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    Summary
    EudraCT Number:2017-002136-16
    Sponsor's Protocol Code Number:RLM-MD-01
    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:2021-02-04
    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 number2017-002136-16
    A.3Full title of the trial
    A 12-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 verso placebo, della durata di 12 settimane, per la valutazione della sicurezza ed efficacia di Relamorelin nei pazienti affetti da gastroparesi diabetica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-week Study to Evaluate the Safety and Efficacy of Relamorelin in Patients with Diabetic Gastroparesis
    Studio di 12 settimane per valutare la sicurezza e ('efficacia di Relamorelin nei pazienti con gastroparesi diabetica
    A.3.2Name or abbreviated title of the trial where available
    Diabetic Gastroparesis Study 1
    Studio 1 sulla gastroparesi diabetica
    A.4.1Sponsor's protocol code numberRLM-MD-01
    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 pointAllergan Ltd EU Regulatory Dept.
    B.5.3 Address:
    B.5.3.1Street AddressParkway, Marlow/ Buckinghamshire
    B.5.3.2Town/ cityMarlow
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number004401628494444
    B.5.5Fax number004401628494449
    B.5.6E-mailml-ct@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.3.9.1CAS 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 mg/ml milligram(s)/millilitre
    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 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 placebo in participants with DG with respect to a composite of the following core signs and symptoms of DG: Nausea, Abdominal pain, Postprandial fullness, Bloating
    - To compare the efficacy of relamorelin with placebo in participants with DG with respect to vomiting frequency
    - Confrontare l'efficacia di relamorelin verso placebo su partecipanti con GD rispetto ai seguenti principali segni e sintomi di GD: nausea, dolore addominale, sazieta postprandiale e gonfiore
    - Confrontare l'efficacia di relamorelin verso placebo su partecipanti con GD rispetto alla frequenza del vomito
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of relamorelin with placebo in participants with DG with respect to the following individual symptoms of the DGSSS: Nausea, Abdominal Pain, Postprandial fullness, Bloating
    - To compare the safety of relamorelin with placebo in participants with DG
    - Confrontare l'efficacia di relamorelin verso placebo su partecipanti con GD rispetto ai seguenti singoli sintomi del DGSSS: nausea, dolore addominale, sazieta postprandiale e gonfiore
    - Confrontare la sicurezza di relamorelin verso placebo su partecipanti con GD
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female participants aged 18 years or older at screening (Visit 1)
    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 1])
    3. HbA1c .11.0% at screening (Visit 1) 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 1) of symptoms on an ongoing basis that are suggestive of GP
    (eg, nausea, abdominal pain, post-prandial 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 1) but after the appearance of symptoms that led to the diagnosis of DG
    7. At least 2 vomiting episodes during the 2 weeks prior to screening (Visit 1), as ascertained by participant history
    8. Delayed GE confirmed by abnormal GEBT, defined as GE half-time (t1 / 2) a 79 minutes at the start of the placebo-controlled Run-in Period (Visit 2). 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 placebo 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 placebo Run-in Period
    13. At least one vomiting episode at any time during the placebo Run-in Period, as recorded in the DGSSD, using the electronic
    hand-held device
    14. The average of the daily DGSSS from the 2-week, placebo Run-in Period must be >= a 16
    1. Partecipanti di sesso maschile e femminile di eta pad o superiore ai 18 anni allo screening (Visita 1)
    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 (per
    es., nessun episodio di chetoacidosi diabetica, sindrome diabetica iperglicemica iperosmolare non chetosica, o ipoglicemia grave
    nei 6 mesi precedenti lo screening [Visita 1])
    3. Emoglobina glicata (HbA1c) .11,0% allo screening (Visita 1) 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 precedente allo screening
    (Visita 1) di sintomi su base continuativa, che sono indicativi di GP (per es., nausea, dolore addominale, senso di pienezza
    postprandiale, gonfiore addominale, vomito, e sazieta 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 6 idonea a partecipare se non 6 incinta (ha un risultato
    negativo al test di gravidanza sulle urine prima della randomizzazione), non allatta al seno e rispetta almeno una delle seguenti
    condizioni:
    a. Non 6 una donna in eta fertile (Woman of childbearing potential, WOCBP)
    OPPURE
    b. E 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 del tratto digerente superiore o altri test diagnostici,
    effettuati in un periodo precedente allo screening (Visita 1) ma dopo la comparsa dei sintomi che hanno portato
    alla diagnosi di DG
    7. Almeno 2 episodi di vomito nelle 2 settimane precedenti lo screening (Visita 1), in base a quanto accertato dall'anamnesi del
    partecipante
    8. Svuotamento gastrico (GE) ritardato, confermato dal tempo di svuotamento gastrico mediante test del respiro (Gastric emptying breath test, GEBT) anomalo, definito come meta tempo di GE (t%) di a 79 minuti all'inizio del periodo di run-in controllato con placebo (Visita 2). Nei Paesi in cui il GEBT non 6 disponibile, il GE ritardato pub essere confermato da risultati anomali di scintigrafia (ritenzione > 60% a 2 ore o > 10% a 4 ore)
    9. BMI > 18,5 kg/m2
    10. Soggetto in grado di fornire consenso informato scritto (IC) prima dell'esecuzione di qualsiasi procedura dello studio e disposto e in grado di attenersi alle procedure dello studio
    Ulteriori criteri di inclusione per la randomizzazione dopo il periodo di run-in con placebo di 2 settimane:
    11. Conformity con l'immissione di dati nel dispositivo elettronico portatile in Imeno 10 dei 14 giorni durante il periodo di run-in
    con placebo
    12. Conformity con la somministrazione di iniezioni s.c. due volte al giorno, come evidenziato dai dati inseriti dal partecipante
    usando il dispositivo elettronico portatile, in occasione di almeno 10 dei 14 giorni durante il periodo di run-in con placebo
    13. Almeno un episodio di vomito in qualsiasi momento durante il periodo di run-in con placebo, secondo quanto registrato nel
    Diario della gravity dei sintomi della gastroparesi diabetica (Diabetic Gastroparesis Symptom Severity Diary DGSSD), utilizzando il
    dispositivo manuale elettronico 14. La media del Punteggio giornaliero della gravity dei sintomi della gastroparesi diabetica
    (DGSSS) dal periodo di run-in con placebo di 2 settimane deve essere >= a 16
    E.4Principal exclusion criteria
    1. Symptomatic Irritable Bowel Syndrome at Screening (Visit 1)
    2. Small intestinal bacterial overgrowth (SIBO) at Screening (Visit 1)
    3. History of anorexia nervosa, binge-eating, bulimia, or other eating disorder within 5 years of screening (Visit 1)
    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
    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 2)
    12. Positive results on the urine drug screen at Screening (Visit 1). The significance of a positive screen result for drugs prescribed
    for the participant (e.g., 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 opioids, or expecting to use opioids 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 2)
    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 tud articipation in such a study within 30 days of entry into this
    study
    20. Allergic to, or intolerant of egg, wheat, milk, or algae, a these are components of the GEBT study meal
    21. Females who are pregnant, nursing, or planning a pregnancy during the study
    22. The participant has a condition or is in a situation which, in the investigator's opinion, may put the participant at significant
    risk, may confound the study results, or may interfere significantly with the participant's participation in the study
    23. Participant is directly or indirectly involved in the conduct and administration of this study as an investigator, subinvestigator,
    study coordinator, other study staff member, or employee of Allergan, Inc.; or the participant is a first-degree family member,
    significant other, or relative residing with one of the above persons involved directly or indirectly in the study; or the participant is
    enrolled in this study at another clinical study site
    24. Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
    1. Sindrome dell'intestino irritabile sintomatica allo screening (Visita 1)
    2. Sindrome da contaminazione batterica dell'intestino tenue (Small intestinal bacterial overgrowth, SIBO) allo screening (Visita 1)
    3. Anamnesi di anoressia nervosa, binge-eating, bulimia, o altro disturbo del comportamento alimentare entro 5 anni dallo
    screening (Visita 1)
    4. Anamnesi di malassorbimento intestinale (tra cui malattia celiaca anche se ben controllata con una diets priva di glutine) o
    insufficienza pancreatica esocrina; inoltre, anamnesi di sensibility 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) a 3 volte il
    limite superiore della normality (Upper limit of normal, ULN), e/o bilirubina diretta a 2 volte I'ULN
    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-motility gastrointestinale per almeno 10 giorni prima dell'inizio del periodo di run-in (Visita 2)
    12. Risultati positivi del test farmacologico sulle urine allo screening (Visita 1). La significativita 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 valutare se l'utilizzo della loro dose stabile sia clinicamente appropriato, e, pertanto, non dovrebbe
    essere un criterio di esclusione; l'uso di questi farmaci in base alle necessity non a consentito
    13. Attuale assunzione di oppioidi, o previsto utilizzo di oppioidi 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 2)
    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 a un criterio di esclusione)
    17. Randomizzazione a uno studio precedente in cui relamorelin a stato un trattamento
    18. Velocity 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
    21. Donne in stato di gravidanza, che allattano al seno, o che stanno pianificando una gravidanza durante lo studio
    22. II partecipante ha una patologia o si trova in una situazione che, a giudizio dello sperimentatore, potrebbe comportare un
    rischio significativo per il partecipante, confondere i risultati dello studio, o interferire significativamente con la
    sua partecipazione allo studio
    Per altri criteri fare riferimento al Protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    - The Diabetic Gastroparesis Symptom Severity Score (DGSSS) Responder, defined as a participant who has a L. 10-point improvement in the DGSSS compared to baseline in each of the last 6 weeks of the 12-week Treatment Period
    - Vomiting Responder, defined as a participant who reports no vomiting episodes during each of the last 6 weeks of the 12-week Treatment Period
    - Paziente responder al Punteggio della gravita dei sintomi di gastroparesi diabetica (DGSSS), definito come un partecipante che ha un miglioramento di L. 10 punti nel DGSSS rispetto al basale in ciascuna delle ultime 6 settimane del periodo di trattamento di 12 settimane
    - Paziente responder al vomito, definito come un partecipante che non riporta alcun episodio di vomito durante ciascuna delle
    ultime 6 settimane del periodo di trattamento di 12 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each of the last 6 weeks of the 12-week Treatment Period
    Ognuna delle ultime 6 settimane del periodo di trattamento di 12 settimane
    E.5.2Secondary end point(s)
    - Individual Symptom (ie, nausea, abdominal pain, postprandial fullness, and bloating) Responder, defined as a participant with at least a 2-point decrease in the change from baseline on the weekly average of the symptom severity (at its worst) during each of the last 6 weeks of the 12-week
    Treatment Period - AEs, clinical laboratory values, vital signs, ECGs, HbA1c, and antirelamorelin antibodies
    - Paziente responder ai singoli sintomi (ovvero nausea, dolore addominale, pienezza postprandiale e gonfiore), definito come un partecipante con una diminuzione di almeno 2 punti della variazione rispetto al basale nella media
    settimanale del punteggio della gravita dei sintomi (nel momento peggiore) durante ciascuna delle ultime 6 settimane del periodo di trattamento di 12 settimane
    - EA, valori clinici di laboratorio, segni vitali, ECG, HbA1c, e anticorpi antirelamorelin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each of the last 6 weeks of the 12-week Treatment Period
    Ognuna delle ultime 6 settimane del periodo di trattamento di 12 settimane
    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 EEA113
    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
    India
    Israel
    Korea, Republic of
    Malaysia
    Philippines
    Saudi Arabia
    Singapore
    Thailand
    Ukraine
    United Arab Emirates
    Bulgaria
    France
    Italy
    Poland
    Spain
    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 conclusione della sperimentazione a definita come la data dell'ultima visits dell'ultimo partecipante allo studio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 1875
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 625
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 175
    F.4.2.2In the whole clinical trial 2500
    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 successfully complete this study are eligible to enter a placebo-controlled, long-term safety and efficacy study (LTSES) (RLM-MD-03) during which they will receive study treatment for an additional 46 weeks.
    I partecipanti the hanno completato con successo la sperimentazione sono eleggibili per accedere allo studio sulla sicurezza ed efficacia a lungo termine controllato con placebo (LTSES) (RLM-MD-03) durante it quale riceveranno it trattamento in studio per ulteriori 46 settimane.
    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 Decision2019-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-18
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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