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    Summary
    EudraCT Number:2015-002476-24
    Sponsor's Protocol Code Number:EP-DICLO-TIO/F-01-2015
    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:2015-07-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002476-24
    A.3Full title of the trial
    Randomized, double-blind, parallel-groups, active-controlled trial to evaluate the efficacy of a fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg as solution for injection, in improving back pain symptoms
    Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato verso farmaco attivo per valutare l’efficacia di una soluzione iniettabile a combinazione fissa di diclofenac 75 mg + tiocolchicoside 4 mg nel miglioramento dei sintomi dolorosi associati alla lombalgia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, double-blind, parallel-groups, active-controlled trial to evaluate the efficacy of a fixed combination of diclofenac 75 mg + thiocolchicoside 4 mg as solution for injection, in improving back pain symptoms
    Studio randomizzato, in doppio cieco, a gruppi paralleli, controllato verso farmaco attivo per valutare l’efficacia di una soluzione iniettabile a combinazione fissa di diclofenac 75 mg + tiocolchicoside 4 mg nel miglioramento dei sintomi dolorosi associati alla lombalgia.
    A.4.1Sponsor's protocol code numberEP-DICLO-TIO/F-01-2015
    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 SponsorEpifarma S.r.l.
    B.1.3.4CountryItaly
    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 supportEpifarma S.r.l.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEpifarma S.r.l.
    B.5.2Functional name of contact pointResponsabile Affari Regolatori
    B.5.3 Address:
    B.5.3.1Street AddressVia San Rocco, 6
    B.5.3.2Town/ cityEpiscopia ,Potenza
    B.5.3.3Post code85033
    B.5.3.4CountryItaly
    B.5.4Telephone number+390973655200
    B.5.5Fax number+390973655200
    B.5.6E-mailregolatorio@epifarma.it
    D. IMP Identification
    D.IMP: 1
    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 Voltaren®
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farma S.p.A.
    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.3.1Product nameVoltaren®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 Muscoril®
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis S.p.A.
    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.3.1Product nameMuscoril®
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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: 3
    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 namediclofenac 75 mg + tiocolchicoside 4 mg
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    low back pain
    lombalgia
    E.1.1.1Medical condition in easily understood language
    low back pain
    lombalgia
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10024891
    E.1.2Term Low back pain
    E.1.2System Organ Class 100000004859
    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 the trial is to compare the efficacy of Test and Active Control in improving pain symptoms in patients with acute moderate-severe low back pain (LBP) after 96 ± 2 hours of treatment. Efficacy will be determined by a 100-mm Visual Analogic Scale (VAS) assessment of pain. The VAS is a validated instrument for assessing degree of pain. It consists of a horizontal line, 100 mm in length, where patients put a vertical mark on the line indicating their current perception of pain.
    L’obiettivo primario dello studio è di comparare l’efficacia del farmaco test, rispetto al controllo attivo, nel miglioramento dei sintomi, in pazienti con lombalgia moderata o severa, dopo 96 ± 2 ore di trattamento. L’efficacia sarà determinata mediante l’utilizzo di una scala analogica visiva (VAS) di 100 mm, per la valutazione del dolore. La scala VAS è uno strumento validato per la valutazione del grado di dolore. Essa consiste in una linea orizzontale, lunga 100 mm, sulla quale il paziente pone un tratto verticale per indicare la percezione del dolore al momento dell’esecuzione del test.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to compare the efficacy of Test and Active control in:
    • Pain symptoms (VAS for pain) at all other time points over a treatment period of 5 days;
    • Spine stiffness (VAS for stiffness) at any time-point;
    • Time to resolution of pain;
    • Time to resolution of stiffness;
    • Consumption of rescue medication (paracetamol);
    • Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, laboratory evaluations, ECGs, and vital signs (sitting heart rate, sitting systolic/diastolic blood pressure, respiratory rate, body temperature).
    Gli obiettivi secondari dello studio sono comparare l’efficacia del farmaco test rispetto al controllo attivo in:
    • Sintomi dolorosi (VAS per la Valutazione del dolore) a tutti gli altri time points dello studio, in un periodo di trattamento di 5 giorni.
    • Rigidità del tronco (VAS per la Valutazione della rigidità) a ciascun time point dello studio.
    • Tempo di risoluzione della rigidità del tronco
    • Consumo di farmaco di soccorso (paracetamolo);
    • Tollerabilità e sicurezza dei farmaci di studio, valutate mediante la raccolta di eventi avversi, la frequenza di interruzione del trattamento dovuta ad eventi avversi, esami di laboratorio, ECGs e segni vitali (frequenza cardiaca a riposo, pressione sistolica e diastolica a riposo, frequenza respiratoria e temperatura corporea).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male and female patients aged 18-65 years;
    • Patients with acute LBP, defined as pain initiating from the area below the tips of the scapulae and above the buttocks, with onset no more than 7 days prior to the screening visit;
    • Back pain of moderate to severe intensity, defined as ≥ 50 mm at VAS;
    • If female and of child-bearing potential, the patient must be non-nursing and should not become pregnant throughout the whole study duration; all females of child-bearing potential must have a negative urine pregnancy test prior the first administration;
    • Satisfactory general health status as determined by the investigator based on medical history and physical examination;
    • Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial, and be willing to complete the required assessments.
    • Pazienti di entrambi i sessi con età compresa tra 18 e 65 anni;
    • Pazienti con lombalgia acuta, definita come dolore avvertito nella zona sottostante le punte delle scapole e sopra le natiche, con insorgenza non più di 7 giorni prima della visita di screening;
    • Dolore alla schiena (lombalgia) di intensità moderata o severa, definito da un valore riportato nella scala VAS ≥ 50 mm;
    • Le pazienti femminili in età fertile non dovranno allattare al seno e non dovranno intraprendere una gravidanza durante tutto il periodo di durata dello studio. Le pazienti femminili in età fertile dovranno sottoporsi ad un test di gravidanza su urine, che dovrà risultare negativo, prima della prima somministrazione del trattamento in studio.
    • Lo stato di salute generale del paziente deve essere considerato soddisfacente a giudizio dello sperimentatore, sulla base della storia medica del paziente e dell’esame fisico.
    • I pazienti devono comprendere e fornire il consenso informato scritto prima di poter partecipare allo studio. Essi devono pienamente comprendere le procedure di studio previste e devono essere ritenuti in grado di completare tutte le valutazioni richieste.
    E.4Principal exclusion criteria
    • Patients unwilling to give an informed consent approval;
    • Patients with a history of cervical, thoracic, or lumbosacral pain for ≥ 50% of the time in the year prior to screening;
    • Patients with presence of lumbosciatalgia;
    • Patients with a history of any LBP episode, except the current acute episode, within 3 months prior to screening that was associated with disability, or required treatment with an opioid analgesic;
    • Patients with acute LBP caused by a serious or malignant condition;
    • Patients with acute LBP of traumatic origin;
    • Patients on treatment with anticoagulant agents;
    • Patients who underwent spinal surgery in the year prior to screening or had a history of more than one spinal surgery;
    • Patients who had a history of severe lumbar spinal stenosis, fibromyalgia, or ankylosing spondylitis;
    • Patients with a medical history of seizures;
    • Pregnancy or lactation period;
    • Women with childbearing potential who are not using adequate methods to avoid pregnancy;
    • Women with polymenorrhea;
    • History of alcohol or drug abuse;
    • History of allergy or hypersensitivity or intolerance to diclofenac or thiocolchicoside, and/or to active or inactive excipients of the used investigational study products (IMPs) formulations;
    • Known hypersensitivity to non-steroidal anti-inflammatory drugs (NSAIDs), and in particular to paracetamol;
    • Use of non-steroid anti-inflammatory drugs (e.g. acetyl salicylic acid) and analgesics (with the exception of paracetamol) in the week before the study. Chronic intake of small doses of acetylsalicylic acid (≤ 162 mg/daily) taken for at least 30 days prior to the first dose of study medication for non-analgesic reasons may be continued for the duration of the study;
    • Use of any other treatment or medication that can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) for the same indication or other indications (e.g. rheumatoid arthritis); in the week before the study.
    • History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening;
    • History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results;
    • Participation in any other clinical study within 30 days prior to the screening.
    • Pazienti che non hanno fornito il consenso informato scritto.
    • Pazienti con storia di dolore cervicale, toracico o lombosacrale per ≥ 50% del tempo, nell’anno precedente all’inclusione;
    • Pazienti con lombosciatalgia;
    • Pazienti con storia di qualsiasi precedente episodio di lombalgia, eccetto l’episodio corrente, nei 3 mesi precedenti lo studio, che fosse associato a disabilità o che abbia richiesto un trattamento con analgesici oppioidi.
    • Pazienti con lombalgia acuta causata da altre condizioni gravi o maligne.
    • Pazienti con lombalgia acuta di origine traumatica;
    • Pazienti in trattamento con anticoagulanti orali;
    • Pazienti che sono stati sottoposti ad interventi chirurgici spinali nell’anno precedente l’inclusione Nello studio o pazienti che hanno una storia clinica di più di un intervento spinale;
    • Pazienti con storia di stenosi spinale lombare grave, stenosi spinale, fibromialgia o spondilite anchilostante;
    • Pazienti con storia di epilessia;
    • Donne in gravidanza o allattamento;
    • Donne in età fertile che non utilizzino un adeguato metodo di contraccezione;
    • Donne con storia di polimenorrea
    • Storia di abuso di alcool o droghe;
    • Storia di allergia o ipersensibilità o intolleranza a diclofenac o thiocolchicoside, e/o agli eccipienti attivi o inattivi delle formulazioni dei prodotti in studio;
    • Nota ipersensibilità agli antiinfiammatori non steroidei e in particolare al paracetamolo;
    • Uso di farmaci antiinfiammatori non steroidei (es. acido acetilsalicilico) e analgesici (ad eccezione del paracetamolo) nella settimana precedente lo studio. L’assunzione cronica di piccolo dosi di acido acetilsalicilico (≤ 162 mg/ giorno) se preso da almeno 30 giorni prima della prima somministrazione del farmaco in studio per ragioni non analgesiche potrà essere continuata per tutta la durata dello studio;
    • Utilizzo di qualsiasi altro trattamento o medicazione che possa alterare la percezione del dolore (es. eparinici, oppioidi, agenti psicotropi, agenti anti H1 o analgesici come glucocorticosteroidi, FANS, ecc.) per la stessa indicazione o per altre indicazioni (es. artrite reumatoide) nella settimana precedente lo studio.
    • Storia di ulcere o sanguinamenti esofagei, gastrici, duodenali o del canale pilorico, attivi o sospetti, nei 30 giorni precedenti lo screening;
    • Storia di patologie concomitanti acute o croniche non controllate, che a giudizio dello sperimentatore, possano controindicare la partecipazione del paziente allo studio o alterarne l’interpretazione dei risultati.
    • Partecipazione ad altri trial clinici nei 30 giorni precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable of the study will be the change from baseline in VAS score at rest 96 ± 2 hours after treatment start. This will be the VAS value measured at the investigational study site at Visit 5 (Day 5), one hour after receiving the last IMP administration.
    La variabile primaria di efficacia dello studio sarà la variazione rispetto al basale del punteggio VAS a 96 ± 2 ore dopo l'inizio del trattamento. Il valore di VAS a 96 ± 2 ore sarà il valore VAS misurato presso il centro di sperimentazione alla Visita 5 (5° giorno), un'ora dopo la ricezione dell'ultima dose di farmaco
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy variable of the study will be the change from baseline at 96 ± 2 hours after treatment start.
    La variabile primaria di efficacia dello studio sarà la variazione rispetto al basale del punteggio ottenuto a 96 ± 2 ore dopo l'inizio del trattamento.
    E.5.2Secondary end point(s)
    Secondary efficacy variables
    • VAS for pain at rest at the other time points over a treatment period of 5 days;
    • Spine stiffness (VAS for stiffness) at any time-point;
    • Time to resolution of pain;
    • Time to resolution of stiffness;
    • Consumption of rescue medication (paracetamol);
    Safety variables
    • Summaries of adverse events and frequency of discontinuation of treatment due to adverse events
    • Laboratory evaluations;
    • ECG;
    • Vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature).
    Variabili secondarie di efficacia
    • VAS per il dolore a tutti gli altri time point, in un periodo di trattamento di 5 giorni.
    • Rigidità del tronco (VAS per la rigidità) a ciascun time point
    • Tempo di risoluzione del dolore;
    • Tempo di risoluzione della rigidità;
    • Consumo di farmaco di soccorso (paracetamolo)
    Variabili di sicurezza
    • raccolta di eventi avversi e frequenza di interruzione del trattamento dovuta ad eventi avversi
    • esami di laboratorio
    • ECG
    • segni vitali (frequenza cardiaca a riposo, pressione sistolica e diastolica a riposo, frequenza respiratoria e temperatura corporea).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Laboratory tests and ECG will be performed at baseline and at the final visit.
    All other variables will be evaluated at each study visit.
    Vital signs will be collected at all study visits, prior the administration of the study drug and one hour after injection.
    Gli esami di laboratorio e gli ECG saranno effettuati alla visita iniziale e alla visita finale.
    Tutte le altre variabili saranno valutate ad ogni visita dello studio.
    I segni vitali saranno raccolti a tutte le visite dello studio, prima della somministrazione del farmaco in studio e un'ora dopo l'iniezione.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 concerned20
    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
    LSLV
    Ultima visita ultimo soggetti
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 240
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 240
    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 state240
    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)
    At the end of the study, the investigator will decide the most appropriate therapy for the treatment of each patient
    Al termine dello studio il medico sperimentatore deciderà l'eventuale terapia che riterrà più opportuna per la cura di ciascun paziente
    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 Decision2015-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-13
    P. End of Trial
    P.End of Trial StatusCompleted
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