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    Summary
    EudraCT Number:2017-002144-33
    Sponsor's Protocol Code Number:RLM-MD-04
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-09-02
    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 number2017-002144-33
    A.3Full title of the trial
    A 52-week, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    Studio di fase 3 randomizzato, in doppio cieco, controllato con placebo della durata di 52 settimane per valutare la sicurezza e l'efficacia di Relamorelin in pazienti con gastroparesi diabetica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 52-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    Studio di 52 settimane per valutare la sicurezza e l'efficacia di Relamorelin in pazienti con gastroparesi diabetica
    A.3.2Name or abbreviated title of the trial where available
    Diabetic Gastroparesis Study 4
    Studio 4 sulla gastroparesi diabetica
    A.4.1Sponsor's protocol code numberRLM-MD-04
    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 SponsorALLERGAN LIMITED
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan Ltd.
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointNick Connolly
    B.5.3 Address:
    B.5.3.1Street AddressMarlow, International, Parkway
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441628494387
    B.5.5Fax number00441628494887
    B.5.6E-mailConnolly_Nick@allergan.com
    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 nameRelamorelin
    D.3.2Product code [RM-131]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRelamorelin
    D.3.9.1CAS number 661472-41-9
    D.3.9.2Current sponsor codeRM-131
    D.3.9.4EV Substance CodeSUB182309
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Gastroparesis
    Gastroparesi diabetica
    E.1.1.1Medical condition in easily understood language
    Diabetic Gastroparesis
    Gastroparesi diabetica
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10051153
    E.1.2Term Diabetic gastroparesis
    E.1.2System Organ Class 10017947 - Gastrointestinal 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 compare the efficacy of relamorelin with that of placebo in participants with DG with respect to: DGSSS, Individual symptoms of DGSSS (Nausea, Abdominal pain, Postprandial fullness, Bloating), Vomiting Frequency
    - Confrontare l'efficacia di relamorelin con quella del placebo in partecipanti con GD in relazione a: DGSSS, sintomi individuali di DGSSS (nausea, dolore addominale, pienezza postprandiale, gonfiore)
    E.2.2Secondary objectives of the trial
    - To compare the safety of relamorelin with that of placebo in participants with DG
    - Confrontare la sicurezza di relamorelin con quella del placebo in partecipanti con GD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Rollover Participants:
    Participants who were not randomization-eligible at the end of the Run-in Period of lead-in Studies RLM-MD-01 or RLM-MD-02 are eligible to be randomized in the study if all of the following criteria apply:
    In the lead-in studies, participants must have met all Screening Visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the DGSSD) except that:
    1. They had zero vomiting episodes and an average daily DGSSS of = 12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device;
    OR
    2. They had vomiting episodes and an average daily DGSSS of = 12 but < 16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device.

    De Novo Participants
    Participants who undergo screening and run-in procedures for Study RLM MD-04 are eligible to be included in the study if all of the following criteria apply:
    1. Male or female participants aged 18 years or older at Screening (Visit –2)
    2. T1DM or T2DM of at least 5 years’ duration, with controlled and stable blood glucose levels (ie, no episodes of diabetic ketoacidosis, Hyperosmolar Hyperglycemic Nonketotic Diabetic Syndrome, or severe hypoglycemia within the 6 months preceding Screening [Visit –2])
    3. HbA1c = 11.0% at Screening (Visit –2) in participants being treated with oral and/or parenteral medications for T1DM or T2DM with the goal of achieving controlled and stable glucose levels
    4. DG defined as at least a 3-month history prior to Screening (Visit –2) of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of GP (eg, nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety)
    5. Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and Follow-up Period
    A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization, not breastfeeding, and at least one of the following conditions applies:
    a. Not a woman of childbearing potential (WOCBP)
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance during the Treatment Period and for at least 7 days after the last dose of study treatment
    6. Documentation of absence of an obstructing lesion on upper endoscopy or other equivalent diagnostic test, performed at some time before Screening (Visit –2) but after the appearance of symptoms that led to the diagnosis of DG
    7. Nausea and/or at most a single episode of vomiting during the 2 weeks prior to Screening (Visit –2), as ascertained by participant history
    8. Delayed GE confirmed by abnormal GEBT, defined as GE half-time (t½) = 79 minutes at the start of the placebo-controlled Run-in Period (Visit 2 of RLM-MD-01, RLM-MD-02, or this study). In countries where the GEBT is not available, delayed GE may be confirmed by abnormal scintigraphy result (> 60% retention at 2 hours or > 10% at 4 hours)
    9. BMI > 18.5 kg/m2
    10. Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures
    Additional inclusion criteria for randomization after the 2-week, placebo Run-in Period:
    11. Compliance with the entry of data into the hand-held electronic device on at least 10 of 14 days during the Run-in Period
    12. Compliance with administration of SC twice daily injections, as evidenced by entries made by the participant using the electronic, hand-held device on at least 10 of 14 days during the Run-in Period
    13. The average of the daily DGSSS from the 2-week, Run-in Period must be = 12
    Partecipanti al rollover:
    I partecipanti che non sono stati ritenuti idonei alla randomizzazione alla fine del periodo di run-in degli studi preliminari RLM-MD-01 o RLM-MD-02 sono idonei a essere randomizzati nello studio se soddisfano tutti i seguenti criteri:
    Negli studi preliminari, i partecipanti devono aver soddisfatto tutti i criteri delle visite di screening e del periodo di run-in per la randomizzazione nel periodo di trattamento (inclusa la conformità con la somministrazione, l’inserimento dei dati nel Diario della gravità dei sintomi della gastroparesi diabetica (Diabetic Gastroparesis Symptom Severity Diary, DGSSD) salvo che:
    1. Abbiano avuto zero episodi di vomito e una media del Punteggio giornaliero della gravità dei sintomi della gastroparesi diabetica (DGSSS) = 12 alla fine del periodo di run-in dello studio preliminare, come segnalato utilizzando il dispositivo elettronico portatile;
    OPPURE
    2. Abbiano avuto episodi di vomito e una media giornaliera di DGSSS = 12 ma < 16 alla fine del periodo di run-in dello studio preliminare, come segnalato utilizzando il dispositivo elettronico portatile.
    Partecipanti de novo
    I partecipanti che si sottopongono a procedure di screening e preliminari per lo studio RLM MD-04 sono idonei ad essere inclusi nello studio se soddisfano tutti i seguenti criteri:
    1. Partecipanti di sesso maschile o femminile di età pari o superiore ai 18 anni allo screening (Visita -2)
    2. Diabete mellito di tipo 1 (DMT1) o di tipo 2 (DMT2) da almeno 5 anni, con livelli di glicemia nel sangue controllati e stabili (ovvero, nessun episodio di chetoacidosi diabetica, sindrome diabetica iperosmolare iperglicemica non chetosica, o ipoglicemia grave nei 6 mesi precedenti lo Screening [Visita –2])
    3. Emoglobina glicata (HbA1c) = 11,0% allo screening (Visita -2) nei partecipanti in trattamento con farmaci per via orale e/o parenterale per DMT1 o DMT2 con l’obiettivo di ottenere livelli di glicemia controllati e stabili
    4. Gastroparesi diabetica (Diabetic gastroparesis, DG) definita come un’anamnesi di almeno 3 mesi prima dello screening (Visita -2) di sintomi (uno dei quali deve essere nausea) su base continuativa, che sono indicativi di GP (ad es., nausea, dolore addominale, senso di pienezza postprandiale, gonfiore addominale, vomito, e sazietà precoce)
    5. Partecipanti di sesso femminile disposte a ridurre al minimo il rischio di iniziare una gravidanza per tutta la durata dello studio clinico e del periodo di follow-up Una partecipante di sesso femminile è idonea a partecipare se non è incinta (ha un risultato negativo al test di gravidanza sulle urine prima della randomizzazione, non allatta al seno, e soddisfa almeno una delle seguenti condizioni:
    a. Non è una donna in età fertile ((Woman of childbearing potential, WOCBP)
    OPPURE
    b. È una WOCBP che accetta di seguire le linee guida in materia di contraccezione durante il periodo di trattamento e per almeno 7 giorni dopo l’ultima dose di trattamento dello studio
    6. Documentazione di assenza di una lesione ostruttiva su endoscopia superiore o altri test diagnostici, effettuata in un periodo precedente allo screening (Visita -2) ma dopo la comparsa dei sintomi che hanno portato alla diagnosi di DG
    7. Nausea e/o tutt’al più un singolo episodio di vomito nelle 2 settimane precedenti lo screening (Visita -2), in base a quanto accertato dall’anamnesi del partecipante
    8. Svuotamento gastrico ritardato (Gastric emptying, GE) confermato dal tempo di svuotamento gastrico mediante test del respiro (Gastric emptying breath test, GEBT) anomalo, definito come metà tempo di GE (t½) di = 79 minuti all’inizio del periodo di run-in controllato con placebo (Visita 2 di RLM-MD-01, RLM-MD-02, o di questo studio). Nei Paesi in cui il GEBT non è disponibile, il GE ritardato può essere confermato da risultati anomali di scintigrafia (ritenzione > 60% a 2 ore o > 10% a 4 ore)
    Si prega di fare riferimento al protocollo per altri criteri di inclusione
    E.4Principal exclusion criteria
    Rollover Participants
    Participants will be excluded from this study if any of the lead-in study exclusion criteria apply at Screening (Visit 1) and at the end of the Run-in Period (Visit 3) for randomization into the Treatment Period of Studies RLM MD 01 and RLM MD-02, except as specified in the inclusion criteria
    De Novo Participants
    1. Symptomatic Irritable Bowel Syndrome at Screening (Visit –2)
    2. Small intestinal bacterial overgrowth (SIBO) at Screening (Visit –2)
    3. History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of Screening (Visit –2)
    4. History of intestinal malabsorption (including celiac disease even if well-controlled on a gluten-free diet) or pancreatic exocrine insufficiency; also, history of non-celiac gluten sensitivity
    5. History of belching disorders, other nausea and vomiting disorders (eg, chronic nausea and vomiting syndrome, cyclic vomiting syndrome, cannabinoid hyperemesis syndrome), or rumination syndrome
    6. History of chronic obstructive pulmonary disease or other causes of pulmonary dysfunction that have resulted in CO2 retention
    7. Gastric or duodenal ulcer within 3 months of Screening (Visit 1)
    8. Evidence of hepatic disease defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 3 x ULN, and/or direct bilirubin = 2 x ULN at Screening (Visit 2)
    9. History of malignancy in the 3 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
    10. Currently receiving parenteral feeding or presence of a nasogastric or other enteral tube for feeding or decompression
    11. Use of metoclopramide, domperidone, prucalopride, macrolide antibiotics (eg, erythromycin, clarithromycin, azithromycin), or other drugs considered to be GI pro-motility agents for at least 10 days prior to the start of the Run-in Period (Visit –1)
    12. Positive results on the urine drug screen will exclude participants from participating in the study. The significance of a positive screen result for drugs prescribed for the participant (eg, barbiturates, benzodiazepines, amphetamines, but not cannabinoids) should be assessed by the Investigator as to whether their stable-dose usage is clinically appropriate, and, therefore, should not be exclusionary; use of these drugs on an as-needed basis is not allowed
    13. Currently taking opiates, or expecting to use opiates during the course of the clinical study.
    14. Treatment with glucagon-like peptide-1 (GLP-1) agonist for at least 6 weeks prior to the start of the Run-in Period (Visit –1)
    15. History of pyloric injection of botulinum toxin within 6 months of screening
    16. History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, or bariatric procedure (a history of diagnostic endoscopy is not exclusionary)
    17. Randomization in any previous study in which relamorelin was a treatment
    18. Estimated glomerular filtration rate (eGFR) of < 30 mL/min
    19. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
    20. Allergic to, or intolerant of egg, wheat, milk, or algae, as these are components of the GEBT study meal
    Please refer to the protocol for further exclusion criteria.
    Partecipanti al rollover
    I partecipanti saranno esclusi da questo studio se soddisfano uno qualsiasi dei criteri di esclusione di questo studio preliminare allo screening (Visita 1) e alla fine del periodo di run-in (Visita 3) per la randomizzazione nel periodo di trattamento degli studi RLM MD 01 e RLM MD-02, ad eccezione di quanto specificato nei criteri di inclusione
    Partecipanti de novo
    1. Sindrome dell’intestino irritabile sintomatica allo screening (Visita -2)
    2. Sindrome da contaminazione batterica dell’intestino tenue (Small intestinal bacterial overgrowth, SIBO) allo screening (Visita -2)
    3. Anamnesi di anoressia nervosa, binge-eating, bulimia, o altro disturbo del comportamento alimentare entro 5 anni dallo screening (Visita -2)
    4. Anamnesi di malassorbimento intestinale (tra cui malattia celiaca anche se ben controllata con una dieta priva di glutine) o insufficienza pancreatica esocrina; inoltre, anamnesi di sensibilità al glutine non celiaca
    5. Anamnesi di disturbi di eruttazione, altri disturbi di nausea e vomito (per es., sindrome di nausea e vomito cronici, sindrome del vomito ciclico, sindrome di iperemesi da cannabinoidi) o sindrome di ruminazione
    6. Anamnesi di malattia polmonare ostruttiva cronica o di altre cause di disfunzione polmonare che abbiano comportato ritenzione di CO2
    7. Ulcera gastrica o duodenale nei 3 mesi precedenti lo screening (Visita 1)
    8. Evidenza di malattia epatica, definita da valori di alanina aminotransferasi (ALT) o aspartato aminotransferasi (AST) = 3 volte il limite superiore della normalità (Upper limit of normal, ULN), e/o bilirubina diretta = 2 volte l’ULN allo screening (Visita 2)
    9. Anamnesi di tumore maligno nei 3 anni precedenti alla Visita 1, fatta eccezione per carcinoma cutaneo basocellulare o squamocellulare, o carcinoma della cervice in situ adeguatamente trattati
    10. Soggetti che attualmente ricevono nutrizione parenterale o presenza di un sondino nasogastrico o altri sondini enterali per nutrizione o decompressione
    11. Uso di metoclopramide, domperidone, prucalopride, antibiotici macrolidi (per es., eritromicina, claritromicina, azitromicina) o altri farmaci considerati agenti pro-motilità gastrointestinale per almeno 10 giorni prima dell’inizio del periodo di run-in (Visita -1)
    12. Risultati positivi del test farmacologico sulle urine escluderanno i partecipanti dalla partecipazione allo studio. La significatività di un risultato positivo del test per i farmaci prescritti per il partecipante (per es., barbiturici, benzodiazepine, anfetamine, ma non cannabinoidi) deve essere valutata dallo sperimentatore per stabilire se l’utilizzo della loro dose stabile sia clinicamente appropriato, e, pertanto, se non debba essere un criterio di esclusione; l’uso di questi farmaci in base alle necessità non è consentito
    13. Attuale assunzione di oppiacei, o previsto uso di oppiacei durante il corso dello studio clinico.
    14. Trattamento con agonista del glucagon-like peptide-1 (GLP-1) per almeno 6 settimane prima dell’inizio del periodo di run-in (Visita -1)
    15. Anamnesi di iniezione pilorica di tossina botulinica entro 6 mesi dallo screening
    16. Anamnesi di chirurgia gastrica come fundoplicatio, gastrectomia, posizionamento di pacemaker gastrico, vagotomia, o procedura bariatrica (un’anamnesi di endoscopia diagnostica non è un criterio di esclusione)
    17. Randomizzazione a uno studio precedente in cui relamorelin è stato un trattamento
    18. Velocità di filtrazione glomerulare stimata (Estimated glomerular filtration rate, eGFR) < 30 ml/min
    19. Attuale arruolamento in uno studio su un dispositivo o un farmaco sperimentale o partecipazione a tale studio entro 30 giorni dall’ingresso a questo studio
    20. Reazioni allergiche o intolleranza a uova, frumento, latte, o alghe, in quanto questi sono i componenti del pasto dello studio GEBT
    Fare riferimento al protocollo per altri criteri di esclusione.
    E.5 End points
    E.5.1Primary end point(s)
    - DGSSS Week 12 Responder
    - Vomiting Frequency Week 12 Responder
    - DGSSS Week 52 Responder
    - Vomiting Frequency Week 52 Responder
    - Nausea Week 12 Responder
    - Abdominal Pain Week 12 Responder
    - Bloating Week 12 Responder
    - Postprandial Fullness Week 12 Responder
    - Change from baseline to Week 52 in average weekly DGSSS
    - Change from baseline to Week 52 in average weekly number of vomiting episodes
    - Risponder al DGSSS alla Settimana 12
    - Frequenza del vomito alla Settimana 12
    - Risponder al DGSSS alla Settimana 52
    - Risponder alla nausea alla Settimana 12
    - Risponder ai dolori addominali alla Settimana 12
    - Responder al vomito alla Settimana 12
    - Responder alla pienezza postprandiale alla Settimana 12
    - Variazione del DGSSS settimanale medio alla Settimana 52 rispetto al basale
    - Variazione del numero settimanale medio di episodi di vomito alla Settimana 52 rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    - week 12
    - week 52
    - Settimana 12
    - Settimana 52
    E.5.2Secondary end point(s)
    - Adverse events (AEs), clinical laboratory values, vital signs, electrocardiograms (ECGs), hemoglobin A1c (HbA1c), and anti-relamorelin antibodies
    - Eventi avversi (EA), valori clinici di laboratorio, segni vitali, elettrocardiogramma (ECG), emoglobina A1c (HbA1c) e anticorpi anti-relamorelin
    E.5.2.1Timepoint(s) of evaluation of this end point
    The whole study duration
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned15
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA174
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Colombia
    India
    Israel
    Korea, Republic of
    Malaysia
    Mexico
    Philippines
    Russian Federation
    Saudi Arabia
    Singapore
    South Africa
    Taiwan
    Thailand
    Ukraine
    United Arab Emirates
    Austria
    Belgium
    Bulgaria
    Denmark
    France
    Germany
    Hungary
    Italy
    Latvia
    Poland
    Romania
    Spain
    United Kingdom
    Argentina
    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 study is defined as the date of the last visit of the last participant in the study.
    La fine dello studio e' definita come la data dell'ultima visita dell'ultimo partecipante allo studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days25
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days25
    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: 450
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 Yes
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 328
    F.4.2.2In the whole clinical trial 600
    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)
    Participants who complete the study should follow up with the investigator regarding treatment at the end of the study.
    I partecipanti che hanno completato lo studio dobrebbero seguire lo sperimentatore per quanto riguarda il trattamento alla fine dello studio.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Network, UK
    G.4.3.4Network Country United Kingdom
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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