere dalla dose, nei 7 giorni precedenti la Visita di Baseline 20. Uso di qualsiasi farmaco analgesico topico, quale ad esempio un farmaco anti-infiammatorio non steroideo, mentolo, metilsalicilato, anestetici locali (compresi cerotti contenenti lidocaina), steroidi o prodotti a base di capsaicina sulle aree interessate dal dolore da trattare entro 7 giorni precedenti la Visita di Baseline 21. Chemioterapia nei 3 mesi precedenti la Visita di Baseline, ad eccezione del trattamento ormonale di mantenimento 22. Uso di qualsiasi agente sperimentale nei 30 giorni precedenti la Visita di Baseline 23. Abuso attuale di sostanze oppure storia di abuso cronico di sostanze nell’anno precedente lo screening; oppure qualsiasi pregresso abuso cronico di sostanze (compreso l’alcolismo) che a giudizio dello sperimentatore potrebbe rimanifestarsi nel periodo dello studio 24. Pazienti di sesso femminile in età fertile con risultato positivo al test di gravidanza su siero o su urine prima del trattamento 25. Soggetti che per qualsiasi motivo non sono ritenuti idonei per lo studio dallo sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in each arm who achieve at least a 30% decrease in the “average pain for the past 24 hours” NPRS score from baseline to Week 8
    Percentuale di soggetti in ciascun braccio con una riduzione alla Settimana 8 rispetto al baseline di almeno il 30% nel punteggio NPRS “dolore medio delle ultime 24 ore”
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 1-8
    settimana 1-8
    E.5.2Secondary end point(s)
    ● Proportion of subjects in each arm who achieve “optimal therapeutic effect” Optimal therapeutic effect is defined as: − No change in background chronic pain medication and no discontinuation of study drug due to lack of efficacy or tolerability prior to Week 8 − At least a 30% reduction in the “average pain for the past 24 hours” NPRS score, from baseline to Week 8, and − No moderate or severe adverse drug reactions (ADRs) during the stable Treatment Period ● Proportion of subjects who achieve at least a 30% decrease in the “average pain for the past 24 hours” NPRS score from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57), and complete 8 weeks of treatment ● Proportion of subjects who achieve at least a 50% decrease in the “average pain for the past 24 hours” NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Week 1 (Day 8) and Week 8 (Day 57), and complete 8 weeks of treatment ● Absolute and percent change in “average pain for the past 24 hours” NPRS score from baseline to Week 8, and from baseline to the mean of all scores recorded between Weeks 1 to 8 ● Time to onset of pain relief (in days) as assessed by at least a 30% reduction in “average pain for the past 24 hours” NPRS score ● Overall subject status using Patient Global Impression of Change (PGIC) questionnaire at Weeks 4 and 8 ● Change in the Medical Outcomes Study (MOS) 6-Item Cognitive Functioning Scale from baseline to Week 8 ● Change in the MOS – Sleep Scale from baseline to Weeks 4 and 8 ● Change in the EQ-5D-5L total score from baseline to Week 8 ● Treatment satisfaction as assessed by: − Proportion of subjects who discontinue study drug or withdraw from the study due to either a lack of efficacy or tolerability − Willingness to continue treatment at Week 8 − Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire at Week 4 and 8 ● Time to reach optimal maintenance dose for pregabalin ● Resource use (number of contacts with health professionals) ● Tolerability (assessed by the number, severity and duration of ADRs), collected as self-rated health-related complaints by the subject and then medically confirmed and causality assigned by the investigator ● Change in intensity and area of allodynia from baseline to Week 8 ● Changes in sensory symptoms between baseline and Week 8 assessed using Neuropathic Pain Symptom Inventory (NPSI) scores ● Reduction in pain by the pattern of sensory symptoms as defined using NPSI scores at baseline
    ● Percentuale di soggetti in ciascun braccio che ottengono `un effetto terapeutico ottimale` Per effetto terapeutico ottimale si intende: − Nessuna modifica del farmaco analgesico cronico di background e nessuna interruzione del farmaco sperimentale per motivi di mancata efficacia o problematiche di tollerabilità prima della Settimana 8 − Riduzione alla Settimana 8 rispetto al baseline di almeno il 30% del punteggio NPRS relativo al `dolore medio delle ultime 24 ore”, e − Assenza di reazioni avverse al farmaco (ADR) di entità moderata o grave durante il Periodo di Trattamento ● Percentuale di soggetti che ottengono una riduzione di almeno il 30% della media di tutti i punteggi NPRS relativi al “dolore medio delle ultime 24 ore` registrati fra la Settimana 1 (Giorno 8) e la Settimana 8 (Giorno 57) rispetto al baseline e che hanno completato le 8 settimane di trattamento ● Percentuale di soggetti che ottengono una riduzione di almeno il 50% del punteggio NPRS relativo al “dolore medio delle ultime 24 ore` alla Settimana 8 rispetto al baseline e della media di tutti i punteggi registrati fra la Settimana 1 (Giorno 8) e la Settimana 8 (Giorno 57) rispetto al baseline , e che hanno completato le 8 settimane di trattamento ● Variazione assoluta e percentuale alla Settimana 8 rispetto al baseline e variazione della media di tutti i punteggi registrati fra la Settimana 1 e la Settimana 8 rispetto al baseline del punteggio NPRS relativo al “dolore medio delle ultime 24 ore” ● Tempo necessario per raggiungere l`insorgenza dell`attenuazione del dolore (espresso in giorni) determinato in base ad almeno una riduzione del 30% del punteggio NPRS relativo al `dolore medio delle 24 ore appena passate` ● Stato globale del soggetto misurato in base al questionario Impressione Globale del Paziente - Cambiamento (Patient Global Impression of Change - PGIC) alla Settimana 4 e 8 ● Variazione alla Settimana 8 rispetto al baseline del punteggio della Scala MOS 6-Item Medical Outcomes Study Cognitive Functioning Scale ● Variazione alla Settimana 4 ed alla Settimana 8 rispetto al baseline nel punteggio della Scala MOS – Sleep ● Variazione alla Settimana 8 rispetto al baseline del punteggio totale EQ-5D-5L ● Soddisfazione rispetto al trattamento misurato in base a: − Percentuale di soggetti che interrompono il farmaco sperimentale o si ritirano dallo studio a causa di mancata efficacia oppure problemi di tollerabilità − Intenzione di continuare il trattamento alla Settimana 8 − Questionario della Soddisfazione rispetto al Trattamento TSQM (Treatment Satisfaction Questionnaire for Medication) alle Settimane 4 e 8 ● Tempo necessario per raggiungere la dose di mantenimento ottimale del pregabalin ● Utilizzo delle risorse (numero di contatti con operatori sanitari) ● Tollerabilità (valutata in base al numero, gravità e durata delle ADR), determinata raccogliendo le segnalazioni con autovalutazione delle problematiche relative alla salute riferite dal soggetto, successivamente confermate da giudizio medico e la cui correlazione di causalità viene stabilita dallo sperimentatore ● Variazione di intensità e dell’area interessata da allodinia alla Settimana 8 rispetto al baseline ● Variazione nei sintomi a carico del sistema sensoriale alla Settimana 8 rispetto al baseline determinata in base al punteggio NPSI (Neuropathic Pain Symptom Inventory) ● Riduzione del dolore in base all’andamento dei sintomi sensoriali utilizzando i punteggi NPSI registrati al baseline
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 1-8
    settimana 1-8
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    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 months14
    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.1.1Number of subjects for this age range: 0
    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: 263
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 263
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 526
    F.4.2.2In the whole clinical trial 526
    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)
    Qutenza and Pregabalin are authorized products in the Community, subjects may be prescribed the products by their physician if it is considered to be of benefit
    Qutenza e Pregabalin sono prodotti autorizzati nell'ambito della Comunità Europea, ai pazienti potranno essere prescritti i suddetti prodotti se considerati essere di beneficio
    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 Decision2012-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-26
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