Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-001779-29
    Sponsor's Protocol Code Number:EP-DICLO/G-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:2021-06-04
    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 number2015-001779-29
    A.3Full title of the trial
    Randomized, double-blind, parallel group, placebo-controlled, multicenter clinical trial to evaluate efficacy and safety of diclofenac 1% gel produced by Epifarma s.r.l. (Test) versus the originator Voltaren¿ Emulgel¿ 1% gel taken as Reference
    Studio clinico multicentrico, randomizzato, in doppio-cieco, a gruppi paralleli, per valutare l¿efficacia e la sicurezza di diclofenac 1% gel prodotto da Epifarma s.r.l. (Test) in confronto al riferimento Voltaren¿ Emulgel¿ 1%
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter clinical trial to evaluate efficacy and safety of diclofenac 1% gel produced by Epifarma s.r.l. compared to Voltaren¿ Emulgel¿ 1% gel
    Studio clinico multicentrico per valutare l'efficacia e la sicurezza di diclofenac 1% gel prodotto da Epifarma s.r.l. in confronto a Voltaren¿ Emulgel¿ 1% gel
    A.3.2Name or abbreviated title of the trial where available
    Multicenter clinical trial to evaluate efficacy and safety of diclofenac 1% gel produced by Epifarma
    Studio clinico multicentrico per valutare l'efficacia e la sicurezza di diclofenac 1% gel prodotto d
    A.4.1Sponsor's protocol code numberEP-DICLO/G-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 sponsorCommercial
    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 organisationLB Research S.r.l.
    B.5.2Functional name of contact pointFlavia Baruzzi
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia, 81
    B.5.3.2Town/ cityCant¿
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 031 734908
    B.5.5Fax number0039 031 7372218
    B.5.6E-mailflavia.baruzzi@lbresearch.it
    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 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 1% gel
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous 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 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) 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 Voltaren¿ Emulgel¿ 1% gel
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farma S.p.A.
    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 Gel
    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 INNDiclofenac Diethylamine
    D.3.9.2Current sponsor codeDiclofenac Diethylamine
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 placeboGel
    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
    Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments
    Pazienti con dolore e infiammazione dovuti ad un evento traumatico acuto (trauma/contusione) a livello di articolazioni, muscoli, tendini e legamenti
    E.1.1.1Medical condition in easily understood language
    Patients with injury/contusion of joints, muscles, tendons and ligaments
    Pazienti con trauma/contusione a livello di articolazioni, muscoli, tendini e legamenti
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level SOC
    E.1.2Classification code 10022117
    E.1.2Term Injury, poisoning and procedural complications
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10050584
    E.1.2Term Contusion
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    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 demonstrate that the Test diclofenac 1% gel produced by Epifarma s.r.l. is non-inferior to the comparator Voltaren¿ Emulgel¿ 1% gel, and that both Test and Reference are superior to Placebo gel, in improving pain at rest in patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments over a treatment of maximum 1 week.
    L'obiettivo primario dello studio ¿ dimostrare la non-inferiorit¿ del Test diclofenac 1% gel prodotto da Epifarma s.r.l. rispetto a Voltaren¿ Emulgel¿ 1% e la superiorit¿ di entrambi rispetto al gel Placebo nel migliorare il dolore a riposo in pazienti con dolore e infiammazione dovuti ad un evento traumatico acuto (trauma/contusione) a livello di articolazioni, muscoli, tendini e legamenti
    E.2.2Secondary objectives of the trial
    ¿ Time to resolution of pain at rest;
    ¿ VAS for pain at rest at the other time points, including the area under the curve (AUC) from baseline up to 96 ¿ 4 hours;
    ¿ Proportion of responder patients at 96 ¿ 4 hours and at the end of the study;
    ¿ VAS for pain on movement measured at any time point;
    ¿ Proportion of patients that will use rescue medication and consumption of rescue medication (paracetamol) at 96 ¿ 4 hours and at the end of the study;
    ¿ Global assessment of efficacy by investigator;
    ¿ Tolerability and safety of the IMPs, assessed through summaries of adverse events, the frequency of discontinuation of treatment due to adverse events, vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature), erythema at the IMP application site, and physical examination.
    ¿ Tempo necessario per la risoluzione del dolore;
    ¿ VAS per il dolore a riposo ai tempi previsti dal protocollo, inclusa l'area sotto la curva (AUC) dal basale fino a 96 pi¿ o meno 4 ore;
    ¿ Proporzione di pazienti responder a 96 pi¿ o meno 4 ore e alla fine dello studio;
    ¿ VAS per il dolore al movimento misurata a tutti i time point;
    ¿ Proporzione di pazienti che hanno utilizzato il farmaco di soccorso (paracetamolo) a 96 pi¿ o meno 4 ore e alla fine dello studio;
    ¿ Valutazione dell'efficacia globale da parte dello sperimentatore;
    ¿ Tollerabilit¿ e sicurezza dei farmaci in studio mediante la valutazione degli eventi avversi, della frequenza delle interruzioni anticipate del trattamento a causa di eventi avversi, dei segni vitali (frequenza cardiaca, pressione sanguigna, frequenza respiratoria, temperatura corporea), eritema al sito di applicazione ed esame obiettivo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients aged 18-65 years;
    2. Patients with acute painful and flogistic (inflammatory) disease due to acute traumatic events (injury/contusion) of joints, muscles, tendons and ligaments);
    3. Patient with pain at rest in only one body surface area affected by injury/contusion;
    4. Presence of mild to moderate pain at rest, defined as a scored VAS = 20 mm and = 60 mm, in the injured area;
    5. Female and of child-bearing potential, (i.e. not in menopausal status from at least one year or permanently sterilized) must have a negative urine pregnancy test prior the first administration;
    6. Satisfactory general health status as determined by the investigator based on medical history and physical examination;
    7. Patients must understand and provide written informed consent before they can participate in the study. He/she must understand the study procedures of the trial, and be willing to complete the required assessments.
    1. Maschi e femmine di 18-65 anni (inclusi);
    2. Pazienti con dolore e infiammazione dovuti ad un evento traumatico acuto (trauma/contusione) a livello di articolazioni, muscoli, tendini e legamenti;
    3. Pazienti con dolore a riposo in una sola area del corpo affetta dal trauma/contusione;
    4. Presenza di dolore a riposo da lieve a moderato, definito come un valore della VAS compreso tra 20 e 60 mm inclusi;
    5. Donne in età fertile (non in menopausa da almeno un anno o sterilizzatate permanentemente) devono avere un test di gravidanza negativo prima della prima applicazione;
    6. Stato di salute generale soddisfacente a giudizio dello sperimentatore, sulla base dell'anamnesi e dell'esame obiettivo;
    7. I pazienti devono comprendere tutte le procedure ed essere disposti ad adempiere a tutte le richieste dello studio e devono fornire il loro consenso informato scritto prima di poter partecipare.
    E.4Principal exclusion criteria
    1. Patient unwilling to give an informed consent approval;
    2. Patient with presence of pain at rest in more than one body surface area affected by the injury/contusion;
    3. Patient with a chronic painful or flogistic disease (from more than three months);
    4. Patient with painful or flogistic (inflammatory) disease arising from fractures or severe trauma events;
    5. Pregnancy or lactation period throughout the whole study duration;
    6. If female and of child-bearing potential, patient not using a highly effective method of birth control. Highly effective birth control methods include: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomised partner; sexual abstinence;
    7. Presence of concurrent skin disorders or open wounds in the area to be treated;
    8. History of alcohol or drug abuse;
    9. History of allergy or hypersensitivity or intolerance to diclofenac and/or to active or inactive excipients of formulation;
    10. Known hypersensitivity to non-steroid anti-inflammatory drugs, and in particular to paracetamol;
    11. 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;
    12. Any other treatment or medication for the same or other indications that, according to its pharmacological properties and in the opinion of the investigator, can alter the perception of pain (e.g. heparinoids, opioids, psychotropic agents, anti H1 agents or analgesics like glucocorticosteroids, NSAIDs, etc.) in the week before the study;
    13. Any other concomitant treatment (e.g. cosmetics, ointments at the treated area) or medication that can't be interrupted and interferes with the conduct of the trial;
    14. History of active or suspected esophageal, gastric, pyloric channel, or duodenal ulceration or bleeding within 30 days preceding screening;
    15. History of uncontrolled chronic or acute concomitant disease which, in the Investigator’s opinion, would contraindicate study participation or confound interpretation of the results;
    16. Participation in any other clinical study within 30 days prior to the screening.
    1. Paziente che non dia il consenso informato;
    2. Paziente con dolore a riposo in più di una zona del corpo interessata dalla lesione/contusione;
    3. Paziente con dolore o infiammazione cronica (da più di tre mesi);
    4. Paziente con dolore o infiammazione dovuti a fratture o traumi severi;
    5. Paziente in gravidanza o allattamento nel corso di tutto lo studio;
    6. Se donna e in età fertile, paziente che non usi un metodo contraccettivo altamente efficace. I metodi contraccettivi altamente efficaci comprendono: contraccezione ormonale combinata (contenente estrogeno e progesterone) associata all'inibizione dell'ovulazione (orale, intravaginale e transdermica); contraccezione ormonale (solo progesterone) associata all'inibizione dell'ovulazione (orale, iniettabile e impiantabile); dispositivi intrauterini; sistemi intrauterini che rilasciano ormoni; occlusione bilaterale delle tube; partner vasectomizzato; astinenza sessuale;
    7. Presenza di problemi cutanei o cicatrici aperte nell'area che deve essere trattata;
    8. Storia di abuso di alcol o droghe;
    9. Storia di allergia o ipersensibilità o intolleranza al diclofenac e/o agli eccipienti attivi o inattivi della formulazione;
    10. Ipersensibilità nota ai FANS ed in particolare al paracetamolo;
    11. Utilizzo di farmaci antinfiammatori (ad.es. acido acetilsalicilico) e analgesici (ad eccezione di paracetamolo) nella settimana precedente l'inizio dello studio. L'utilizzo cronico di piccole dosi di acido acetilsalicilico (= 162 mg/die) preso da almeno 30 giorni prima della prima applicazione per motivi diversi dall'analgesia, può essere continuato per tutta la durata dello studio;
    12. Qualsiasi altro trattamento o farmaco per la stessa o altre indicazioni che, in accordo alle sue proprietà farmacologiche e a giudizio dello sperimentatore, possa alterare la percezione del dolore (ad es. eparinoidi, oppioidi, agenti psicotropi, antistaminici o analgesici come glucocorticosteroidi, FANS, ecc.) nella settimana precedente l'inizio dello studio;
    13. Qualsiasi altro trattamento (ad es. cosmetici, unguenti sulla zona trattata) o farmaci che interferiscano con lo studio;
    14. Storia di ulcerazione attiva o sospetta dell'esofago, dello stomaco, del canale pilorico o duodenale o sanguinamento nei 30 giorni precedenti lo screening;
    15. Storia di patologie concomitanti incontrollate croniche o acute che, a giudizio dello sperimentatore, controindichino la partecipazione allo studio o confondano l'interpretazione di risultati;
    16. Partecipazione ad un altro studio clinico nei 30 giorni precedenti lo screening.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in VAS score for pain at rest 96 ± 4 hours after treatment start
    Variazioni rispetto al basale del valore della VAS per il dolore a riposo 96 ± 4 ore dopo l'inizio del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 ± 4 hours after treatment start
    96 ± 4 ore dopo l'inizio del trattamento
    E.5.2Secondary end point(s)
    Efficacy
    ¿ Time to resolution of pain at rest;
    ¿ VAS for pain at rest at the other time points, including the AUC from baseline up to 96 ¿ 4 hours;
    ¿ Proportion of responder patients at 96 ¿ 4 hours and at the end of the study. A responder patient is defined as a patient with a decrease of pain at rest = 50% vs. the baseline value;
    ¿ VAS for pain on movement measured at any time point;
    ¿ Proportion of patients that will use rescue medication and consumption of rescue medication (paracetamol) during the first 96 ¿ 4 hours and over the entire study;
    ¿ Global assessment of efficacy by investigator.
    Safety
    ¿ Summaries of adverse events (AEs) and frequency of discontinuation of treatment due to AEs;
    ¿ Vital signs (sitting heart rate, systolic/diastolic blood pressure, respiratory rate, body temperature);
    ¿ Erythema at the IMP application site;
    ¿ Physical examination
    Efficacia
    ¿ Tempo alla risoluzione del dolore a riposo;
    ¿ VAS per il dolore a riposo a tutti i tempi previsti dal protocollo, inclusa l'AUC dal basale a 96 ¿ 4 ore;
    ¿ VAS per il dolore al movimento misurata a tutti i time point;
    ¿ Proporzione di pazienti che useranno il farmaco di soccorso (paracetamolo); durante le prime 96 ¿ 4 ore e per l'intera durata dello studio;
    ¿ Valutazione dell'efficacia globale da parte dello sperimentatore.
    Sicurezza
    ¿ Eventi avversi e frequenza delle interruzioni del trattamento a causa di eventi avversi;
    ¿ Segni vitali (frequenza cardiaca, pressione sanguigna, frequenza respiratoria, temperatura corporea);
    ¿ Eritema al sito di applicazione;
    ¿ Esame obiettivo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See point E.5.2
    Vedi punto E.5.2
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned39
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    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
    This trial is considered closed when all e-CRFs are satisfactorily completed and the database is finally locked.
    Lo studio viene considerato terminato quando tutte le e-CRFs sono state completate e il database ¿ stato chiuso
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 49
    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 state359
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 749
    F.4.2.2In the whole clinical trial 749
    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)
    None
    Nessuno
    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 Decision2017-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-04-04
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 03 15:56:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA