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    Summary
    EudraCT Number:2011-002743-10
    Sponsor's Protocol Code Number:A0081268
    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:2012-03-02
    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 number2011-002743-10
    A.3Full title of the trial
    A study of pregabalin in the treatment of subjects with painful diabetic peripheral neuropathy with background treatment of NSAID for other pain condition.
    Studio su Pregabalin nel trattamento di soggetti affetti da neuropatia diabetica periferica dolorosa sottoposti a terapia di background con FANS per altra condizione dolorosa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Test the Effectiveness of Pregabalin in Relieving Symptoms of Patients with Diabetic Peripheral Neoropathy who also Uses an Anti-Inflammatory Drug for Another Condition.
    Studio per testare la efficacia del pregabalin nell'alleviare i sintomi in Pazienti con neuropatia diabetica periferica che usano anche farmaci antinfiammatori per un'altra condizione.
    A.3.2Name or abbreviated title of the trial where available
    Pregabalin used with NSAIDs for treatment of DPN.
    Pregabalin usato con FANSs per il trattam di DPN
    A.4.1Sponsor's protocol code numberA0081268
    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 SponsorPFIZER INC.
    B.1.3.4CountryUnited States
    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 supportPfizer Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryItaly
    B.5.4Telephone number001 8007181021
    B.5.5Fax number001 303 739 1119
    B.5.6E-mailclinicaltrials.govcallcentre@pfizer.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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited,Ramsgate Road,Sandwich,Kent, CT13 9NJ UK
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.9.2Current sponsor codePD-144,723
    D.3.9.3Other descriptive nameNA
    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 number50
    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 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,Ramsgate Road, Sandwich,Kent CT13 9NJ,UK
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.9.2Current sponsor codePFD-144,723
    D.3.9.3Other descriptive nameNA
    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 number100
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    painful diabetic peripheral neuropathy
    dolore neuropatico diabetico
    E.1.1.1Medical condition in easily understood language
    la neuropatia diabetica periferica è un disturbo del nervo periferico a volte causato dal diabete
    DPN is a peripheral nerve disporder sometimes caused by diabetes.
    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 10012683
    E.1.2Term Diabetic peripheral neuropathy
    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 evaluate the efficacy of pregabalin compared with placebo for the symptomatic relief of DPN pain in subjects with painful DPN who use one NSAID (including COX-2 inhibitors) primarily for the treatment of conditions other than DPN pain.
    Valutare l'efficacia di pregabalin rispetto al placebo per il sollievo sintomatico del dolore da neuropatia diabetica periferica in soggetti con neuropatia diabetica periferica dolorosa che utilizzano un FANS (compresi gli inibitori della COX-2) principalmente per il trattamento di condizioni diverse dal dolore neuropatico diabetico periferico dolorosa.
    E.2.2Secondary objectives of the trial
    1)To evaluate the efficacy of pregabalin compared with placebo treatment to improve subject global assessment, sleep, quality of life associated with DPN, and time to loss of pain response. 2)To evaluate the safety and tolerability of pregabalin.
    •Valutare l'efficacia di pregabalin rispetto al placebo per migliorare la valutazione globale del soggetto, il sonno, la qualità della vita correlata alla neuropatia diabetica periferica e il tempo alla perdita della risposta al dolore. •Valutare la sicurezza e la tollerabilità di pregabalin.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis of type 1 or 2 diabetes mellitus with current hemoglobin A1C levels of 11%. Subject is to be on an antidiabetic treatment regimen and it must be stable for the 30 days prior to Visit 2. 2. Diagnosis of painful, diabetic distal symmetrical sensorimotor polyneuropathy for at least 3 months (refer to Appendix 1 for diagnostic worksheet). 3. Currently treated with one NSAID (including COX-2 inhibitors) for a co-morbid pain condition with a regular dose (4 days/week) for at least 4 weeks prior to screening, and the ability to maintain the same treatment regimen during the study. The NSAID use must not be primarily for treating the subject's DPN pain. 4. Meet the following 2 criteria demonstrating inadequate pain control:  A score of 4 on the one-week recall, 11-point numerical rating scale for pain (Weekly-NRS Pain) at screening, Visit 1.  AND at Visit 2, subjects must have completed at least 4 daily pain diaries over the past 7 days (baseline) and have an average daily pain score of 4 on the 11-point numeric rating scale for pain (Pain Diary). 5. Men or women who are at least 18 years of age. 6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. 090177e1822933c3\Approved\Approved On: 26-Jul-2011 16:54 Pregabalin A0081268 Final Protocol, 22 July 2011 PFIZER CONFIDENTIAL Page 15 of 79 7. Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study. 8. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures including the training and completion of the daily pain and sleep diaries using IVRS.
    1. Diagnosi di diabete mellito di tipo 1 o 2 con gli attuali livelli di emoglobina A1C  11%. Il soggetto deve essere in un regime di trattamento antidiabetico ed esso deve essere stabile nei 30 giorni precedenti la Visita 2. 2. Diagnosi di polineuropatia diabetica sensitivo-motoria distale simmetrica dolorosa da almeno 3 mesi. 3. Attualmente in trattamento con un FANS (compresi gli inibitori della COX-2) per una condizione dolorosa di comorbilità ad una dose regolare ( 4 giorni/settimana) per almeno 4 settimane prima dello screening, e capacità di mantenere lo stesso regime di trattamento durante lo studio. L'uso di FANS non deve essere dovuto principalmente al trattamento del dolore da DPN del soggetto. 4. Soddisfare i 2 criteri seguenti che dimostrano controllo inadeguato del dolore: • Un punteggio 4 per il richiamo ad una settimana nella scala di valutazione numerica di 11 punti per il dolore (NRS del dolore settimanale) allo Screening, Visita1. • E alla Visita 2, i soggetti devono aver compilato almeno 4 diari giornalieri del dolore negli ultimi 7 giorni (basale) ed avere un punteggio del dolore quotidiano 4 sulla scala di valutazione numerica del dolore di 11 punti (Diario del Dolore). 5. Soggetti di sesso maschile o femminile di almeno 18 anni di età. 6. I soggetti di sesso maschile o femminile potenzialmente fertili devono accettare di utilizzare un metodo contraccettivo altamente efficace nel corso dello studio e per almeno 28 giorni dopo l’ultima somministrazione del trattamento assegnato. Un soggetto è in età fertile se, a giudizio dello sperimentatore, è biologicamente in grado di avere figli ed è sessualmente attivo. 7. La prova di un documento di consenso informato firmato e datato personalmente per indicare che il soggetto è stato informato di tutti gli aspetti relativi allo studio. 8. Soggetti disposti a e in grado di rispettare le visite programmate, lo schema di trattamento, gli esami di laboratorio e le altre procedure di studio, compresi il training e la compilazione dei diari del dolore quotidiano e del sonno tramite l’IVRS.
    E.4Principal exclusion criteria
    Pain fluctuation >/=4 points determined by the difference between the highest and lowest pain score by Pain Diary during baseline period (the last 7 days prior to V2). 2. Have failed pregabalin treatment due to lack of efficacy at therapeutic dose(s), have intolerance to pregabalin or any pregabalin ingredient, have used pregabalin within the last 30 days (prior to V1). Note: If the subject has taken pregabalin and discontinued for reasons other than lack of efficacy or intolerance (eg, economic burden), then they will be eligible. 3. Participated in a previous or ongoing pregabalin clinical trial. 4. Neurologic disorders unrelated to diabetic neuropathy that may confound the assessment of distal neuropathic pain. 5. Skin conditions in the area affected by the neuropathy that could alter sensation. 6. Other pain conditions (such as low back pain, osteoarthritis pain) that may confound the assessment or self-evaluation of the pain due to DPN. 7. Clinically significant unstable diabetes mellitus, or unstable hepatic, respiratory, or hematologic illnesses, unstable cardiovascular disease (including a myocardial infarction in the 3 months prior to V1), or symptomatic (painful) peripheral vascular disease. 8. Amputations due to diabetic complications of body parts other than toes. 9. History or current evidence of any condition that could lead to impaired absorption of vitamin B12 (pernicious anemia, chronic gastritis of any cause, surgery such as gastrectomy or gastric bypass surgery, etc.) 10. Untreated hypothyroidism, chronic hepatitis B, hepatitis B within the past 3 months, or known HIV infection. 11. Have had a malignancy other than basal cell carcinoma or carcinoma in situ of the cervix within the past 5 years. 12. Have creatinine clearance (CLcr) < 60 mL/min (estimated prior to Visit 2 from serum creatinine obtained at Visit 1, body weight, age, and gender using the Cockcroft and Gault equation; see Section 7). Subjects who have an estimated CLcr <60 mL/min by this screening method may have their CLcr measured, at the investigator’s discretion, with a 24-hour urine collection performed at the central laboratory. If this 24-hour urine CLcr is 60 mL/min, the subject is not excluded on the basis of this criterion. 13. Clinically significant abnormal electrocardiogram (ECG) by the Investigators' discretion. 14. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 15. Use of prohibited concomitant meds which cannot be safely washed out prior to study participation. These medications include but are not limit to: those used to relieve neuropathic pain (other than underlying NSAIDs); antiepileptics (including gabapentin); antidepressants. Note: SSRIs for managing depression and/or anxiety are allowed if stable >30 days and can be maintained without change during the study. 16. Currently receiving pregabalin or opioids (other than tramadol) for painful DPN. 17. Participation in other studies in the 30 days before the current study begins and/or during study participation. 18. Any subject considered at risk of suicide or self harm based on investigator judgment.
    1. Fluttuazione del dolore  4 punti determinata dalla differenza tra il punteggio del dolore più alto e quello più basso nel diario del dolore durante il periodo del basale (ultimi 7 giorni prima della V2). 2. Fallimento del trattamento con pregabalin a causa della mancanza di efficacia con la/le dose/i terapeutica/che, intolleranza al pregabalin o a qualsiasi ingrediente del pregabalin, assunzione di pregabalin negli ultimi 30 giorni (prima della V1). Attenzione: Se il soggetto ha assunto pregabalin e lo ha sospeso per ragioni diverse dalla mancanza di efficacia (ad esempio, costi) potrà essere considerato idoneo. 3. Partecipazione a sperimentazione clinica precedente o in corso con pregabalin. 4. Patologie neurologiche non correlate a neuropatia diabetica che possono confondere la valutazione del dolore neuropatico distale. 5. Patologie cutanee nella zona interessata dalla neuropatia che potrebbero alterare la sensibilità. 6. Altre condizioni di dolore (come mal di schiena, dolori da artrosi) che possono confondere la valutazione e autovalutazione del dolore a causa della DPN. 7. A livello clinicamente significativo, diabete mellito instabile; patologie epatiche, respiratorie o ematologiche instabili; patologie cardiache instabili (compreso infarto miocardico nei 3 mesi precedenti la V1) ; o patologia vascolare periferica sintomatica (dolorosa) 8. Amputazioni dovute a complicanze diabetiche di parti del corpo diverse dalle dita dei piedi. 9. Storia o evidenza di qualsiasi condizione che potrebbe portare a un ridotto assorbimento di vitamina B12 (anemia perniciosa, gastrite cronica di qualsiasi origine, interventi chirurgici come gastrectomia o di bypass gastrico, ecc.) 10. Ipotiroidismo non trattato, epatite B cronica, epatite B negli ultimi 3 mesi o l'infezione da HIV nota. 11. Neoplasia diversa da carcinoma a cellule basali o carcinoma in situ della cervice negli ultimi 5 anni. 12. Clearance della creatinina (CLcr) &lt;60 ml/min (stimato prima della Visita 2 dalla creatinina sierica rilevata nella Visita 1, peso corporeo, età e sesso, utilizzando l’equazione di Cockcroft e Gault. Con questo metodo di screening, i soggetti con una clearance della creatinina stimata &lt;60 ml/min possono avere una misurazione della propria CLcr, a discrezione dello sperimentatore, tramite una raccolta delle urine delle 24 ore effettuata presso il laboratorio centrale. Se tale CLcr delle urine delle 24 ore è  60 ml/min, il soggetto non viene escluso, sulla base di questo criterio. 13. Elettrocardiogramma (ECG) anormale clinicamente significativo a discrezione dello sperimentatore. 14. Altri gravi patologie mediche o psichiatriche acute o croniche o anormalità di laboratorio che possono aumentare il rischio associato con la partecipazione allo studio o alla somministrazione del farmaco di studio o che possono interferire con l'interpretazione dei risultati dello studio e, a giudizio dello sperimentatore, renderebbero il soggetto non idoneo per l’inclusione nello studio. 15. Uso concomitante di farmaci non consentiti che non possono subire un processo di washout con sicurezza prima della partecipazione allo studio. Questi farmaci comprendono, ma non si limitano a: farmaci utilizzati per alleviare il dolore neuropatico (diversi dal FANS di fondo); antiepilettici (compreso gabapentin); antidepressivi. Attenzione: Gli SSRI per la gestione di depressione e/o ansia sono consentiti se stabili per &gt; 30 giorni e possono essere mantenuti senza modifiche durante lo studio. 16. Somministrazione in corso di pregabalin o oppioidi (diversi dal tamadolo) per la DPN dolora. 17. Partecipazione ad altri studi nei 30 giorni precedenti l’inizio del presente studio e/o durante la partecipazione allo studio. 18. Qualsiasi soggetto considerato a rischio di suicidio o di autolesioni secondo il giudizio dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    Endpoint mean pain score, based on the mean of the last 7 daily pain numeric rating scale (NRS) scores from the daily pain diaries while receiving study medication in each treatment period (eg, daily pain diary (0-10 numeric rating scale)).
    • Endpoint del punteggio medio del dolore, basato sulla media degli ultimi 7 punteggi del dolore quotidiano nella scala di valutazione numerica (NRS) all’interno dei diari giornalieri del dolore durante la somministrazione del farmaco di studio in ciascun periodo di trattamento (ad esempio, il diario giornaliero del dolore (scala di valutazione numerica 0-10)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Reduction in DPN pain, as from the daily pain diaries while receiving study medication in each treatment period (V2-V6 & V7-V11)
    Riduzione nel dolore neuropatico diabetico come riportato nei diario giornaliero del dolore durante l'assunzione del farmaco in studio in ogni periodo di trattamento (V2-V6 & V7-V11)
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints  Proportions of >/=30% and >/=50% pain responders using NRS scores from the daily pain diary (Pain Diary).  Patient Global Impression of Change assessed at the end of Period 1 (PGIC).  Daily Sleep Interference Rating Scale (Sleep Diary).  Quality of life using Norfolk Quality of Life Questionnaire – Diabetic Neuropathy (QoL-DN).  European Quality of Life in 5 Dimensions (EQ-5D).  Pain severity and impact using the Brief Pain Inventory – short form (BPI-sf).  Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS). Exploratory Efficacy Endpoints  Patient Global Impression of Change assessed at the end of Period 2 (PGIC).  Patient Static Global Assessment (PSGA).  The relationship between PGIC and PSGA.
    Endpoint secondari di efficacia •Percentuali ≥ 30% e ≥ 50% di pazienti che rispondono al dolore utilizzando i punteggi NRS dal diario del dolore giornaliero (Diario del Dolore). •Patient Global Impression of Change (PGIC) valutata al termine del Periodo 1. •Scala del Daily Sleep Interference Rating (Diario del Sonno). •Qualità della vita utilizzando il questionario di Norfolk sulla Qualità di Vita - Neuropatia Diabetica (QoL-DN). •Questionario European Quality of Life in 5 Dimensions (EQ-5D). •Severità e impatto del dolore utilizzando il Questionario Brief Pain Inventory – short form (BPI-sf). •Ansia e depressione utilizzando la Hospital Anxiety and Depression Scale (HADS). Endpoint di efficacia esplorativi •Patient Global Impression of Change (PGIC) valutata al termine del Periodo. •Patient Static Global Assessment (PSGA). •Correlazione tra PGIC e PSGA
    E.5.2.1Timepoint(s) of evaluation of this end point
    Responde rate based on 30% and 50% improvment in mean pain response from daily pain diary) (V2-V6 & V7-V11); -Brief Pain Inventory-short form (BP-sf) -V2 ,V6/ET & V11/ET; -Norfolk Quality of Life Questionnaire for Diabetic Neuropathy (QOL-DN) modified with 2 week recall (V2,V6/ET & V11/ET) -Sleep Interference Rating Scale (daily sleep diary) V1-V12; -Hospital Anxiety and Depression Scale (HADS) V2,V6/ET, & V11/ET; Euro QoL-5 Dimension (EQ-5D) V2,V6/ET & V11/ET.
    •Tasso di risposta in base al 30% e 50% del miglioramento nella principale risposta al dolore ( dal diario del dolore giornaliero (Diario del Dolore) V2-V6 & V7-V11); .Brief Pain Inventory-short form (BP-sf) -V2 ,V6/ET & V11/ET; •Qualità della vita utilizzando il questionario di Norfolk sulla Qualità di Vita - Neuropatia Diabetica (QoL-DN) (V2,V6/ET & V11/ET); •Patient Global Impression of Change (PGIC) valutata al termine del Periodo 1 confrontata con l'inizio del trattamento (V6/ET, & V11/ET); •Scala del Daily Sleep Interference Rating (Diario del Sonno) V1-V12; •Ansia e depressione utilizzando la Hospital Anxiety and Depression Scale (HADS) V2,V6/ET, & V11/ET; •Questionario European Quality of Life in 5 Dimensions (EQ-5D) V2,V6/ET & V11/ET.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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
    Tolerability
    Tollerabilità
    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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    South Africa
    United States
    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 months17
    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 months17
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 200
    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)
    as per protocol
    in accordo al Protocollo
    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 Decision2012-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-22
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