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    Summary
    EudraCT Number:2011-003051-19
    Sponsor's Protocol Code Number:Z7190M01
    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:2011-12-28
    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 number2011-003051-19
    A.3Full title of the trial
    Evaluation of the speed of action of Ibuprofen Arginine in comparison to Ibuprofen in the acute pain relief after mini invasive orthopaedic arthroscopic knee surgery in adults.
    Valutazione della velocita' di azione di Ibuprofene Arginina rispetto a Ibuprofene nell'alleviare il dolore acuto dopo chirurgia artroscopica ortopedica mini-invasiva del ginocchio in pazienti adulti.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to demonstrate that Ibuprofen Arginine acts more quickly than Ibuprofen in relieving acute pain after knee surgery.
    Studio volto a dimostrare che Ibuprofene Arginina agisce piu' rapidamente rispetto ad Ibuprofene nell'alleviare il dolore acuto dopo intervento chirurgico al ginocchio.
    A.4.1Sponsor's protocol code numberZ7190M01
    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 SponsorZAMBON S.p.A.
    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 supportZambon S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZambon S.p.A.
    B.5.2Functional name of contact pointSponsor Contact Person
    B.5.3 Address:
    B.5.3.1Street AddressVia Lillo del Duca, 10
    B.5.3.2Town/ cityBresso (Milano)
    B.5.3.3Post code20091
    B.5.3.4CountryItaly
    B.5.4Telephone number+39.026652.4513
    B.5.5Fax number+39.026652.4841
    B.5.6E-mailmassimo.bagolan@zambongroup.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 Yes
    D.2.1.1.1Trade name SPIDIFEN*OS GRAT 30BUST 600MG
    D.2.1.1.2Name of the Marketing Authorisation holderZAMBON ITALIA Srl
    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.3.4Pharmaceutical form Effervescent granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15687-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BRUFEN*OS GRAT 30BUST 600MG
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT Srl
    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.3.4Pharmaceutical form Effervescent granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15687-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 SPIDIFEN*GRAT 8BUST 600MG
    D.2.1.1.2Name of the Marketing Authorisation holderZAMBON ITALIA Srl
    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.3.4Pharmaceutical form Effervescent granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15687-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 4
    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 BRUFEN*OS GRAT 10BUST 600MG
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT Srl
    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.3.4Pharmaceutical form Effervescent granules
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15687-27-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Postoperative acute pain.
    Dolore acuto post-operatorio.
    E.1.1.1Medical condition in easily understood language
    Pain after surgery.
    Dolore dopo intervento chirurgico.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10027289
    E.1.2Term Meniscectomy (knee)
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the speed of action and global clinical efficacy of IBA in comparison with IBU in patients with postoperative acute pain.
    Determinare la velocità d’azione e l’efficacia clinica globale di IBA in confronto a IBU in pazienti con dolore acuto post-operatorio.
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Male or female patients aged ≥ 18 and ≤ 65 years; 2)Patients undergoing to mini invasive orthopaedic surgery (meniscectomy) in loco-regional anaesthesia; 3)Patients having a pain intensity of 50 or more on a 0-100 VAS in the post-surgical period; 4)American Society of Anaesthesiologists (ASA) physical status I and II for the whole study duration; 5)Signed informed consent; 6)Willing and able to comply with study procedures.
    1)Pazienti uomini e donne di età &gt;18 e &lt;65 anni 2)Pazienti che devono sottoporsi a chirurgia ortopedica mini-invasiva (meniscectomia) in anestesia loco-regionale 3)Pazienti che presentano un’intensità del dolore pari a 50 o superiore su una scala VAS 0-100 nel periodo post-chirurgico 4)Stato fisico I e II secondo ASA (Am. Soc. of Anaesthesiologists) per tutta la durata dello studio 5)Firma del Consenso Informato; 6)Intenzionati e in grado di rispettare le procedure dello studio.
    E.4Principal exclusion criteria
    1)Ascertained or presumptive hypersensitivity to the active compound and/or any of the formulation excipients; 2)History of anaphylaxis to drugs or allergic reactions; in particular, history of hypersensitivity reactions (e.g. bronchospasm, rhinitis, urticaria, angioedema) to non-steroidal anti-inflammatory drugs (NSAIDs); 3)Obstructive respiratory syndromes (asthma or COPD), nasal polyposis or any other chronic respiratory disease; 4)History of psychosis (e.g. schizophrenia or psychotic depression) or major depression (requiring treatment); 5)Severe neurological diseases, including dementia, anxiety, mental retardation, multiple sclerosis, Parkinson’s disease, uncontrolled epilepsy; 6)Transient ischemic attack or cerebrovascular accident within the last three months before the screening visit; 7)Myocardial infarction, unstable angina, arrhythmias, cardiac failure or other chronic cardiac diseases; 8)Significant kidney (serum creatinine ≥ 2.0 mg/dL or 180 µmol/L) or liver disease (serum transaminases ≥ 3 x upper limit of normal); 9)History of gastrointestinal diseases, active peptic ulcer, gastrointestinal bleeding in the preceding 6 months before the screening visit; 10)Inflammatory Bowel Diseases (IBD); 11)Phenylchetonuria; 12)Autoimmune diseases; 13)Blood coagulation disorders or anticoagulants use within the last month before the screening visit; 14)Symptomatic osteoarthritis requiring medical therapy or inflammatory arthritis; 15)Arthroscopic knee surgery within the last 6 months before the screening visit; 16)Body mass index (BMI) ≥ 35 kg/m2; 17)Use of paracetamol within 24 hours before the randomization visit; 18)Use of muscle relaxants 24 hours before the randomization visit; 19)Use of systemic and topical preparations of NSAIDs within 48 hours before the randomization visit; 20)Use of opioids within 7 days before the randomization visit; 21)Use of systemic and topical preparations of corticosteroids within 14 days before the randomization visit; 22)Any clinical significant abnormal laboratory values as judged by the Investigator; 23)Pregnant or lactating women or women of childbearing age not using a reliable method of contraception (hormonal oral, implantable, transdermal, or injectable contraceptives for at least 2 months prior to the screening visit; a non-hormonal intrauterine device [IUD] with spermicide), or in postmenopausal status for less than 2 years; 24)Intake of investigational drug within the last 30 days before the screening visit; 25)History of alcohol or drug abuse; 26)Donation of blood in the previous 3 months before the screening visit; 27)Inadequate comprehension of study risks and requirements, or uncooperative patient; 28)Any other clinical condition or disease or history of significant diseases which, in the opinion of the Investigator, makes the subject inappropriate for the study.
    1)Ipersensibilità accertata o presunta al composto attivo e/o a qualunque eccipiente della formulazione. 2)Anamnesi di anafilassi ai farmaci o reazioni allergiche; in particolare, anamnesi di reazioni di ipersensibilità (ad es., broncospasmo, rinite, orticaria, angioedema) a farmaci anti-infiammatori non steroidei (FANS). 3)Sindromi respiratorie ostruttive (asma o BPCO), poliposi nasale o altra malattia respiratoria cronica. 4)Anamnesi di psicosi (ad es., schizofrenia o depressione psicotica) o depressione maggiore (che richiede trattamento). 5)Malattie neurologiche gravi, compresa demenza, ansia, ritardi mentali, sclerosi multipla, morbo di Parkinson, epilessia non controllata. 6)Attacco ischemico transitorio o accidente cerebrovascolare negli ultimi tre mesi prima della visita di screening. 7)Infarto miocardico, angina instabile, aritmie, insufficienza cardiaca o altre malattie cardiache croniche. 8)Significativa nefropatia (creatinina sierica &gt;2,0 mg/dl o 180 mcrmol/l) o epatopatia (transaminasi sieriche &gt;3 volte il limite superiore alla norma). 9)Anamnesi di malattie gastrointestinali, ulcera peptica attiva, emorragia gastrointestinale nei 6 mesi precedenti la visita di screening. 10)Malattie infiammatorie intestinali (IBD). 11)Fenilchetonuria. 12)Malattie autoimmuni. 13)Difetti di coagulazione del sangue o uso di anticoagulanti nell’ultimo mese prima della visita di screening. 14)Osteoartrite sintomatica che richiede terapia medica o artrite infiammatoria. 15)Artroscopia chirurgica del ginocchio negli ultimi 6 mesi prima della visita di screening. 16)Indice di Massa Corporea &gt; 35 kg/m2 17)Uso di paracetamolo nelle 24 ore prima della visita di randomizzazione. 18)Uso di miorilassanti 24 ore prima della visita di randomizzazione 19)Uso di preparati topici e sistemici di FANS nelle 48 ore prima della visita di randomizzazione. 20)Uso di oppioidi nei 7 giorni prima della visita di randomizzazione. 21)Uso di preparati topici e sistemici a base di corticosteroidi nei 14 giorni prima della visita di randomizzazione. 22)Tutti i valori clinici di laboratorio anomali significativi a giudizio dello sperimentatore. 23)Donne incinta o in allattamento o donne in età fertile che non usano un affidabile metodo di contraccezione (ormonale orale, impiantabile, transdermico, o contraccettivi iniettabili per almeno 2 mesi prima della visita di screening; dispositivo intrauterino non ormonale con spermicida) o in post-menopausa da meno di 2 anni. 24)Assunzione di farmaco sperimentale negli ultimi 30 giorni prima della visita di screening. 25)Anamnesi di alcolismo o abuso di droghe. 26)Donazione di sangue nei 3 mesi precedenti la visita di screening. 27)Comprensione inadeguata dei rischi e dei requisiti dello studio, paziente non collaborativo. 28)Qualunque altra condizione clinica o malattia o anamnesi di malattie significative che, a opinione dello Sperimentatore, rendano il soggetto inadeguato per lo studio.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the clinical efficacy of the two investigational medicinal products (IMPs), IBA and IBU, on the time to onset of pain relief (when the patient begins to feel any pain relieving effect from the drug) in the first 60 minutes after study medication intake. The effect of IBA or IBU will be assessed, for this first 60 minute observation period, in absence of intake of any rescue medication, using a stopwatch clock.
    Valutare l’efficacia clinica dei due prodotti sperimentali (IMPs), IBA e IBU, sul tempo di insorgenza del sollievo dal dolore (quando il paziente comincia a sentire sollievo dal dolore per effetto del farmaco) nei primi 60 minuti dopo l’assunzione del farmaco. L’effetto di IBA o IBU verrà valutato, per i primi 60 minuti del periodo di osservazione, in assenza di qualsiasi altro farmaco di salvataggio (rescue medication), utilizzando un cronografo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    60 minutes after study medication intake.
    60 minuti dall'assunzione del medicinale.
    E.5.2Secondary end point(s)
    •The evaluation of Total Pain relief (TOTPAR) by the measurement of the area under the curve (AUC) of pain intensity values, assessed by the patients, using a Visual Analogue Scale (VAS) during the first 60 minutes after study medication intake; •The proportion of patients with at least 50% pain relief; •The pain relief (PR) effect, at each observation point, using a Pain Relief Rating (PRR) score of five points; •The time to achievement the “meaningful pain relief” (when the patient feels his pain relief is meaningful to him) using a stopwatch clock; •The time to the first intake of rescue medication; •The rate of remedication (proportion of patients who require rescue medication); •The Clinical Global Impression (CGI) of the patient at the end of the study (360th minute), using a 7 point scale; •The Pain Intensity Difference at each observation point (PID) (the pain intensity differences from baseline); •The Sum of Pain Intensity Difference (SPID). •Frequency of Adverse Events in the two treatment groups
    •La valutazione del Sollievo Totale dal Dolore (TOTPAR) mediante la misurazione dell’area sotto la curva (AUC) dei valori dell’intensità del dolore, valutati dai pazienti, utilizzando una Scala Analogica Visiva (VAS) durante i primi 60 minuti dopo l’assunzione del farmaco dello studio; •La proporzione dei pazienti che presentano almeno il 50% di sollievo dal dolore; •L’effetto sul sollievo dal dolore (PR), ad ogni punto di osservazione, utilizzando una Scala di Sollievo dal Dolore (PRR) a 5 punti; •Il tempo di raggiungimento di un “sollievo significativo dal dolore” (quando il paziente sente che il sollievo dal dolore è significativo per lui/lei) utilizzando un cronografo; •Il tempo di ricorso alla prima assunzione di farmaco di salvataggio; •Il tasso di ricorso a farmaco di salvataggio (proporzione di pazienti che ricorrono al farmaco di salvataggio); •La Valutazione Clinica Globale (CGI) del paziente al termine dello studio, (360mo minuto) utilizzando una scala a 7 punti; •La Differenza di Intensità del Dolore ad ogni punto di osservazione (PID) (le differenze di intensità del dolore rispetto al basale); •La somma della differenza di intensità del dolore (SPID); •Frequenza di Eventi Avversi nei due gruppi di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 minutes after study medication intake.
    60 minuti dall'assunzione del medicinale.
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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 concerned8
    E.8.5The trial involves multiple Member States No
    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 No
    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 months7
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state158
    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 end of the study the subjects will be treated according to the standard clinical practice.
    Al termine dello studio i soggetti saranno trattati secondo la pratica clinica standard.
    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 Decision2012-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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