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    Summary
    EudraCT Number:2012-005030-11
    Sponsor's Protocol Code Number:12I-BMT08
    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:2013-01-11
    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 number2012-005030-11
    A.3Full title of the trial
    Multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of two different treatment regimens of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic tendinopathies of the upper and lower limbs
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, volto a valutare l’efficacia e la sicurezza a breve termine di due diversi regimi di trattamento con cerotto medicato contenente betametasone valerato 2.25 mg in pazienti con tendinopatie croniche agli arti superiori e inferiori
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the short-term efficacy and safety of two different treatment regimens of Betamethasone valerate 2.25 mg medicated plaster in patients with chronic tendinopathies of the upper and lower limbs
    Studio multicentrico, randomizzato, in doppio cieco, controllato verso placebo, volto a valutare l’efficacia e la sicurezza a breve termine di due diversi regimi di trattamento con cerotto medicato contenente betametasone valerato 2.25 mg in pazienti con tendinopatie croniche agli arti superiori e inferiori
    A.4.1Sponsor's protocol code number12I-BMT08
    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 SponsorIBSA INSTITUT BIOCHIMIQUE SA
    B.1.3.4CountrySwitzerland
    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 supportIBSA Institut Biochimique SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIBSA Institut Biochimique SA
    B.5.2Functional name of contact pointR&D Dept.
    B.5.3 Address:
    B.5.3.1Street AddressVia del Piano
    B.5.3.2Town/ cityPambio-Noranco
    B.5.3.3Post code6915
    B.5.3.4CountryItaly
    B.5.4Telephone number+41 (0) 58 360 16 31
    B.5.5Fax number+41 (0) 58 360 16 55
    B.5.6E-mailstefano.rovati@ibsa.ch
    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 BETESIL*4CER MED 2,250MG
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI 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 Cutaneous patch
    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 INNBETAMETHASONE VALERATE
    D.3.9.1CAS number 2152-44-5
    D.3.9.4EV Substance CodeSUB00786MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.25
    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 typecorticosteroide
    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 placeboCutaneous patch
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Lateral Elbow Tendinopathy and Chronic Midportion (or non-insertional) Achilles Tendinopathy
    Tendinopatia cronica laterale del gomito e Tendinopatia cronica della porzione mediale (o non inserzionale) del tendine di Achille
    E.1.1.1Medical condition in easily understood language
    Tennis elbow and Achilles tendonitis
    gomito del tennista e tendinite d'Achille
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10050471
    E.1.2Term Achilles tendon pain
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10043258
    E.1.2Term Tennis elbow
    E.1.2System Organ Class 100000004863
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10000441
    E.1.2Term Achilles tendonitis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10024032
    E.1.2Term Lateral epicondylitis
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to investigate the ability of betamethasone valerate 2.25 mg medicated plaster, as compared to placebo plaster (same formulation but without active ingredient), to reduce pain when topically applied daily, according to two different dose regimens (i.e., 12 or 24 hours of application/day), and during a period of 4 weeks, in patients suffering from chronic lateral elbow tendinopathy and chronic midportion Achilles tendinopathy.
    Obiettivo principale dello studio: valutare l’efficacia del cerotto medicato contenente 2.25 mg di betametasone valerato, rispetto al placebo (stessa formulazione ma senza principio attivo) nel ridurre il dolore quando applicato localmente quotidianamente, secondo due diversi regimi di trattamento (12 o 24 ore di applicazione/giorno), e per un periodo di 4 settimane, in pazienti affetti da tendinopatia cronica laterale del gomito e tendinopatia cronica della porzione mediana del tendine di Achille
    E.2.2Secondary objectives of the trial
    Secondary objectives of the study are the evaluation of the local tolerability at the site of plaster application, with particular attention to any atrophic change of the skin, and the appreciation of the general safety of the tested medication.
    Obiettivi secondari dello studio sono la valutazione della tollerabilità locale nel sito di applicazione del cerotto, con particolare attenzione a qualsiasi cambiamento atrofico della pelle, e la valutazione della sicurezza generale del cerotto in studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects (outpatients) of both gender, aged ≥18 years 2. suffering ≥12 weeks either from Chronic Lateral Elbow Tendinopathy (MedDRA version 15.1, LLT Classification code: 10024032 = Lateral epicondylitis; 10043258 = Tennis elbow) or Chronic Midportion (or non-insertional) Achilles Tendinopathy (MedDRA version 15.1, LLT Classification code: 10000441 = Achilles tendonitis; 10050471 = Achilles tendon pain), being confirmed through an ultrasound echographic scan, will be screened for participation. 3. Patients should be in their symptomatic phase, defined as a pain ≥50 mm on a 0-100 mm Visual Analogue Scale as perceived when performing a standardized movement, identified as the most painful one according to the tendinopathy localisation 4. Patient should have given a valid written informed consent to participate in the study. 5. Female subjects of childbearing potential (i.e., not status post hysterectomy or tubal ligation) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline.
    1. pazienti ambulatoriali di entrambi i sessi, età ≥18 anni; 2. pazienti che soffrono da un periodo ≥ 12 settimane di Tendinopatia cronica laterale del gomito (MedDRA versione 15.1, LLT codice di classificazione: 10024032 = Epicondilite Laterale; 10043258 = gomito del tennista) o Tendinopatia cronica della porzione mediale (o non inserzionale) del tendine di Achille (MedDRA versione 15.1, LLT codice di classificazione: 10000441 = Tendinite di Achille; 10050471 = Dolore al tendine di Achille), confermata da una scansione ecografica ad ultrasuoni; 3. pazienti in fase sintomatica del dolore, definita come una percezione del dolore ≥ 50 mm in una scala VAS 0-100 mm, durante l’esecuzione di un movimento standardizzato definito come il più doloroso in accordo alla localizzazione della tendinopatia; 4. firma del consenso informato a partecipare allo studio; 5. donne in età fertile (che non abbiano subito un intervento di isterectomia o di legamento delle tube) dovranno utilizzare un appropriato metodo contraccettivo in accordo alla Nota 3 delle Guideline ICH M3.
    E.4Principal exclusion criteria
    1. patients with chronic insertional Achilles tendinopathy; 2. patients having received a local corticosteroid injection for their tendinopathy or an intra-articular corticosteroid injection <6 months before inclusion; 3. patients having undergone a standard physiotherapeutic treatment (except for cold or hot patch application and/or use of braces for casting), an electro-medical Tecar therapy, a Laser therapy, Iontophoresis therapy or Eccentric Training for the treatment of their tendinopathy <3 months before inclusion; 4. patients having taken systemic anti-inflammatory steroidal drugs or having received local corticosteroid injection for medical conditions other than the one under investigation <1 months before inclusion; patients having taken systemic NSAIDs (e.g. ibuprofen, ketoprofen) <48 hours (paracetamol permitted), or long-acting NSAIDs (piroxicam or naproxen), opioids and narcotic analgesics <7 days before inclusion, or patients under chronic treatment with topical or systemic analgesics/NSAIDs; 5. patients presenting signs and symptoms suggestive of another cause for their pain, congenital or acquired structural or neurological abnormalities of the limb area, chronic joint diseases, possible traumatic or neoplastic origin of symptoms, bilateral complaints, referred pain from internal organs, previous surgical treatment on the limb area (or surgical treatment planned in the 6 weeks following the inclusion); 6. patients having fractures, dislocations, calcifications or ruptures of tendon in the affected limb area (the presence of these conditions should be investigated by ultrasonography (US) examination at inclusion visit); 7. patients with history of previous fractures or ruptures of tendon in the affected limb area; 8. patients with systemic musculoskeletal disease or neurological disorder; 9. patients with presence of skin lesions or dermatological diseases that could interfere with the application of the plaster (e.g. dermatitis, skin ulcers, burns, skin infections, skin atrophy). 10. allergy to the active substance or excipients contained in the tested medication or to the rescue medication (paracetamol); 11. underlying disease or medication that severely compromise the subject's immune system 12. history of anaphylaxis to drugs or allergic reactions in general which the Investigator considers to potentially affect the outcome of the study; 13. presence of severe cardiac, liver or kidney dysfunction; 14. pregnant or breast-feeding women; 15. concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs during 3 months before this study or previous participation in the same study; 16. patients unable to comprehend the full nature and the purpose of the study, including possible risks and side effects, because of psycho-social or other reasons, and patients unable to cooperate with the Investigator and to comply with the requirement of the entire study (including inability to attend all the planned study visits according to the time limits); 17. patients with history of alcohol or drug abuse (within previous 12 months); 18. patients with clinically significant or unstable concurrent disease whose sequelae or treatment might interfere with the study evaluation parameters; 19. patients with metabolic or other diseases like malignancy and major psychiatric disorders that, in the view of the Investigator, could compromise the patient’s participation in the study; 20. not permitted to employees of the Investigator or study centre with direct involvement in the trial or in other trials under the direction of that Investigator, as well as family members of the employees or the Investigator.
    1. pazienti con tendinopatia cronica inserzionale cronica del tendine di Achille; 2. pazienti che hanno ricevuto un’iniezione locale di corticosteroidi per la tendinopatia da cui sono affetti o un’iniezione intra-articolare di corticosteroidi in un periodo &lt; 6 mesi prima dell’inclusione;3. pazienti che hanno ricevuto un trattamento fisioterapico standard (esclusa l’applicazione di impacchi freddi o caldi e/o l’uso di tutori ortopedici), una terapia elettromedicale Tecar, una terapia Laser, una terapia Iontoforetica o un Training Eccentrico per il trattamento della tendinopatia in un periodo di tempo &lt; 3 mesi prima dell’arruolamento;4, pazienti che hanno assunto antinfiammatori steroidei sistemici o che hanno ricevuto un’iniezione locale di corticosteroidi per condizioni cliniche diverse da quelle in studio in un periodo di tempo &lt; 1 mese prima dell’arruolamento; pazienti che hanno assunto FANS sistemici (quali ibuprofene, ketoprofene) in un periodo di tempo &lt;48 ore (consentito l’uso di paracetamolo), o FANS ad azione prolungata (piroxicam o naproxene), oppioidi e analgesici narcotizzanti in un periodo di tempo &lt; 7 giorni prima dell’arruolamento, o pazienti in terapia cronica con analgesici/FANS sistemici o topici; 5. segni o sintomi che possano suggerire una causa diversa del dolore che avvertono, anormalità strutturali o neurologiche congenite o acquisite nell’area interessata dell’arto, patologie articolari croniche, possibile origine traumatica o neoplastica dei sintomi, disturbi bilaterali, dolore dagli organi interni, precedente trattamento chirurgico dell’arto nell’area interessata (o trattamento chirurgico pianificato nelle 6 settimane successive l’arruolamento); 6. pazienti con fratture, dislocazioni, calcificazioni o rotture del tendine nell’area dell’arto interessato - US);7. storia di precedenti fratture o rotture del tendine nell’area dell’arto interessato, 8. patologie muscolo-scheletriche sistemiche o patologie neurologiche;9. lesioni cutanee o condizioni dermatologiche che potrebbero interferire con l’applicazione del cerotto (es. dermatiti, ulcere cutanee, scottature, infezioni cutanee, atrofie cutanee), 10. allergia nota alle sostanze attive o eccipienti contenuti nel farmaco in studio o alla terapia rescue (paracetamolo);11.patologie o trattamenti di fondo che compromettano severamente il sistema immunitario del soggetto;12,storia di reazioni anafilattiche a farmaci o reazioni allergiche in generale, che lo Sperimentatore reputi poter potenzialmente influenzare la riuscita dello studio;13.presenza di gravi disfunzioni cardiache, epatiche o renali;14.donne in gravidanza o allattamento;15.partecipazione concomitante ad altri trial clinici o alla valutazione di prodotti sperimentali nei 3 mesi precedenti o al presente studio in precedenza;16.pazienti incapaci di intendere la natura dello studio e l’obiettivo dello stesso, inclusi i possibili rischi ed effetti collaterali legati all’applicazione del prodotto in studio per motivi psicosociali o altre ragioni, e pazienti incapaci di cooperare con lo Sperimentatore e di rispettare le procedure previste dall’intero studio;17.storia di abuso di alcool o di droghe (nei 12 mesi precedenti l’arruolamento) ;18. patologie concomitanti clinicamente significative o non stabilizzate, le cui sequele o terapie impiegate potrebbero interferire con i parametri di valutazione;19. patologie metaboliche o altro come patologie maligne o disturbi psichiatrici importanti che, a giudizio dello Sperimentatore, potrebbero compromettere la partecipazione del soggetto allo studio;20.non è consentita al personale dello staff dello Sperimentatore o del centro coinvolto nello studio o in altri studi clinici sotto la responsabilità dello stesso Sperimentatore, non possono essere inclusi nello studio famigliari del personale di cui sopra o dello Sperimentatore;
    E.5 End points
    E.5.1Primary end point(s)
    Pain Reduction at Day 28 (V5) post-baseline control visit, as compared to the pre-treatment pain level at the inclusion, as scored by the patient using a 0-100 mm Visual Analogue Scale (VAS) anchored by 'no pain' (0 mm) and 'worst imaginable pain' (100 mm) while performing the standardized movement, according to their tendinopathy localisation.
    Riduzione del dolore percepito dal paziente eseguendo il movimento standardizzato identificato come più doloroso in base alla localizzazione della tendinopatia al Giorno 28 (V5) rispetto al dolore percepito prima dell’inizio del trattamento alla visita di inclusione, e indicato dal paziente con attribuzione di un punteggio in una scala analogico-visiva (VAS) da 0-100 mm, dove 0= nessun dolore e 100= peggior dolore immaginabile.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pail level perceived by the patient at Day 28, will be comparated with basal assessment.
    Il dolore percepito dal paziente al giorno 28 sarà confrontato rispetto al basale.
    E.5.2Secondary end point(s)
    • Summed Pain Intensity Difference (SPID); • Mean Daily Pain Level; • Morning Pain Level; • Evening Pain Level • Patient's self-perceived Level of Improvement • Proportion (%) of Successes at the ‘end-of-treatment’ visit (Day 28), • Functional Disability, • Overall Treatment Efficacy, judged by the Investigator at ‘end-of-treatment’ visit • Total dose (n. of tablets) of Rescue Medication (paracetamol) used • Pre-/post-treatment changes in pre-specified intra-tendineous US scan criteria reflecting tissue degeneration and inflammation The primary efficacy parameter, pre-/post-treatment pain reduction, and SPID will also be separately analysed for each of the 2 affected areas (i.e. elbow, Achilles tendon) for explorative purposes, in order to identify any possible difference in clinical effects potentially related to the plaster’s application site. • Adverse Events (AEs) and Treatment Emergent AEs (TEAEs), occurring at any time during the study. • Vital Signs (blood pressure, heart rate) • Skin irritation at the plaster application site • Presence of visible atrophic changes of the skin at the plaster application site • Overall Treatment Tolerability, independently judged by the Investigator and the patient, at the ‘end-of-treatment visit’ FOR EXPLANATION ABOUT EACH END-POINT SEE THE STUDY PROTOCOL
    • Somma della Differenza dell'Intensità del Dolore (SPID);Media del livello di dolore giornaliero;Livello di dolore al mattino;Livello di dolore alla sera; Grado di miglioramento della propria condizione tendinopatica, percepito dal paziente;Percentuale (%) di Successi alla “Visita di Fine trattamento” (Giorno 28);Disabilità funzionale valutata dal paziente;Giudizio complessivo sull’efficacia del trattamento secondo lo Sperimentatore;Dose totale (n. di compresse) di trattamento rescue (paracetamolo) assunto;Variazioni nel controllo post-trattamento rispetto al basale dei valori misurati tramite scansione US intratendinea per i seguenti criteri predefiniti che riflettono la degenerazione e infiammazione tissutale;Eventi Avversi (AE) ed Eventi Avversi emersi dopo l’inizio del trattamento in studio (TEAEs); Segni Vitali (pressione sanguigna, frequenza cardiaca) del paziente registrati alla visita di screening/arruolamento e ai successivi controlli;Irritazione della pelle nel sito di applicazione del cerotto;L’eventuale presenza di variazioni atrofiche visibili della cute nel sito di applicazione del cerotto;Giudizio complessivo sulla tollerabilità, indipendentemente espresso da Sperimentatore e paziente;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Evaluations will be done within the end of the study, 28 Days ±2, according to study protocol.
    Le valutazioni verranno eseguite entro la durata massima dello studio per paziente, 28 gg ±2 in accordo al protocollo di studio.
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stesso farmaco e placebo in tempi diversi
    Same IMP and placebo, in different times
    E.8.2.4Number of treatment arms in the trial4
    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 concerned10
    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
    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 months12
    E.8.9.1In the Member State concerned 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: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 108
    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 state108
    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 best therapy for 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 Decision2013-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-24
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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