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    Summary
    EudraCT Number:2018-004886-15
    Sponsor's Protocol Code Number:MTA:CT4-09-18--Sponsor:18I-Fsg08
    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:2021-01-22
    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 number2018-004886-15
    A.3Full title of the trial
    Evaluation of Treatment Satisfaction, Effectiveness and Tolerability in Subjects treated with Low-dose Diclofenac Epolamine Soft Capsules for Acute, Mild or Moderate Musculoskeletal Pain
    Valutazione della soddisfazione, dell'efficacia e della tollerabilità del trattamento in soggetti trattati con capsule molli di diclofenac epolamina a basso dosaggio per dolore muscoloscheletrico acuto, lieve o moderato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Treatment Satisfaction, Effectiveness and Tolerability in Subjects treated with Low-dose Diclofenac Epolamine Soft Capsules for Acute, Mild or Moderate Musculoskeletal Pain
    Valutazione della soddisfazione, dell'efficacia e della tollerabilità del trattamento in soggetti trattati con capsule molli di diclofenac epolamina a basso dosaggio per dolore muscoloscheletrico acuto, lieve o moderato
    A.3.2Name or abbreviated title of the trial where available
    DHEP soft capsules in musculoskeletal pain
    DHEP Capsule molli per il dolore muscolo-scheletrico
    A.4.1Sponsor's protocol code numberMTA:CT4-09-18--Sponsor:18I-Fsg08
    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 Institute 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 Scientific Affairs IBSA
    B.5.3 Address:
    B.5.3.1Street AddressVia del Piano
    B.5.3.2Town/ cityPambio-Noranco
    B.5.3.3Post code6915
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041583601000
    B.5.5Fax number0041583601655
    B.5.6E-mailsd@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 FLECTORGO 12,5 mg capsule molli
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA Farmaceutici Italia S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 epolamine 12,5 mg soft capsules
    D.3.2Product code [Diclofenac epolamine 12, 5 mg soft capsules]
    D.3.4Pharmaceutical form Capsule, soft
    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 INNDICLOFENAC EPOLAMINA
    D.3.9.1CAS number 119623-66-4
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameFLECTORGO
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 with acute, mild or moderate musculoskeletal pain
    Pazienti con dolore muscoloscheletrico acuto, lieve o moderato
    E.1.1.1Medical condition in easily understood language
    Patients with acute, mild or moderate musculoskeletal pain
    Pazienti con dolore muscoloscheletrico acuto, lieve o moderato
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028391
    E.1.2Term Musculoskeletal pain
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue 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 assess the overall subject’s satisfaction with 12.5 mg diclofenac soft capsules (FLECTORGO 12.5 mg) when used as needed according to the approved dose regimen and administration conditions, in patients with acute, mild or moderate musculoskeletal pain
    Valutare la soddisfazione generale in seguito alla somministrazione del farmaco diclofenac 12,5 mg –capsule molli (FLECTORGO 12.5 mg) usato secondo le necessità, secondo il regime posologico approvato e le condizioni di somministrazione, in pazienti che soffrono di dolore muscoloscheletrico acuto, lieve o moderato
    E.2.2Secondary objectives of the trial
    To evaluate the analgesic effect after the first diclofenac soft capsule administration (over 0-3 hours), over 0-24 hours, 0-48 hours and 0-72 hours and the time to onset of the analgesic effect; to assess the subject’s satisfaction with efficacy in terms of time to pain relief, amount of pain relief, and duration of pain relief; to evaluate safety and tolerability of the product.
    Valutare l'effetto analgesico dopo la prima somministrazione di diclofenac (tra le 0-3 ore), tra le 0-24 ore, le 0-48 ore e le 0-72 ore e il tempo di comparsa dell'effetto analgesico; valutare la soddisfazione del paziente rispetto all'efficacia in termini di tempo per alleviare il dolore, in termini quantità e durata di sollievo dal dolore; infine valutare la sicurezza e la tollerabilità del prodotto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient is = or >18 years-old;
    2. Acute mild or moderate musculoskeletal pain such as back pain, neck pain, shoulder pain, tendon or ligament pain, myalgia) started = 72 hours prior to inclusion in the trial. Pain can be either traumatic (e.g. due to an injury) or, postural/mechanical pain (e.g. due to postural strain, changes in posture or poor body mechanics, repetitive movements, prolonged immobilization);
    3. Mild or moderate acute musculoskeletal pain to be defined at baseline as greater or equal to 20 mm and greater or equal to 60 mm on a 0-100 mm on a Visual Analogue Scale. The VAS-pain baseline assessment should be taken ensuring that no prior forbidden treatments are taken;
    4. Informed consent obtained;
    5. Female of childbearing potential (i.e., not permanently sterilised - post hysterectomy or tubal ligation status – or not postmenopausal) must be using an appropriate method of contraception according to the definition of Note 3 of ICH M3 Guideline during >= 30 days before inclusion and for the whole duration of the study and they must have a negative pregnancy test at Visit 1.
    1. Soggetti di età maggiore o uguale a 18 anni;
    2. Dolore muscoloscheletrico da lieve a moderato acuto (come dolore alla schiena, dolore al collo, dolore alla spalla, dolore ai tendini o ai legamenti, mialgia) iniziato 72 ore prima dell'inclusione nello studio. Il dolore può essere sia traumatico (ad esempio a causa di un infortunio) o dolore posturale/meccanico (ad esempio a causa di deformazioni posturali, cambiamenti nella postura o scarsa meccanica del corpo, movimenti ripetitivi, immobilizzazione prolungata);
    3. Dolore muscoloscheletrico lieve o moderato acuto definito al basale come uguale o maggiore a 20 mm e uguale o minore a 60 mm su 0-100 mm della scala analogica visiva. La valutazione al basale del dolore tramite la scala VAS dovrebbe essere fatta assicurandosi che non vengano presi preventivamente dei trattamenti;
    4. Consenso informato ottenuto;
    5. Le donne in età fertile (cioè non sterilizzate in modo permanente - post isterectomia o stato di legatura delle tube - o non in postmenopausa) devono utilizzare un metodo contraccettivo appropriato secondo la definizione della nota 3 della linea guida ICH M3 durante i >=30 giorni prima dell'inclusione e per tutta la durata dello studio e devono avere un test di gravidanza negativo alla Visita 1.
    E.4Principal exclusion criteria
    1. Musculoskeletal pain of neuropathic or post-surgical origin;
    2. Musculoskeletal pain due to a chronic disease requiring treatment with NSAIDS for more than 3 days, according to the Investigator’s judgment;
    3. Pain associated with chills or fever, or dysmenorrhea or endometriosis;
    4. Current treatment with any muscle relaxant or any drugs having muscle relaxant properties either systemic or topical;
    5. Known or suspected hypersensitivity, or intolerance to diclofenac and/or any other ingredient in the tested formulation;
    6. Prior use of OTC or prescription NSAIDs within 36 hours of VAS-pain baseline assessment with the following exceptions:
    - subjects with prior use of long-acting NSAIDs such as piroxicam within 72 hours before study entry or prior use of narcotic analgesics within 7 days of study entry or prior use of systemic anti-inflammatory steroidal drugs within 30 days of study entry are excluded;
    - subjects with prior use of paracetamol < or = 1000 mg, ibuprofen < or = 400 mg, aspirin < or = 600 mg are not excluded if last dose is taken > 6 hours before the VAS assessment;
    7. Active or suspected gastric or intestinal ulcer, bleeding or perforation and/or history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
    8. History of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
    9. Unexplained blood-forming disorders;
    10. Established congestive heart failure (NYHA class II-IV), ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease;
    11. Severe hepatic, renal or cardiac failure;
    12. Bronchospasm, asthma, urticaria, or acute rhinitis following prior aspirin or NSAIDs intake;
    13. Any clinical condition that, in the opinion of the Investigator, may interfere with the study drug;
    14. Subjects participated in any other protocol involving administration of an investigational agent within 3 months before Visit 1;
    15. Subjects pregnant or breast feeding;
    16. Unable, in the opinion of the Investigator, to comply with the study procedures.
    1. Dolore muscoloscheletrico di origine neuropatica o post-chirurgica ;
    2. Dolore muscoloscheletrico dovuto a una malattia cronica che richiede un trattamento con FANS per più di 3 giorni, secondo il parere dello sperimentatore;
    3. Dolore associato a brividi o febbre, o dismenorrea o endometriosi;
    4. Trattamento attuale con qualsiasi rilassante muscolare o qualsiasi altro farmaco con proprietà rilassanti muscolari sia sistemico che locale;
    5. Ipersensibilità nota o sospetta o intolleranza al diclofenac e/o qualsiasi altro ingrediente nella formulazione testata;
    6. Uso precedente di un OTC o di FANS prescritti entro 36 ore dalla valutazione basale del dolore VAS con le seguenti eccezioni:
    - pazienti con uso precedente di FANS a lunga durata d'azione come piroxicam entro 72 ore prima dell'inizio dello studio o uso precedente di analgesici narcotici entro 7 giorni dall'entrata nello studio o uso precedente di farmaci steroidei antinfiammatori sistemici, entro 30 giorni dall'entrata nello studio sono esclusi;
    - soggetti con uso precedente di paracetamolo < o = 1000 mg, ibuprofene < o = 400 mg, aspirina < o = 600 mg non sono esclusi se l'ultima dose è stata assunta più di 6 ore prima della valutazione VAS;
    7. Ulcera gastrica o intestinale attiva o sospetta, sanguinamento o perforazione e/o anamnesi di sanguinamento o perforazione gastrointestinale, correlata alla precedente terapia con FANS;
    8. Storia di ulcera peptica ricorrente/emorragia (due o più episodi distinti di ulcerazione o emorragia dimostrata);
    9. Disturbi del sangue inspiegabili;
    10. Insufficienza cardiaca congestizia accertata (classe II-IV NYHA), cardiopatia ischemica, malattia arteriosa periferica e/o malattia cerebrovascolare;
    11. Insufficienza epatica, renale o cardiaca grave;
    12. Broncospasmo, asma, orticaria o rinite acuta in seguito all'assunzione di aspirina o FANS;
    13. Qualsiasi condizione clinica che, secondo il parere dello sperimentatore, possa interferire con il farmaco in studio;
    14. Soggetti che hanno partecipato a qualsiasi altro protocollo riguardante la somministrazione di un agente investigativo entro 3 mesi prima della Visita 1
    15. Soggetti in gravidanza o che allattano;
    16. Soggetti incapaci, secondo il parere dello sperimentatore, di osservare le procedure di studio.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion (%) of participants overall satisfied (very satisfied or satisfied) with FLECTORGO 12.5 mg 72 ± 7 hours after initiation of treatment as assessed using the Overall Satisfaction Question of the Pain Treatment Satisfaction Scale (PTSS). Responses will be rated from very satisfied (1) to very dissatisfied (5).
    Proporzione (%) dei partecipanti complessivamente soddisfatti (molto soddisfatti o soddisfatti) con FLECTORGO 12,5 mg a 72 ± 7 ore dopo l'inizio del trattamento, valutato utilizzando la scala di valutazione “Scala di soddisfazione” del trattamento del dolore (PTSS). Le risposte saranno valutate da molto soddisfatto (1) a molto insoddisfatto (5).
    E.5.1.1Timepoint(s) of evaluation of this end point
    For all the study period
    Per tutta la durata dello studio
    E.5.2Secondary end point(s)
    • Sum of pain intensity difference (VAS SPID) (calculated as AUC) over 0-3 hours (SPID-3), over 0-24 hours (SPID-24) after time 0, over 0-48 hours (SPID-48), and over 0-72 hours (SPID-72) after time 0 or until the last VAS time point after the last intake if treatment is not taken over three days;
    • VAS Pain intensity difference (PID) based on subject’s self-assessment of pain intensity by means of VAS at each scheduled assessment time point after the first dose;
    • Time to onset of the analgesic effect as expressed by asking the subject 1 hour after each diclofenac intake the time (in minutes) he/she experienced:
    - a slight pain relief;
    - a significant pain relief;
    - a complete pain relief;
    • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy - Time to Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy - Time to Pain Relief Satisfaction Question (=time it took medication to work) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5);
    • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy – Amount of Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy – Amount of Pain Relief Satisfaction Question (=the amount of pain relief provided by the medication) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5);
    • Proportion (%) of participants satisfied (very satisfied or satisfied) with the Efficacy – Duration of Pain Relief 72 ± 7 hours after initiation of treatment with FLECTORGO as assessed using the Efficacy – Duration of Pain Relief Satisfaction Question (=the duration of pain relief provided by the medication) of the PTSS. Responses will be rated from very satisfied (1) to very dissatisfied (5).
    • Somma della differenza di intensità del dolore (VAS SPID) (calcolata come AUC) tra 0-3 ore (SPID-3), tra 0-24 ore (SPID-24) dopo il tempo 0, tra 0-48 ore (SPID-48) e tra 0-72 ore (SPID-72) dopo il tempo 0 o fino all'ultimo punto temporale VAS dopo l'ultima assunzione se il trattamento non viene eseguito nell'arco di tre giorni;.
    • Differenza di intensità del dolore VAS (PID) basato sull'auto-valutazione del soggetto sull'intensità del dolore mediante VAS ad ogni momento della valutazione programmato dopo la prima dose.
    • Tempo di comparsa dell'effetto analgesico espresso chiedendo al soggetto 1 ora dopo ogni assunzione di diclofenac il tempo (minuti) in cui avrà cominciato a sentire:
    - un leggero sollievo rispetto al dolore iniziale;
    - un significativo sollievo dal dolore iniziale;
    - un completo sollievo dal dolore iniziale.
    • Proporzione (%) dei partecipanti soddisfatti (molto soddisfatti o soddisfatti) con Efficacia - Tempo per alleviare il dolore 72 ± 7 ore dopo l'inizio del trattamento con FLECTORGO valutato tramite la domanda sulla soddisfazione del PTSS relativa a l’Efficacia - Tempo per alleviare il dolore (= tempo che prende il farmaco per agire) del PTSS. Le risposte saranno valutate da molto soddisfatto (1) a molto insoddisfatto (5);
    • Proporzione (%) dei partecipanti soddisfatti (molto soddisfatti o soddisfatti) con Efficacia - Quantità di sollievo dal dolore 72 ± 7 ore dopo l'inizio del trattamento con FLECTORGO valutato tramite la domanda sulla soddisfazione del PTSS relativa a l’Efficacia – Quantità di sollievo del dolore (= la quantità del sollievo dal dolore grazie al farmaco). Le risposte saranno valutate da molto soddisfatto (1) a molto insoddisfatto (5);

    • Proporzione (%) dei partecipanti soddisfatti (molto soddisfatti o soddisfatti) con Efficacia - Durata del sollievo dal dolore 72 ± 7 ore dopo l'inizio del trattamento con FLECTORGO valutato tramite la domanda sulla soddisfazione del PTSS relativa a l’Efficacia – Durata del sollievo dal dolore (= la durata del sollievo dal dolore grazie al farmaco). Le risposte saranno valutate da molto soddisfatto (1) a molto insoddisfatto (5).
    E.5.2.1Timepoint(s) of evaluation of this end point
    For all the study period
    Per tutta la durata dello 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Overall patient satisfaction after administration of FLECTORGO 12.5 mg
    Soddisfazione generale del paziente in seguito alla somministrazione di FLECTORGO 12,5 mg
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned4
    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 Information not present in EudraCT
    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 months2
    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 months2
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    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)
    At the end of the study, patients will be treated as normal clinical practice
    Alla fine dello studio i pazienti verranno trattati come da normale pratica clinica
    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 Decision2019-05-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-14
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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