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    Summary
    EudraCT Number:2018-002380-26
    Sponsor's Protocol Code Number:Somagel
    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:2020-11-04
    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 number2018-002380-26
    A.3Full title of the trial
    Single-group, open study on the systemic bioavailability, safety and local tolerability of a new gel formulation of Somatoline¿ in 30 healthy women.
    Single-group, open study on the systemic bioavailability, safety and local tolerability of a new gel formulation of Somatoline¿ in 30 healthy women.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-group, open study on the systemic bioavailability, safety and local tolerability of a new gel formulation of Somatoline¿ in 30 healthy women.
    Studio a braccio singolo, in aperto, su un gruppo di 30 donne sane per valutare la biodisponibilit¿, la sicurezza e la tollerabilit¿ locale della nuova formulazione in gel di Somatoline¿.
    A.3.2Name or abbreviated title of the trial where available
    Somagel
    Somagel
    A.4.1Sponsor's protocol code numberSomagel
    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 SponsorSOCIETÀ ITALO BRITANNICA L. MANETTI - H. ROBERTS & C. PER AZIONI
    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 supportSociet¿ Italo Britannica L. Manetti - H. Robert
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCronos Ricerche Cliniche Srl
    B.5.2Functional name of contact pointServizio Informazione sulla Sperime
    B.5.3 Address:
    B.5.3.1Street AddressVia dei Pratoni, 16
    B.5.3.2Town/ cityScandicci (FI)
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.4Telephone number3459966300
    B.5.5Fax number0267382868
    B.5.6E-mailedimartino@cronos.srl
    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 SOMATOLINE - 0.1% + 0.3% EMULSIONE CUTANEA 10 BUSTINE
    D.2.1.1.2Name of the Marketing Authorisation holderSOCIETA' ITALO BRITANNICA L. MANETTI - H. ROBERTS e C. PER AZIONI
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSomatoline¿ gel
    D.3.2Product code Somatoline¿ gel
    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 INN00179300
    D.3.9.1CAS number 51-48-9
    D.3.9.2Current sponsor codeL-TIROXINA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNESCINA
    D.3.9.1CAS number 6805-41-0
    D.3.9.2Current sponsor codeESCINA
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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
    Edematous fibrosclerotic panniculopathy
    Panniculopatia Edemato Fibro Sclerotica
    E.1.1.1Medical condition in easily understood language
    Cellulite
    Cellulite
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10040785
    E.1.2Term Skin and subcutaneous tissue disorders
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The primary objective of the study is to assess the systemic bioavailability of l-T4 in female subjects with after repeated cutaneous of a gel formulation of Somatoline¿ for 28 days.
    L'obiettivo principale dello studio ¿ valutare la biodisponibilit¿ sistemica di l-T4 in soggetti femminili dopo applicazione cutanea della nuova formulazione in gel di Somatoline¿ per 28 giorni.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:
    - to assess the systemic bioavailability of rT3, T3 and TSH, after repeated cutaneous application of a gel formulation of Somatoline¿ in female subjects
    - to assess the local and systemic tolerability after repeated cutaneous application of a gel formulation of Somatoline¿ in female subjects
    Gli obiettivi secondari dello studio sono:
    - valutare la biodisponibilit¿ sistemica di rT3, T3 e TSH, dopo applicazione cutanea della nuova formulazione gel di Somatoline¿ in soggetti femminili
    - valutare la tollerabilit¿ locale e sistemica dopo applicazione cutanea della nuova formulazione gel di Somatoline¿ in soggetti femminili
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Healthy woman will be enrolled in the study if they meet all the following inclusion criteria:
    • Sex and age: Adult women aged between 18 and 50 years;
    • Race: Caucasian;
    • Body mass index (BMI): 18.5 > BMI < 30 kg/m2;
    • Vital signs: systolic blood pressure (SBP) = 100-139 mmHg; diastolic blood pressure (DBP) = 50-89 mmHg; heart rate (HR) = 50-90 bpm, measured after 5 min of rest (sitting position);
    • Electrocardiogram (ECG): no clinically relevant abnormalities at ECG (12 leads);
    • Physical examination: no clinically relevant abnormal physical findings;
    • Laboratory analyses: no clinically relevant abnormal laboratory values indicative of physical illness;
    • Allergy: no ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients or ß lactam antibiotics;
    • Medical history: no history of anaphylaxis to drugs or allergic reactions in general, no relevant history of renal, hepatic, cardiovascular, respiratory, skin, haematological, endocrine, or neurological diseases that may interfere with the aim of the study, no history of gastric mucosal damages, no neoplasia, no medications during 2 weeks before the start of the study, including OTC (“over the counter”);
    • Participation in another experimental trial: no participation in the evaluation of any experimental drug within 3 months prior to screening;
    • Blood donors: no blood donations during 3 months prior to this study;
    • Drug or alcohol history: no history of drug, alcohol (< 1 drink/day for females, defined according to USDA Dietary Guidelines 2000) or tobacco abuse (< 10 cigarettes/day);
    • Pregnancy: not pregnant or lactating (for female healthy subjects);
    • Contraception: fertile women willing to use barrier contraceptive methods;
    • Subjects’ capability: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
    • ICF: signed written ICF prior to inclusion in the study;
    • Life-style: Willingness of the subject to maintain a constant life style during the period of the study.
    Per essere ammessi a questo studio i soggetti devono soddisfare tutti i seguenti criteri:
    • Sesso ed età: donne adulte di età compresa tra 18 e 50 anni;
    • Razza: caucasica;
    • Indice di massa corporea (BMI): 18,5> BMI <30 kg/m2;
    • Segni vitali: pressione arteriosa sistolica (SBP) = 100-139 mmHg; pressione arteriosa diastolica (DBP) = 50-89 mmHg; frequenza cardiaca (HR) = 50-90 bpm, misurata dopo 5 minuti di riposo (posizione seduta);
    • Elettrocardiogramma (ECG): nessuna anomalia clinicamente rilevante all'ECG (12 derivazioni);
    • Esame fisico: nessun riscontro fisico anormale clinicamente rilevante;
    • Analisi di laboratorio: nessun valore di laboratorio anormale clinicamente rilevante indicativo di malattia fisica;
    • Allergia: nessuna ipersensibilità accertata o presunta al principio attivo e / o ingredienti di formulazioni o antibiotici ß lattamici;
    • Anamnesi: nessuna storia di anafilassi ai farmaci o reazioni allergiche in generale, nessuna storia rilevante di patologie renali, epatiche, cardiovascolari, respiratorie, cutanee, ematologiche, endocrine o neurologiche che possano interferire con lo scopo dello studio, nessuna storia di danni della mucosa gastrica, nessuna neoplasia, nessun farmaco durante 2 settimane prima dell'inizio dello studio, incluso OTC ("over the counter");
    • Partecipazione a un'altra sperimentazione sperimentale: nessuna partecipazione alla valutazione di alcun farmaco sperimentale entro 3 mesi prima dello screening;
    • Donatori di sangue: nessuna donazione di sangue durante i 3 mesi precedenti questo studio;
    • Anamnesi farmacologica o alcolica: nessuna storia di droga, alcol (< 1 bevanda al giorno per le donne, definita secondo le linee guida dietetiche USDA 2000) o abuso di tabacco (< 10 sigarette al giorno);
    • Gravidanza: non in gravidanza o in allattamento (per soggetti sani di sesso femminile);
    • Contraccezione: donne fertili che desiderano utilizzare metodi contraccettivi a barriera;
    • Capacità dei soggetti: capacità di comprendere la natura e lo scopo completi dello studio, compresi i possibili rischi ed effetti collaterali; capacità di cooperare con lo sperimentatore e di soddisfare i requisiti dell'intero studio;
    • ICF: firmato ICF scritto prima dell'inclusione nello studio;
    • Stile di vita: disponibilità del soggetto a mantenere uno stile di vita costante durante il periodo di studio.
    E.4Principal exclusion criteria
    Women will be excluded from the study if they meet anyone of the following inclusion criteria:
    • Pregnancy: pregnant or lactating women;
    • ECG: clinically relevant abnormalities;
    • Physical findings: clinically relevant abnormal physical findings which could interfere with the study objectives;
    • Laboratory analyses: clinically relevant abnormal laboratory values indicative of physical illness;
    • Allergy: ascertained or presumptive hypersensitivity to the active principle and/or formulations’ ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considered to potentially affect the outcome of the study;
    • Diseases: relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, haematological, endocrine (in particular, thyroid), or neurological diseases, which may interfere with the aim of the study, history of gastric mucosal damages, neoplasia;
    • Contraceptive: changes (early or suspension) of the use of contraceptive oestrogen-progestin in the last 4 weeks, and inability to take adequate contraception during the study;
    • Medications and diet: any medication, including OTC, is forbidden during the screening period. Moreover:
    - In the 6 months before screening, any treatment with antithyroid drugs or any therapeutic use of iodine or iodine-containing medications (e.g., amiodarone, Somatoline®) is forbidden;
    - In the 6 months before screening, any diagnostic tests that led to the use of tracers, contrast agents containing iodine or iodine isotopes, is forbidden;
    - in the 4 weeks before screening, no changes in diet of foods containing iodine (e.g., iodized salt), or use disinfectants (e.g., betadine), detergents or any systemic or topical product containing iodine, including mouthwashes (e.g., Iodosan), toothpaste iodinated, douches, Lugol's solution;
    - In the 4 weeks before screening, any use of food supplements and herbal medicines;
    - a daily intake of iodized salt < 1,100 µg/day.
    • Investigative drug trials: participation in the evaluation of any experimental drug within 3 months prior to the start of the study;
    • Blood donation: blood donations during the 3 months prior to this study;
    • Drug, alcohol, tobacco: history of drug, alcohol [> 1 drink/day for females defined according to USDA Dietary Guidelines 2000] or tobacco abuse (> 10 cigarettes/day).
    NON saranno ammessi a questo studio i soggetti che presentano almeno uno dei seguenti criteri:
    • Gravidanza: donne in gravidanza o in allattamento;
    • ECG: anormalità clinicamente rilevanti;
    • Risultati fisici: reperti fisici anormali rilevanti dal punto di vista clinico che potrebbero interferire con gli obiettivi dello studio;
    • Analisi di laboratorio: valori anormali di laboratorio clinicamente rilevanti indicativi di malattia fisica;
    • Allergia: ipersensibilità accertata o presunta al principio attivo e / o agli ingredienti delle formulazioni; anamnesi di anafilassi a farmaci o reazioni allergiche in generale, che lo sperimentatore ha considerato potenzialmente in grado di influenzare l'esito dello studio;
    • Malattie: storia rilevante di patologie renali, epatiche, gastrointestinali, cardiovascolari, respiratorie, cutanee, ematologiche, endocrine (in particolare tiroidee) o neurologiche, che possono interferire con lo scopo dello studio, la storia dei danni alla mucosa gastrica, la neoplasia;
    • Contraccettivo: cambiamenti (precoci o sospesi) dell'uso dell'estrogeno-progestinico contraccettivo nelle ultime 4 settimane e incapacità di prendere adeguati contraccettivi durante lo studio;
    • Farmaci e dieta: qualsiasi farmaco, incluso OTC, è vietato durante il periodo di screening. Inoltre:
    - o Nei 6 mesi precedenti lo screening, è vietato qualsiasi trattamento con farmaci antitiroidei o qualsiasi uso terapeutico di iodio o di medicinali contenenti iodio (ad es. amiodarone, Somatoline®);
    - o Nei 6 mesi precedenti lo screening, è vietato qualsiasi test diagnostico che abbia portato all'utilizzo di traccianti, agenti di contrasto contenenti isotopi di iodio o iodio;
    - o nelle 4 settimane prima dello screening, nessun cambiamento nella dieta di alimenti contenenti iodio (ad es. sale iodato) o uso di disinfettanti (ad es. betadine), detergenti o qualsiasi prodotto sistemico
    - o topico contenente iodio, compresi i collutori (ad es. Iodosan), dentifricio iodurato, douches, soluzione di Lugol;
    - o Nelle 4 settimane prima dello screening, qualsiasi uso di integratori alimentari e medicine a base di erbe;
    - o assunzione giornaliera di sale iodato <1.100 µg / giorno.
    • Sperimentazione farmacologica sperimentale: partecipazione alla valutazione di qualsiasi farmaco sperimentale entro 3 mesi prima dell'inizio dello studio;
    • Donazione di sangue: donazioni di sangue durante i 3 mesi precedenti questo studio;
    • Droga, alcol, tabacco: anamnesi di droga, alcool [> 1 bevanda al giorno per le donne definite secondo le linee guida dietetiche USDA 2000] o abuso di tabacco (> 10 sigarette al giorno).
    E.5 End points
    E.5.1Primary end point(s)
    To assess the systemic bioavailability of l-T4.
    Valutare la biodisponibilità sistemica di l-T4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Blood samples for measurement of TSH concentrations will be collected during the Screening (Day -15 to Day 0), Control 1 (Day 0 – Hour 5), Control 2 (Day 1), Control 3 (Day 14) and End of Treatment (Day 28). The assessments will be repeated at End of Study (Day 42) after a 14-day follow-up, during which no treatment will be performed. Apart from the Control 1 assessment, all blood samples will be collected at the same time of the day, with a time window of ± 1 hour.
    Durante lo screening (giorno -15 al giorno 0), controllo 1 (giorno 0 - ora 5), controllo 2 (giorno 1), controllo 3 (giorno 14) e fine del trattamento (Giorno 28) sono raccolti campioni di sangue per la misurazione delle concentrazioni di TSH. La valutazione sarà ripetuta dopo un follow-up di 14 giorni (Giorno 42, fine dello studio), durante il quale non verrà eseguito alcun trattamento. Tranne che per la valutazione di Controllo 1, tutti i campioni di sangue saranno raccolti alla stessa ora del giorno, con una finestra temporale di ± 1 ora.
    E.5.2Secondary end point(s)
    To assess the systemic bioavailability of l-T4 (primary endpoint) and rT3, T3, TSH.; To assess the local and systemic tolerability after repeated cutaneous application of a gel formulation of Somatoline¿.
    Valutare la biodisponibilit¿ sistemica di rT3, T3, TSH.; Valutare la tollerabilit¿ locale e sistemica dopo applicazione cutanea della nuova formulazione gel di Somatoline¿.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Blood samples for measurement of TSH concentrations will be collected during the Screening (Day -15 to Day 0), Control 1 (Day 0 ¿ Hour 5), Control 2 (Day 1), Control 3 (Day 14) and End of Treatment (Day 28). The assessments will be repeated at End of Study (Day 42) after a 14-day follow-up, during which no treatment will be performed. Apart from the Control 1 assessment, all blood samples will be collected at the same time of the day, with a time window of ¿ 1 hour.; Safety of the tested formulation will be evaluated based on the record of any AE and SAE. Moreover, the local tolerability at the application site will be assessed by both the investigator (medical visit) and the subject (diary), throughout the entire study duration.
    Durante lo screening (giorno -15 al giorno 0), controllo 1 (giorno 0 - ora 5), controllo 2 (giorno 1), controllo 3 (giorno 14) e fine del trattamento (Giorno 28) sono raccolti campioni di sangue per la misurazione delle concentrazioni di TSH. La valutazione sar¿ ripetuta dopo un follow-up di 14 giorni (Giorno 42, fine dello studio), durante il quale non verr¿ eseguito alcun trattamento. Tranne che per la valutazione di Controllo 1, tutti i campioni di sangue saranno raccolti alla stessa ora del giorno, con una finestra temporale di ¿ 1 ora.; La sicurezza della formulazione testata sar¿ valutata sulla base della registrazione degli Eventi Avversi Seri e non. Inoltre, la tollerabilit¿ locale presso il sito di applicazione, sar¿ valutata sia dallo sperimentatore (visita medica) che dal sogget
    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 No
    E.6.6Pharmacokinetic Yes
    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
    Local and systemic tolerability.
    Tollerabilit¿ locale e sistemica.
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 months4
    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 months4
    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: 30
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    \
    \
    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 Decision2018-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-13
    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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