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    Summary
    EudraCT Number:2019-001660-30
    Sponsor's Protocol Code Number:CHL.3/01-2019/M
    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:2020-07-30
    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 number2019-001660-30
    A.3Full title of the trial
    A prospective, observer-masked, randomized clinical trial to investigate and compare the clinical efficacy of chloroprocaine 3% gel and tetracaine 0.5% eye drop as topical anesthetics in phacoemulsification.
    Studio clinico prospettico, randomizzato con valutatore in cieco volto a determinare e confrontare l’efficacia clinica della Cloroprocaina 3% gel e della Tetracaina 0.5% gocce oculari come anestetico topico nell’intervento chirurgico di facoemulsificazione.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate and compare the efficacy of local anesthetics Chloroprocaine 3% gel and Tetracaine 0.5% eye drops in cataract surgery.
    Studio per valutare e confrontare l'efficacia degli anestetici locali Cloroprocaina 3% in gel e Tetracaina 0.5% collirio nell'intervento di cataratta.
    A.3.2Name or abbreviated title of the trial where available
    CHL.3/01-2019/M
    CHL.3/01-2019/M
    A.4.1Sponsor's protocol code numberCHL.3/01-2019/M
    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 SponsorSINTETICA S.A.
    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 supportSintetica SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLink Neuroscience and Health Care srl - L.N.Age srl
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia Luigi Rizzo 62
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00136
    B.5.3.4CountryItaly
    B.5.4Telephone number0639746749
    B.5.5Fax number0631077733
    B.5.6E-mailinfo@lnage.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 Minims Tetracaine Hydrochloride 0.5% w/v Eye Drops, Solution
    D.2.1.1.2Name of the Marketing Authorisation holderBausch & Lomb UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTetracaina Cloridrato 0.5%
    D.3.2Product code [PL 03468/0082 (AIC UK)]
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTetracaina 0.5%
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name Ampres
    D.2.1.1.2Name of the Marketing Authorisation holderSintetica SA
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 nameCloroprocaina Cloridrato 3%
    D.3.2Product code [65563 (AIC Svizzera)]
    D.3.4Pharmaceutical form Eye gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeCloroprocaina 3%
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    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 undergoing unilateral phacoemulsification
    Pazienti sottoposti ad intervento di facoemulsificazione monolaterale
    E.1.1.1Medical condition in easily understood language
    Patients undergoing unilateral cataract surgery
    Pazienti sottoposti ad intervento di cataratta monolaterale
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10059285
    E.1.2Term Phacoemulsification
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Equivalence evaluation of Test versus Reference products in terms of proportion of subjects with a successful surface anesthesia for cataract surgery, without any supplementation (see definitions below) at T4 (just before Intra Ocular Lens implantation)
    Successful surface anesthesia: The patient assessment of ocular discomfort during surgery must be 0 (=No pain or discomfort) or 1 (=Occasional pressure sensation, less than 5 separated times during procedure) without any supplementation at T4.
    Supplementation: Intra-operative analgesia, including additional LA drops administration, after the beginning of the surgery.
    Valutazione dell’equivalenza tra il medicinale oggetto di Studio e il prodotto di riferimento in termini di proporzione dei soggetti con un’anestesia superficiale riuscita per l’intervento chirurgico della cataratta senza alcuna integrazione (v. definizioni che seguono) nel momento T4 (immediatamente prima dell’impianto della lente intraoculare)
    Anestesia superficiale riuscita: La valutazione che il paziente dà dei fastidi oculari durante l’intervento deve essere pari a 0 (=Nessun dolore o fastidio) o pari a 1 (= Sensazione occasionale di pressione, meno di 5 volte distinte durante la procedura) senza alcun integrazione nel momento T4.
    Integrazione: analgesia intraoperatoria, inclusa somministrazione di ulteriori gocce di analgesico topico, dopo l’inizio dell’intervento chirurgico.
    E.2.2Secondary objectives of the trial
    Assess the clinical efficacy and safety of 3% chloroprocaine gel compared to those of tetracaine 0.5% eye drop.
    Valutare efficacia clinica e sicurezza di cloroprocaina 3% gel rispetto a quelle di tetracaina 0.5% collirio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated informed consent
    2. Male or female aged > = 18 years
    3. Senile or pre-senile cataract
    4. Scheduled to undergo cataract surgery in a single eye at a time (clear corneal self-sealing incisions - phacoemulsification – foldable intra-ocular lens surgery with injector)
    1. Consenso informato firmato e datato;
    2. Maschio o femmina di età > = 18
    3. Cataratta senile o presenile;
    4. Paziente per cui è previsto un intervento alla cataratta, un solo occhio alla volta (incisioni corneali autochiudenti nette o trasparenti - facoemulsificazione – intervento chirurgico con lenti intraoculari pieghevoli con iniettore)
    E.4Principal exclusion criteria
    Ophthalmic exclusion criteria
    - Surgical conditions in the eye to be operated:
    1. Combined surgery
    2. Previous intraocular surgery
    3. Previous corneal refractive surgeries less than 6 months before screening
    - Non-surgical conditions in the eye to be operated:
    4. Non Senile or non pre-senile cataract (e.g.: traumatic, pathological or congenital cataract)
    5. Pupillary abnormalities (irregular, etc.)
    6. Iris synechiae
    7. Eye movement disorder (nystagmus, etc.)
    8. Dacryocystitis and all other pathologies of tears drainage system
    9. History of Inflammatory ocular disease (Iritis, uveitis, herpetic keratitis)
    10. Corneal, epithelial, stromal or endothelial, residual or evolutionary disease (including corneal ulceration and superficial punctuate keratitis)
    11. History of ocular traumatism, infection or inflammation within the last 3 months
    12. Pseudo-exfoliation, exfoliative syndrome
    13. Prior intravitreal injections within 7 days of the surgery
    14. IOP over 25mmHg under treatment
    - Ophthalmic conditions in the contra-lateral eye:
    15. Best corrected visual acuity < 1/10
    16. Patient already included in the study for phakoexeresis
    17. History of ophthalmic surgical complication (cystoid macular oedema, etc.)
    - Systemic/non ophthalmicexclusioncriteria
    --General history:
    18. Diabetesmellitus
    19. Surdity
    20. Pakinsondisease
    21. Excessive anxiety
    22. Any other medical or surgical history, disorder or disease such as acute or chronic severe organic disease: hepatic, endocrine neoplasic, hematological diseases, severe psychiatric illness, relevant cardiovascular abnormalities (such as unstable angina, bradycardia, atrial fibrillation,uncontrolled hypertension: systolic blood pressure over 140 mm Hg, diastolic blood pressure over 90 mmHg) and/or any complicating factor or structural abnormality judged by the investigator to be incompatible with the study.
    --Allergic history:
    23. Known hypersensitivity to sulfonamides products or any of the components of the study medications or to test products Specific exclusion criteria for women
    24. Pregnancy (positive pregnancy test), lactation
    25. Women of childbearing potential without an acceptable effective method of contraception (oral contraceptive, intra-uterine device, subcutaneous contraceptive implant) until end of the study participation
    OR
    26. Women not hysterectomized, not menopaused nor surgically sterilized.
    - Exclusion criteria related to general conditions
    27. Inability of patient and/or relatives to understand the study procedures and thus inability to give informed consent
    28. Non-compliant patient and/or relatives (e.g. not willing to attend the follow-up visits, way of life interfering with compliance)
    29. Participation in anotherclinicalstudy
    30. Already included once in this study
    31. Ward of court
    32. Patient not covered by the Social Security
    Criteri di esclusione oftalmici
    - Condizioni chirurgiche dell’occhio da operare:
    1. Intervento chirurgico combinato
    2. Intervento intraoculare precedente
    3. Precedenti interventi di chirurgia refrattiva corneale a meno di 6 mesi dallo screening
    - Condizioni non chirurgiche dell’occhio da operare:
    4. Cataratta non senile o presenile (es.: cataratta di origine traumatica, patologica o congenita)
    5. Anomalie della pupilla (irregolare, ecc.)
    6. Sinechie a carico dell’iride
    7. Disturbo dei movimenti oculari (nistagmo, ecc.)
    8. Dacriocistite e tutte le altre patologie dell’apparato lacrimale
    9. Storia pregressa di patologia oculare infiammatoria (irite, uveite, cheratite erpetica)
    10. Patologia corneale, epiteliale, stromale o endoteliale, residua o evolutiva (incluse ulcerazione corneale e cheratite puntata superficiale)
    11. Storia pregressa di traumi, infezioni o infiammazioni oculari entro i 3 mesi antecedenti
    12. Pseudoesfoliazione, sindrome esfoliativa
    13. Precedenti iniezioni intravitreali entro 7 giorni dall’intervento chirurgico
    14. IOP superiore a 25mmHg in trattamento
    - Condizioni oftalmiche dell’occhio controlaterale:
    15. Massima acuità visiva corretta< 1/10
    16. Paziente già incluso nello studio per facoexeresi
    17. Storia pregressa di complicanze chirurgiche oftalmiche (edema maculare cistoide,
    ecc.)
    - Criteri di esclusione sistemici/non oftalmici
    --Anamnesi medica generale:
    18. Diabete mellito
    19. Sordità
    20. Morbo di Parkinson
    21. Ansia eccessiva
    22. Qualsiasi altra anamnesi medica o chirurgica, disturbo o malattia come una patologia organica grave o acuta: epatica, neoplasia endocrina, patologie ematiche, malattie psichiatriche gravi, anomalie cardiovascolari di rilievo (quali angina instabile, bradicardia, fibrillazione atriale, ipertensione non controllata: pressione sanguigna sistolica superiore a 140 mm Hg, pressione sanguigna diastolica superiore a 90 mmHg) e/o qualsiasi altro fattore di complicazione o anomalia strutturale che lo Sperimentatore ritenga incompatibile con lo Studio.
    --Storia pregressa di allergie:
    23. Ipersensibilità nota ad uno dei componenti dei farmaci sulfonamidici o qualsiasi componente dei farmaci in studio o ai prodotti oggetto di studio
    - Criteri di esclusioni specifici per donne
    24. Gravidanza (test di gravidanza positivo), allattamento
    25. Donne in età fertile che non adottano accettabili metodi contraccettivi efficaci (contraccettivo orale, dispositivo contraccettivo intrauterino, impianto contraccettivo sottocutaneo) fino alla fine della partecipazione allo studio
    O
    26. Donne non isterectomizzate, non in menopausa o non sterilizzate chirurgicamente.
    - Criteri di esclusione relative a condizioni generali
    27. Incapacità del paziente e/o dei suoi familiari a comprendere le procedure previste dallo Studio e, quindi, non in grado di dare il proprio consenso informato
    28. Paziente e/o familiari non collaborativi (ad es. non intenzionati a effettuare le visite di follow-up, stile di vita che interferisce con il rispetto di quanto previsto dallo studio)
    29. Partecipazione ad altro studio clinico
    30. Essere stato già incluso una volta in questo studio
    31. Soggetti posti sotto tutela giudiziale
    32. Paziente non coperto da Previdenza Sociale
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in each treatment group with a successful surface anesthesia, without any supplementation at the time point T4.
    A successful surface anesthesia is equal to 1 and is defined as ocular discomfort equal to 0 (=no pain or pressure) or 1 (=occasional pressure sensation, less than 5 separated times during procedure). It is equal to 0 otherwise (e.g. ocular discomfort > 1).
    La proporzione di soggetti in ciascun gruppo di trattamento con un’anestesia superficiale riuscita, senza alcuna integrazione nel momento T4.
    Un’anestesia superficiale riuscita è pari a 1 e si definisce come fastidio oculare pari a 0 (=nessun dolore o pressione) o pari a 1 (=sensazione occasionale di pressione, meno di 5 volte distinte durante la procedura). É pari a 0 per il resto (es. fastidio oculare > 1).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Just before intra ocular lens implantation (V2)
    Poco prima dell'impianto della lente intraoculare (V2)
    E.5.2Secondary end point(s)
    Efficacy end-points during surgery:
    - Successful surface anesthesia at T1, T2 and T3 based on patient questioning: Patient’s operated eye discomfort.
    - Time to obtain sufficient anesthesia (use of forceps).
    - Total time of anesthesia
    - Blinking reflex dropping a water drop at the end of the surgery
    - Number of supplemental drops necessary for obtaining and/or maintaining anesthesia
    - Supplementary treatments (general anesthesia or intra-operative systemic analgesia) necessary for obtaining and/or maintaining anesthesia
    - Total surgical time
    - Assessment of surgical comfort by the surgeon of each stage of the surgical procedure.
    - Assessment of the global efficacy by the surgeon for anesthesia.
    Safety end-points:
    - Ocular symptoms (pain, irritation/burning/stinging, photophobia, foreign body sensation) will be graded by the patients according to the following scale: 0 = absent, 1 = mild, 2 = moderate, 3 = severe.
    - Objective ocular signs (palpebral edema, chemosis, conjunctival hyperemia, conjunctival discharge, follico-papillary conjunctivitis, corneal staining punctuations, anterior chamber cells) assessed by slit lamp examination, flare, and other objective ocular signs will be graded according to the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe.
    Modification of the basal status of the following assessments:
    - Slit lamp examination and fluorescein test
    - Endothelial cell counts (specular microscopy)
    - Corneal thickness (pachymetry)
    - Best far corrected visual acuity
    - Fundoscopy
    - Intra-ocular pressure
    - Vital signs (blood pressure and heart rate)
    - AEs occurrence
    - Surgeon satisfaction: “How do you consider the study product global tolerance” will be graded according to the following scale: 0 = very satisfactory, 1 = satisfactory, 2 = not very satisfactory, 3 = unsatisfactory.
    - Patient global satisfaction at Visit 3/D2 (5-scale points questionaire read by a masked observer).
    Endpoint di efficacia durante l’intervento chirurgico:
    - Anestesia superficiale riuscita nei momenti T1, T2 e T3 basata su domande al paziente: fastidio all’occhio operato del paziente.
    - Tempi per ottenere anestesia sufficiente (uso delle pinze).
    - Durata totale dell’anestesia
    - Riflesso del battito di palpebra facendo cadere una goccia d’acqua al termine dell’intervento chirurgico
    - Numero di ulteriori gocce necessarie per ottenere e/o prolungare l’anestesia/mantenimento dello stato di anestesia
    - Trattamenti supplementari (anestesia generale o analgesia sistemica intraoperatoria) necessaria per ottenere e/o mantenere lo stato di anestesia
    - Durata totale dell’intervento chirurgico
    - Valutazione del comfort chirurgico da parte del chirurgo in ogni fase della procedura chirurgica.
    - Valutazione da parte del chirurgo sull’efficacia complessiva dell’anestesia.
    Endopoint di sicurezza:
    - Sintomi oculari (dolore, irritazione/bruciore/fitte, fotofobia, sensazione di corpo estraneo) saranno classificati dai pazienti secondo la scala indicata di seguito: 0 = assente, 1 = lieve, 2 = moderato, 3 = grave.
    - Segni oculari obiettivi (edema palpebrale, chemosi, iperemia congiuntivale, scolo congiuntivale, congiuntivite follicolare papillare, staining corneale, cellule nel segmento anteriore dell’occhio) valutati eseguendo un esame con lampada a fessura, arrossamento e altri segni clinici oculari che saranno classificati in base alla scala indicata di seguito: 0 = assente, 1 = lieve, 2 = moderato, 3 = grave.
    Modifiche dello stato basale tramite gli esami indicati di seguito:
    - esame con lampada a fessura e test con fluoresceina
    - conta delle cellule endoteliali (microscopia speculare)
    - spessore corneale (pachimetria)
    - massima acuità visiva a distanza corretta
    - fondoscopia
    - pressione intraoculare
    - Parametri vitali (pressione sanguigna e battito cardiaco)
    - verificarsi di eventi avversi
    - Soddisfazione del chirurgo: “Come valuta la tolleranza complessiva del prodotto oggetto di studio” sarà valutata in base alla scala indicate di seguito: 0 = molto soddisfacente, 1 = soddisfacente, 2 = non molto soddisfacente, 3 = insoddisfacente.
    - Soddisfazione complessiva del paziente alla Visita 3/G 2 (questionario a 5 punti letto dall’osservatore in cieco).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The efficacy end-points will be evaluated during surgery.
    The safety end-points will be avaluated:
    - Ocular symptoms and signs: V1, V4
    - Slit lamp examination and fluorescein test: V1, V4
    - Endothelial cell counts (specular microscopy): V1, V4
    - Corneal thickness (pachymetry): V1, V4
    - Best far corrected visual acuity: V1, V4
    - Fundoscopy: V1, V4
    - Intra-ocular pressure: V1, V4
    - Vital signs (blood pressure and heart rate): V1, V2, V4
    - AE: V2, V3, V4, V5
    - Patient global satisfaction: V3
    - Surgeon satisfaction: V2
    Gli end-point di efficacia saranno misurati durante l'intervento chirurgico.
    gli end-point di sicurezza saranno misurati:
    - Sintomi e segni oculari: V1, V4
    - Esame con lampada a fessura e test con fluoresceina: V1, V4
    - Conta delle cellule endoteliali (microscopia speculare): V1, V4
    - Spessore corneale: pachimetria: V1, V4
    - Massima acuità visiva a distanza corretta: V1, V4
    - Fondoscopia: V1, V4
    - Pressione intraoculare: V1, V4
    - Parametri vitali (pressione sanguigna e battito cardiaco): V1, V2, V4
    - AE: V2, V3, V4, V5
    - Soddisfazione complessiva del paziente: V3
    - Soddisfazione del chirurgo: V2
    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 No
    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 concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    The end of the trial is defined as the Last Visit of the Last Patient.
    The study will be considered terminated at the date of the last visit of the last subject, upon completion of any follow-up procedure described in protocol.
    La fine dello studio è definita come l'Ultima Visita dell'Ultimo Paziente.
    Lo studio sarà considerato terminato alla data dell'ultima visita dell'ultimo paziente, al completamento di ogni procedura di follow-up prevista dal protocollo.
    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 months7
    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 months7
    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: 228
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 114
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 342
    F.4.2.2In the whole clinical trial 342
    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 discretion of the Investigator who follows the patient.
    A discrezione dello Sperimentatore che segue il 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 Decision2020-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-30
    P. End of Trial
    P.End of Trial StatusCompleted
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