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    Summary
    EudraCT Number:2011-002000-32
    Sponsor's Protocol Code Number:CTBM100C2401
    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:2012-03-06
    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 number2011-002000-32
    A.3Full title of the trial
    A single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
    Studio a singolo braccio, in aperto, multicentrico, di fase IV per valutare la sicurezza a lungo termine della tobramicina in polvere per inalazione (TIP) in pazienti affetti da Fibrosi Cistica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis
    Uno studio clinico per studiare la sicurezza a lungo termine della tobramicina in polvere (TIP)per inalazione in pazienti con fibrosi cistica.
    A.4.1Sponsor's protocol code numberCTBM100C2401
    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 SponsorNOVARTIS FARMA
    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 supportNovartis
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Farma
    B.5.2Functional name of contact pointDrug Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressLargo Umberto Boccioni, 1
    B.5.3.2Town/ cityOriggio
    B.5.3.3Post code21040
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 96541
    B.5.5Fax number+39 02 9659066
    B.5.6E-mailinfo.studiclinici@novartis.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/140
    D.3 Description of the IMP
    D.3.1Product nameTobramycin inhalation powder
    D.3.2Product code TBM100C
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOBRAMYCIN
    D.3.9.1CAS number 32986-56-4
    D.3.9.2Current sponsor codeTBM100C
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number28
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pseudomonas aeruginosa infection in cystic fibrosis patients
    pazienti affetti da Fibrosi Cistica con infezione polmonare cronica da P. Aeruginosa
    E.1.1.1Medical condition in easily understood language
    Bacterial infection in cystic fibrosis patients
    Infezione batterica nei pazienti con fibrosi cistica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10021860
    E.1.2Term Infection pseudomonas aeruginosa
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety of TIP over 6 cycles of treatment in terms of the incidence of treatment emergent adverse events (AEs).
    Valutare il profilo di sicurezza di TIP durante i 6 cicli di trattamento in termini di incidenza di eventi avversi (EA) emergenti nel periodo di trattamento.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety profile of TIP in terms of acute change in FEV1 - To assess the efficacy of TIP over 6 cycles of treatment, as measured by the relative change in FEV1 , FVC and FEF25-75 - To assess the efficacy of TIP over 6 cycles of treatment, as measured by the absolute change in P. aeruginosa CFU in sputum. - To evaluate the safety of TIP for P. aeruginosa tobramycin MIC as judged by change from baseline to the end of the dosing periods - To evaluate the safety profile of TIP in terms of clinical laboratory results and, (in a subset of patients) audiology throughout the treatment period. - To assess time to first and the rate of hospitalization due to serious respiratory-related AEs - PLS SEE PROTOCOL
     Valutare il profilo di sicurezza di TIP in termini di variazione della percentuale prevista del volume espiratorio forzato in 1 secondo (FEV1) dalla valutazione pre-dose a quella effettuata 30 minuti dopo la somministrazione del farmaco ad ogni visita al centro. (Visite 2, 3, 5, 7, 9, 11 e 13)  Valutare l'efficacia di TIP durante i 6 cicli di trattamento in termini di variazione relativa del FEV1 (FEV1% del predetto), FVC (FVC% del predetto) e FEF25-75 (FEF25-75% del predetto) dal basale fino al termine di ogni ciclo di somministrazione del farmaco (Visite 3, 5, 7, 9, 11 e 13) e alla fine dell’ultimo periodo-off di trattamento (Visita 14)  PER FAVORE VEDERE SINOSSI IN ITALIANO
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provide written informed consent, HIPAA (Health Insurance Portability and Accountability Act) authorization (where applicable), and XML File Identifier: UGnn5J20LNZMVSsjPK63GC70b1Y= Page 11/24 assent (as appropriate) prior to the performance of any study-related procedure. 2. Confirmed diagnosis of CF by one or more of the following tests for CF (current or historic): • quantitative pilocarpine iontophoresis sweat chloride test of > 60 mmol/L, • genotype with two identifiable CF-causing mutations, • a positive newborn screening for CF, • an abnormal nasal transepithelial potential difference characteristic of CF 3. Male and female patients ≥ 6 years of age at screening (Visit 1). 4. FEV1 at screening (Visit 1) must be ≥ 25% and ≤75% of normal predicted values for age, sex, and height based on the Knudson equation. 5. P aeruginosa must be present in a sputum/deep cough throat swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deepthroat cough swab culture at screening (Visit 1). 6. Able to comply with all protocol requirements. 7. Clinically stable in the opinion of the investigator.
    1. Consenso informato scritto 2. Diagnosi di fibrosi cistica accertata da una o più caratteristiche cliniche:  test del sudore documentato con valori &gt; 60 mEq/L tramite ionoforesi quantitativa con pilocarpina  genotipo con 2 mutazioni identificabili che causano la fibrosi cistica  screening neonatale positivo per la fibrosi cistica 3. Soggetti di entrambi i sessi di età ≥ ai 6 anni al momento dello screening 4. Il FEV1 al momento dello screening (Visita 1) deve essere ≥ 25% e ≤75% del valore predetto per età, sesso e altezza in base all'equazione Knudson 5. Isolamento di P. Aeruginosa tramite coltura dell’espettorato/tampone orofaringeo (o lavaggio broncoalveolare, BAL) nei 6 mesi precedenti lo screening e al momento della visita di screening (visit 1). 6. Soggetti in grado di soddisfare tutti i requisiti del protocollo 7. Soggetti clinicamente stabili a giudizio del medico responsabile dello studio
    E.4Principal exclusion criteria
    1. History of sputum culture or deep cough throat swab (or BAL) culture yielding Burkholderia cenocepacia (B cc) complex within 2 years prior to screening and/or sputum culture yielding B cc. complex at screening (Visit 1). 2. Hemoptysis more than 60 mL at any time within 30 days prior to study drug administration (Visit 2). 3. History of hearing loss or chronic tinnitus deemed clinically significant by the investigator. 4. Serum creatinine 2 mg/dl or more, BUN 40 mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening (Visit 1). 5. Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics. 6. Patients who are regularly receiving more than 1 class of inhaled antipseudomonal antibiotic (inhaled anti-pseudomonal antibiotic are not allowed other than the study drug). 7. Any use of inhaled anti-pseudomonal antibiotics within 28 days prior to study drug administration (Visit 2). 8. Use of systemic anti-pseudomonal antibiotics within 28 days prior to study drug administration (Visit 2). 9. Use of loop diuretics within 7 days prior to study drug administration (Visit 2). 10. Administration of any investigational drug within 30 days prior to enrollment (Visit 1) or 5 halflives, whichever is longer. 11. Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax. 12. History of malignancy of any organ system, treated or untreated, regardless of whether there is evidence of local recurrence or metastases. 13. Patients with clinically significant laboratory abnormalities (not associated with the study indication) at screening (Visit 1). 14. Patients with other clinically significant conditions (not associated with the study indication) at screening (Visit 1) which might interfere with the assessment of this study. 15. Patients or caregivers with a history of noncompliance to medical regimens and patients or caregivers who are considered potentially unreliable. 16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL) at screening (Visit 1). 17. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method. PLS SEE PROTOCOL
    1 Storia di coltura dell’espettorato, tampone orofaringeo o coltura di un campione delle basse vie respiratorie, positivo per Burkholderia Cepacia (B. Cepacia) nei due anni che precedono lo screening e/o coltura dell’espettorato positivo per B. Cepacia al momento dello screening 2 Emottisi, clinicamente significativa in base all'età e allo stato clinico dei soggetti nei 30 giorni precedenti la somministrazione del farmaco di studio (visita 2) 3 Storia personale/familiare di capacità uditiva anormale o tinnito cronico considerato clinicamente significativo dallo sperimentatore. 4 Creatinina sierica uguale o al di sopra di 2 mg/dL, BUN uguale o al di sopra di 40 mg/dL o un esame delle urine con valori anomali definiti come +2 o una proteinuria più elevata al momento dello screening 5 Nota ipersensibilità locale o sistemica agli aminoglicosidi o antibiotici per via inalatoria 6 Pazienti che sono regolarmente in terapia con più di una classe di antibiotici antipseudomonas per via inalatoria (non sono ammessi altri antibiotici antipseudomonas per via inalatoria diversi dal farmaco in studio). 7 Somministrazione di qualsiasi antibiotico antipseudomonas per via inalatoria nei 28 giorni precedenti la somministrazione del farmaco in studio (visita 2) 8 Somministrazione di qualsiasi antibiotico antipseudomonas per via sistemica nei 28 giorni precedenti la somministrazione del farmaco in studio (visita 2) 9 Somministrazione di diuretici dell’ansa nei 7 giorni precedenti la somministrazione del farmaco in studio (visita 2) Somministrazione di qualsiasi farmaco sperimentale entro 30 giorni o 5 emivite prima dell’arruolamento, qualunque sia la durata 10 Somministrazione di qualsiasi farmaco sperimentale entro 30 giorni o 5 emivite prima dell’arruolamento, qualunque sia la durata 11 Segni e sintomi di malattia polmonare acuta, i.e., polmonite, pneumotorace 12 Storia di neoplasie maligne per qualsiasi sistema d’organo, trattate o non trattate, indipendentemente dal fatto che non vi è prova della recidiva locale o di metastasi 13 Pazienti con anomalie di laboratorio clinicamente significative (non associate con l'indicazione di studio) al momento dello screening (visita 1) 14 Pazienti con altre condizioni clinicamente significative, comprese malattie congenite diverse dalla fibrosi cistica (non associate con l'indicazione di studio) al momento dello screening che potrebbero interferire con le valutazioni di questo studio 15 Soggetti o badanti con una storia di non conformità a regimi medici e pazienti o badanti che sono considerati potenzialmente inaffidabili 16 Donne in gravidanza o in allattamento, in cui lo stato di gravidanza di una donna è definito come il periodo che va dal concepimento fino al termine della gestazione, confermato da un test positivo di laboratorio hCG (&gt; 5 mUI / ml) al momento dello screening (Visita 1) 17 Donne in età potenzialmente fertile, definite come tutte le donne fisiologicamente in grado di concepire, comprese le donne il cui stile di vita, o l'orientamento sessuale impedisce un rapporto sessuale con un partner maschile e le donne i cui partner sono stati sterilizzati tramite vasectomia o altre procedure, a meno che non utilizzino due metodi di controllo delle nascite. I due metodi possono essere un doppio metodo a barriera o un metodo a barriera più un metodo ormonale.  Metodi di contraccezione a barriera includono: diaframma, preservativo (per il partner), il dispositivo intrauterino (di rame o ormonali), spugna vaginale o spermicida. Contraccettivi ormonali includono qualsiasi agente contraccettivo in commercio che include un estrogeno e/o un agente progestinico  PER FAVORE VEDERE SINOSSI IN ITALIANO
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of treatment emergent adverse event
    L'incidenza dell'evento avverso emergente al trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 6 cycles of treatment period
    oltre 6 cicli del periodo di trattamento
    E.5.2Secondary end point(s)
    1) Relative change in FEV1 % predicted, FVC % predicted and FEF25-75 % predicted from baseline 2) Relative change in P aeruginosa CFU in sputum from baseline 3) Change in P aeruginosa tobramycin MIC from baseline 4) Rate of and time to the first hospitalization due to serious respiratoryrelated AE 5) Rate of and time to the first use of anti-pseudomonal antibiotics (overall, oral, intravenous) 6) Acute change in FEV% predicted from pre-dose to post-dose 30 minutes 7) Evaluation of clinical laboratory results and audiology(in a sub-set of patients)
    1) Il cambiamento relativo in FEV1 % predicted, FVC % predicted e FEF25- 75% predicted dal basale. 2) Cambiamento relativo in aeruginosa P CFU nell'espettorato dal basale. 3) Cambiamento nella aeruginosa P tobramicina MIC dal basale. 4) Tasso di tempo alla prima ospedalizzazione per Evento Avverso Grave respiratorio 5) Tasso di e tempo al primo uso degli antibiotici anti-pseudomona (sistemico, orale, endovenoso) 6)Cambiamenti acuti in FEV% predetto dalla pre-dose alla post-dose 30 minuti 7) Valutazione dei risultati clinici di laboratorio e audiologia (in a sub-set di pazienti)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) (Visit 2) => At Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14. 2) (Visit 2) => At Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14. 3) (Visit 2) => At Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14 4) over 6 cycles of treatment period 5) over 6 cycles of treatment period 6) At Visit 2, Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13. 7) Evaluation of clinical laboratory results and (in a sub-set of patients) audiology: over 6 cycles of treatment period
    1) (Visit 2) => A Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14. 2) (Visit 2) => A Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14. 3) (Visit 2) => A Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13, Visit 14 4) dopo 6 cicli del periodo di trattamento 5) dopo 6 cicli del periodo di trattamento 6) A Visit 2, Visit 3, Visit 5, Visit 7, Visit 9, Visit 11, Visit 13. 7) Valutazione dei risultati clinici di laboratorio e (in un sub-set di pazienti)audiologia: dopo 6 cicli del periodo di trattamento.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    Mexico
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV : 14/OCT/2013
    LPLV : 14/10/2013
    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 months24
    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 months24
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children
    Bambini
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 150
    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)
    standard
    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 Decision2012-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-07
    P. End of Trial
    P.End of Trial StatusCompleted
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