Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43839   clinical trials with a EudraCT protocol, of which   7280   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-022060-13
    Sponsor's Protocol Code Number:MC/PR/9900/004/10
    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:2011-11-28
    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 number2010-022060-13
    A.3Full title of the trial
    MULTICENTRE, RANDOMIZED, OPEN-LABEL, TWO-ARM PARALLEL GROUPS, ACTIVE CONTROLLED STUDY DESIGN TO DEMONSTRATE EFFICACY AND TOLERABILITY OF CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK VS CLODRONATE 100 MG/3,3ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK IN A 1-YEAR TREATMENT PERIOD OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS
    STUDIO MULTICENTRICO, RANDOMIZZATO, IN APERTO, A DUE GRUPPI PARALLELI DI TRATTAMENTO PER DIMOSTRARE L'EFFICACIA E LA TOLLERABILITA'™ DI UNA SOLUZIONE DI CLODRONATO 200MG/4 ML PER USO INTRAMUSCOLARE CON 1% LIDOCAINA SOMMINISTRATA UNA VOLTA OGNI DUE SETTIMANE RISPETTO AD UNA SOLUZIONE DI CLODRONATO 100MG/3,3 ML PER USO INTRAMUSCOLARE CON 1% LIDOCAINA SOMMINISTRATA UNA VOLTA A SETTIMANA, PER UN PERIODO DI TRATTAMENTO DI UN ANNO, IN DONNE CON OSTEOPOROSI POST-MENOPAUSALE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    MULTICENTER STUDY WITH RANDOM DISTRIBUTION OF TWO TREATMENTS USED IN PARALLEL TO DEMOSTRATE THE EFFICACY AND SAEFTY OF A SOLUTION OF CLODRONATE 200mg / 4 ml ADMINISTRED INTRAMUSCULARLY ONCE EVERY TWO WEEKS WITH 1% LIDOCAINE VS CLODRONATE 100 MG/3,3ML ADMINISTRED INTRAMUSCOLARY ONCE A WEEK WITH 1% LIDOCAINE IN OF WOMEN WITH POSTMENOPAUSAL OSTEOPOROSIS
    STUDIO MULTICENTRICO, A DISTRIBUZIONE CASUALE DEI DUE TRATTAMENTI UTILIZZATI IN PARALLELO PER DIMOSTRARE L’EFFICACIA E LA TOLLERABILITA’ DI UNA SOLUZIONE DI CLODRONATO 200MG/4 ML SOMMINISTRATA PER VIA INTRAMUSCOLARE UNA VOLTA OGNI DUE SETTIMANE CON 1% LIDOCAINA RISPETTO AD UNA SOLUZIONE DI CLODRONATO 100MG/3,3 ML SOMMINISTRATA PER VIA INTRAMUSCOLARE UNA VOLTA A SETTIMANA CON 1% LIDOCAINA IN DONNE CON OSTEOPOROSI POST-MENOPAUSALE
    A.4.1Sponsor's protocol code numberMC/PR/9900/004/10
    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 SponsorCHIESI
    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 supportCHIESI FARMACUITICI S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROMSOURCE srl
    B.5.2Functional name of contact pointClinical Research Unit 1
    B.5.3 Address:
    B.5.3.1Street AddressVia Scuderlando 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37135
    B.5.3.4CountryItaly
    B.5.4Telephone number045 8222811
    B.5.5Fax number045 8222812
    B.5.6E-mailjenny.zecchini@cromgroup.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 nameDISODIUM CLODRONATE 200mg/4 ml WITH 1% LIDOCAINE
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClodronic acid disodium
    D.3.9.1CAS number 88416-50-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine hydrochloride
    D.3.9.1CAS number 6108-05-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 CLODY*IM 6F 100MG+33MG C/LID
    D.2.1.1.2Name of the Marketing Authorisation holderPROMEDICA 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClodronic acid disodium
    D.3.9.1CAS number 88416-50-6
    D.3.9.3Other descriptive nameCLODY
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLidocaine hydrochloride
    D.3.9.1CAS number 6108-05-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33
    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
    Postmenopausal osteoporosis
    Osteoporosi post-menopausale
    E.1.1.1Medical condition in easily understood language
    Decrease in mass and changes in bone microarchitecture in postmenopausal women
    Diminuzione di massa e modificazioni della microarchitettura delle ossa in donne in menopausa
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10031285
    E.1.2Term Osteoporosis postmenopausal
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that disodium clodronate 200 mg/4 ml solution for i.m. use with 1% lidocaine administered every other week is not-inferior to disodium clodronate 100 mg/3,3 ml for i.m. use with 1% lidocaine administered once-week in terms of lumbar Bone Mineral Density (BMD).
    Dimostrare che la soluzione di Disodio Clodronato 200mg/4ml per uso i.m. con l’1% di Lidocaina somministrata 1 volta ogni due settimane non è inferiore al Disodio Clodronato 100mg/3,3ml per uso i.m., con l’1% di Lidocaina somministrato 1 volta a settimana in termini di Densità Minerale Ossea (BMD) lombare
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study will be:  To assess the efficacy of the two investigational study drugs on femoral-neck BMD, serum level of turnover bone biomarkers (CTX and BALP) and treatment compliance.  To assess the safety of the two investigational study drugs as regards local pain and tolerability assessment, frequency of adverse events, laboratory parameters and vital signs (heart rate and blood pressure).
    gli obbiettivi secondari dello studio saranno: • Valutare l’efficacia dei due farmaci in studio sulla BMD del collo del femore, livelli del siero dei biomarcatori del ricambio osseo (CTX e BALP) e l’adesione al trattamento • Valutare la sicurezza dei due farmaci in studio e in merito alla valutazione del dolore locale e della tollerabilità, alla frequenza degli eventi avversi, ai parametri di laboratorio e ai segni vitali (battito cardiaco e pressione sanguigna).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject’s written informed consent obtained prior to any study-related procedures; 2. Postmenopausal (any menses in the last 5 years) female subjects > 50 years old with lumbar-neck T-score < -2,5 and > -4 or femoral neck T-score <-2,5 and >-3; 3. At least three intact vertebrae between L1 and L4 and two evaluable vertebrae for DXA; 4. Patients treated according to the non-pharmacological standard of care; 5. Patients with the possibility and willingness to take the i.m. injections.
    1. Un consenso informato firmato dal paziente deve esser raccolto prima di iniziare le procedure legate allo studio 2. Donne in stato postmenopausale (nessuna mestruazione negli ultimi 5 anni) con età &gt; 50 anni con un T-score del collo lombare compreso tra -4 e -2,5 o del collo femorale compreso tra -3 e -2,5 3. Almeno tre vertebre intatte tra L1 e L4 e due vertebre valutabili per la DXA 4. Pazienti trattate secondo lo standard non-farmacologico di cura 5. Pazienti con la possibilità e la volontà di effettuare le iniezioni i.m.
    E.4Principal exclusion criteria
    1. BMI < 19 kg/m2; 2. History of: ever use of intravenous bisphosphonates or strontium ranelate, more than 12 months of bisphosphonates (oral and intramuscular) continuatively , or any use of bisphosphonates (oral and intramuscular) within the last year, rhPTH use (recombinant human PTH) in the last 2 years, calcitonin use within the past 3 months, raloxifene and tamoxifen in the last 6 months or for more than 12 months in the last 2 years, fluoride (> 1 mg/die) for at least a month within the past 5 years; 3. Use of estrogen (oral or patch) for more than 1 month in the last 6 months or more than 12 months in the last 2 years; 4. Serious diseases of the oral cavity and surgery and/or dental implant from less than a month or planned in the next 12 months; 5. Type 1 or uncontrolled type 2 diabetes mellitus (defined as hemoglobin A1C >10,0), or currently using insulin; 6. Family history of malignant hyperthermia; 7. Heart disease, particularly bradyarrhythmias and heart failure; Adams-Stokes syndrome, Wolff-Parkinson-White syndrome or severe degrees of sinoatrial, atrioventricular or intraventricular block, acute cardiac decompensation; 8. History of kidney failure or renal insufficiency (creatinine > 2,0 mg/dl) 9. History of stroke in the last 6 months or uncontrolled hypertension; 10. History of hypercalciuria; 11. History of hypercalcemia, sarcoidosis, hyperparathyroidism, hyperthyroidism or hypothyroidism (except for patients in conditions of euthyroidism taking stable dose of thyroid hormone from at least 6 weeks); 12. History of any malignancy except for epithelioma considered cured; 13. Patients currently treated with systemic corticosteroids or > 2000 mcg beclomethasone dipropionate or equivalent daily; 14. Patients currently treated with antiepileptic drugs and/or anticoagulants or treated in the last 6 months or for more than 12 months in the last 2 years; 15. Patients current treated with propanolol, cimetidine or digitalis drugs; 16. History of alcohol or drug abuse; 17. Allergy, sensitivity or intolerance to study drugs (included lidocaine or other amide-type local anaesthetics) or excipients; 18. Subjects unlikely to comply with the study protocol or unable to understand the nature and scope of the study but also the possible benefits or unwanted effects of the study treatments. 19. Subjects who received any investigational new drug, or participated in clinical study within the last 12 weeks. 20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 21. Femoral-neck T-score <-3
    1. BMI &lt; 19 kg/m2; 2. Storia di: utilizzo dei bifosfonati per via endovenosa o ranelato di stronzio, utilizzo per più di 12 mesi dei bisfosfonati (orali e intramuscolari) continuativamente, o qualsiasi uso di bifosfonati (orale e intramuscolare) entro l 'anno precedente, uso di rhPTH (PTH umano ricombinante) negli ultimi 2 anni, uso della calcitonina negli ultimi 3 mesi, raloxifene e tamoxifene negli ultimi 6 mesi o per più di 12 mesi negli ultimi 2 anni, uso di fluoro (&gt; 1 mg / die) per almeno un mese negli ultimi 5 anni; 3. L'uso di estrogeni (per via orale o patch) per più di 1 mese negli ultimi 6 mesi o più di 12 mesi negli ultimi 2 anni; 4. Gravi malattie del cavo orale e chirurgia e / o impianto dentale da meno di un mese o previsto nei prossimi 12 mesi; 5. Diabete mellito di Tipo 1 o Tipo 2 incontrollato (definita come l'emoglobina A1C&gt; 10,0), o attuale uso di insulina; 6. Storia familiare di ipertermia maligna 7. Malattie cardiache, in particolare bradi aritmie e insufficienza cardiaca, sindrome di Adams-Stokes, sindrome di Wolff-Parkinson-White o gradi severi di blocco seno-atriale, atrioventricolare o intraventricolare, scompenso cardiaco acuto; 8. Storia di insufficienza renale o insufficienza renale (creatinina&gt; 2,0 mg / dl) 9. Storia di ictus negli ultimi 6 mesi o ipertensione non controllata; 10. Storia di ipercalcinuria 11. Storia di ipercalcemia, sarcoidosi, iperparatiroidismo, ipertiroidismo o ipotiroidismo (tranne per i pazienti in condizioni di eutiroidismo che prendono un dosaggio stabile di ormone tiroideo da almeno 6 settimane); 12. Storia di una neoplasia maligna ad eccezione di epitelioma considerato guarito 13. I pazienti in trattamento con corticosteroidi sistemici o beclometasone dipropionato &gt; 2000 mcg al giorno o equivalente 14. Pazienti in trattamento con farmaci antiepilettici e / o anticoagulanti o trattati negli ultimi 6 mesi o per più di 12 mesi negli ultimi 2 anni; 15. Pazienti in corso di trattamento con propanololo, cimetidina o farmaci digitalici; 16. Storia di abuso di alcool o di droghe; 17. Allergia, sensibilità o intolleranza ai farmaci in esame (incluso lidocaina o altri anestetici di tipo amidico locale) o eccipienti; 18. Soggetti non in grado di rispettare il protocollo di studio o incapaci di comprendere la natura e la portata dello studio, ma anche i possibili benefici o effetti indesiderati dei trattamenti in studio. 19. Soggetti che hanno ricevuto qualche farmaco sperimentale nuovo, o partecipato a studi clinici nelle ultime 12 settimane. 20. Altra grave condizione acuta o cronica medica o psichiatrica o anomalie di laboratorio che possono aumentare il rischio connesso alla partecipazione allo studio o alla somministrazione del farmaco di studio o che possa interferire con l'interpretazione dei risultati dello studio e, a giudizio del medico dello studio, ciò che renderebbe il soggetto inadeguato per l'ingresso in questo studio. 21. T-score del collo femorale &lt;-3
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the value of lumbar BMD after 1-year treatment. DXA scan will be evaluated by a centralised laboratory.
    La variabile primaria di efficacia è il valore della BMD lombare dopo un anno di trattamento. La scansione DXA sarà effettuata da un laboratorio centralizzato
    E.5.1.1Timepoint(s) of evaluation of this end point
    One yers (48 weeks) of treatment
    Un anno (48 settimane)di trattamento
    E.5.2Secondary end point(s)
     Lumbar BMD after 24-week treatment (carried out in a centralised laboratory);  Femoral-neck BMD after 24-week and 1-year treatment (carried out in a centralised laboratory);  Biochemical markers of bone turnover after 24 and 48 weeks of treatment (carried out in a centralised laboratory);  Compliance evaluated at each visit after randomization visit.
    • La BMD lombare dopo 24 settimane di trattamento (analisi effettuata dal laboratorio centralizzato) • La BMD del collo femorale dopo 24 settimane di trattamento (analisi effettuata dal laboratorio centralizzato) • I marcatori biochimici del ricambio osseo dopo 24 e 48 settimane di trattamento (analisi effettuata dal laboratorio centralizzato) • Adesione al trattamento valutata ad ogni visita dopo la randomizzazione.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 24 and 48 weeks. Every 12 weeks after the first 12 weeks with regard to adherence to treatment
    A 24 e a 48 settimane. Ogni 12 settimane dopo le prime 12 settimane per quanto riguarda l'aderenza al 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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tollerabilità
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    disodio clodronato100mg/3,3ml con 1% di lidocaina - Stesso farmaco ad altro dosaggio
    Disodium clodronate 100mg/3,3ml with 1% lidocaine - same IMP used at different dosage
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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 months20
    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 months20
    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.1.1Number 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: 110
    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 No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Post-manopausal women
    Donne in post-manopausa
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    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)
    Not aplicable
    Non applicabile
    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 Decision2011-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-31
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Tue Apr 16 07:24:43 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA