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    Summary
    EudraCT Number:2010-019598-13
    Sponsor's Protocol Code Number:MOLT-2009-01
    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:2011-12-27
    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 number2010-019598-13
    A.3Full title of the trial
    A randomised, double-blind, dose-response, placebo-controlled, multicenter, phase IIA clinical study to evaluate the efficacy and safety of topical application of G.68.y/EtOH in patients with type 1 or type 2 diabetes with infected foot ulcers.
    Studio clinico di fase IIa, randomizzato, in doppio cieco, dose-risposta, controllato verso placebo, multicentrico per valutare l'efficacia e la sicurezza di una applicazione topica di G.68.y/EtOH nel trattamento di ulcere infette del piede in pazienti affetti da diabete di tipo 1 o 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Anna
    Anna
    A.3.2Name or abbreviated title of the trial where available
    D.A.N.T.E
    D.A.N.T.E
    A.4.1Sponsor's protocol code numberMOLT-2009-01
    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 SponsorMOLTENI
    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 supportMolteni
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMolteni
    B.5.2Functional name of contact pointMolteni
    B.5.3 Address:
    B.5.3.1Street AddressS.S. 67 LOC. GRANATIERI
    B.5.3.2Town/ cityScandicci
    B.5.3.3Post code50018
    B.5.3.4CountryItaly
    B.5.4Telephone number055-7361298
    B.5.5Fax number055-7361272
    B.5.6E-mailI.CORTI@MOLTENIFARMA.IT
    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 nameG.68.y/EtOH
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther chemotherapeutics
    D.3.9.2Current sponsor codeRLP068 chloride (RLP068Cl)
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.1
    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 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 nameG.68.y/EtOH
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther chemotherapeutics
    D.3.9.2Current sponsor codeRLP068 chloride (RLP068Cl)
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.3
    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 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 nameG.68.y/EtOH
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOther chemotherapeutics
    D.3.9.2Current sponsor codeRLP068 chloride (RLP068Cl)
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.5
    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 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 AUGMENTIN*12CPR RIV 875MG+125M
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXOSMITHKLINE SpA
    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 Tablet
    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.3.8INN - Proposed INNAmoxicillin and enzyme inhibitor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number875
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboGel
    D.8.4Route of administration of the placeboCutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    patients with type 1 or type 2 diabetes with infected foot ulcers
    Soggetti affetti da diabete di tipo 1 o 2 che presentano ulcere infette del piede di grado 2
    E.1.1.1Medical condition in easily understood language
    patients with type 1 or type 2 diabetes with infected foot ulcers
    Soggetti affetti da diabete di tipo 1 o 2 che presentano ulcere infette del piede di grado 2
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021784
    E.1.2Term Infected skin ulcer
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a single, topical dose of G.68.γ/EtOH (0.1%, 0.3%, 0.5%) compared to placebo immediately after photoactivation with red light in patients with type 1 or type 2 diabetes with infected grade 2 foot ulcers, as measured by reduction in ulcer bacterial load.
    Valutare verso placebo l’efficacia di una singola applicazione topica di G.68.y/EtOH (0.1%, 0.3%, 0.5% peso/peso), subito dopo fotoilluminazione con luce rossa e tramite misura della riduzione della carica batterica, in pazienti con diabete di tipo 1 e 2 e con ulcere infette del piede di grado 2.
    E.2.2Secondary objectives of the trial
    To evaluate at Day 3, Day 8 and Day 15, the maintenance of efficacy, and the safety and tolerability of a single, topical dose of G.68.y/EtOH (0.1%, 0.3%, 0.5% w/w) after photoactivation with red light compared to placebo, in patients with type 1 or type 2 diabetes with infected grade 2 foot ulcers.
    Valutare al Giorno 3, 8 e 15 il mantenimanto dell’efficacia e la sicurezza e tollerabilita` verso placebo di una singola applicazione topica di G.68.y/EtOH (0.1%, 0.3%, 0.5% peso/peso) dopo fotoattivazione con luce rossa in pazienti con diabete di tipo 1 e 2 con ulcere infette del piede di grado 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Males or females of any race, aged 18 years or over. Females of childbearing potential must have a negative urine pregnancy test prior to commencing the study. 2. Diagnosis of type 1 or 2 diabetes. 3. A diabetic foot wound grade I or II and staging B or D, according to the TEXAS diabetic wound classification system. 4. Presence of infected foot ulcer of grade 2 (according to the PEDIS diabetic foot ulcer classification system), diagnosed via a clinic examination. 5. Presence of ulcer with an area from 2 to 15 cm2 and with a maximum diameter/length ≤ 4.6 cm measured by the VISITRAK™ system. 6. No concurrent illness indicating a life expectancy of less than 3 months. 7. Able to take oral medications. 8. Patients must provide their written informed consent to participate in the study. 9. Patients must be willing and able to comply with the protocol and study procedures. 10. Non-childbearing potential and childbearing potential female patients who agree to use an acceptable method of contraception for 60 days after the Treatment Visit (i.e., 60 days from the first and only application of the study drug) providing they are not pregnant or lactating. 11. Male patients must agree to use adequate methods of contraception for 30 days from the time of the Treatment Visit (i.e. 30 days from the first and only application of the study drug).
    1. Maschi o femmine di qualsiasi razza, di almeno 18 anni. Le donne in eta` fertile devono avere un test di gravidanza negativo eseguito sulle urine prima di iniziare lo studio. 2. Diagnosi di diabete di tipo 1 o 2 3. Ulcera diabetica del piede di grado I o II e di tipo B o D, come da sistema di classificazione TEXAS per le ulcere del piede diabetico 4. Presenza di ulcera infetta del piedi di grado 2 (in accordo con il sisitema di classificazione PEDIS delle ulcere del piede diabetico) diagosticata tramite esame clinico. 5. Presenza di un’ulcera con dimensioni comprese fra 2 e 15 cm2 e con lunghezza del diametro maggiore ≤ 4.6 cm in base alla misurazione effettuata con sistema VisitrakTM. 6. Nessuna malattia concomitante che possa far presumere un’aspettativa di vita inferiore ai 3 mesi. 7. Capacita` di assumere farmaci oralmente. 8. I pazienti devono fornire il loro consenso scritto alla partecipazione allo studio 9. I pazienti devono acettare ed essere in grado di aderire al protocollo ed alle procedure dello studio 10. Donne non piu` in eta` fertile e donne in eta` fertile purche` accettino di adottare un metodo appropriato di contraccezione nei 60 giorni seguenti la Visita di Trattamento (ovvero 60 giorni dalla prima ed unica applicazione del farmaco in studio), purche` non siano gia` gravide, ne` in allattamento. 11. I pazienti di sesso maschile devono accettare di utilizzare un metodo adeguato di contraccezione per 30 giorni a partire dalla Visita di Trattamento (ovvero 30 giorni dalla prima ed unica applicazione del farmaco in studio).
    E.4Principal exclusion criteria
    1. Female patients who are pregnant or breast-feeding. 2. Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to study treatment (Visit 0 or Visit 1). 3. Patients that cannot take Augmentin at the dosage stated in the protocol and according to the current Summary of Product Characteristics (SPC). 4. Ankle brachial systolic blood pressure index (Winsor Index) < 0.5 in the infected limb. 5. Clinical diagnosis of peripheral vascular disease (PVD) with ischemic ulcer, requiring percutaneous or surgery revascularization. 6. Ulcer probe to bone positive. 7. Prior anamnestic diagnosis of methicillin-resistant Staphylococcus aureus (MSRA) infection. 8. Any surgery planned in the study period, including scheduled amputation at the infected site. 9. Use of any other photodynamic therapy agents (e.g. Foscan and Photofrin) in the 5 days before study treatment (Visit 0 or Visit 1). 10. Use of any antibiotics (local or systemic) in a continuative way for a period ≥ 5 days prior to Treatment Visit (Visit 1). 11. Use of cortisone or other corticosteroids (local or systemic) in the 5 days before study treatment (Visit 0 or Visit 1). 12. Diagnosis of severe medical conditions such as severe heart failure or severe hepatic disease, according to the Investigator’s judgment. 13. Existence of any surgical or medical condition which, in the judgement of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the drug product. 14. Diagnosis of current cancer. 15. History of any medical or psychiatric conditions that, according to the Investigator, may increase the risks associated with the study’s participation or investigational product(s) administration. 16. History of any clinically significant photosensitive skin disorder. 17. Anamnestic diagnosis of alcohol dependence or substance dependence. 18. Known hypersensitivity to the TegadermTM patch. 19. Diagnosis of Acanthosis nigricans.
    1. Pazienti di sesso femminile che siano gravide o in allattamento. 2. Partecipazione a qualsiasi altro studio clinico nei 30 giorni precedenti il trattamento (Visita 0 o Visita1) o attualmente in trattamento con un farmaco sperimentale. 3. Pazienti che non possono assumere Augmentin al dosaggio stabilito dal protocollo e secondo quanto riportato nel Riassunto delle Caratteristiche del Prodotto. 4. Indice della pressione sanguigna sistolica brachiale alla caviglia (indice di Winsor) &lt; 0.5 nell’arto infetto. 5. Diagnosi clinica di malattia vascolare periferica (PVD) con ulcera ischemica che richieda una rivascolarizzazione percutanea o chirurgica. 6. Ulcera positiva al test “probe to bone”. 7. Precedente diagnosi anamnestica di infezione resistente a Staphylococcus aureus (MSRA). 8. Qualsiasi intervento chirurgico gia` pianificato nel periodo dello studio, compresa l’amputazione dell’arto infetto. 9. Uso di qualsiasi altro agente per terapia fotodinamica (es. Foscan e Photofrin) nei 5 giorni precedenti il trattamento (Visita 0 o Visita 1). 10. Uso di qualsiasi antibiotico (locale o sistemico) in modo continuativo per un periodo di tempo uguale o superiore a 5 giorni antecedenti alla visita di trattamento (Visita 1). 11. Uso di cortisone o altri corticosteroidi (locali o sistemici) nei 5 giorni precedenti il trattamento (Visita 0 o Visita 1). 12. Diagnosi di una condizione medica grave come una insufficienza cardiaca grave e una grave insufficienza epatica, secondo il giudizio dello sperimentatore. 13. Esistenza di qualsiasi condizione medica o chirurgica che, a giudizio dello sperimentatore, possa interferire con l’assorbimento, la distribuizione, il metabolismo o l’escrezione del farmaco in studio. 14. Diagnosi concomitante di cancro. 15. Qualsiasi condizione medica o psichiatrica nella storia clinica del paziente che, a giudizio dello sperimentatore, possa accrescere il rischio associato alla partecipazione allo studio o alla somministrazione del farmaco in studio. 16. Riscontro nella storia clinica di un qualsiasi fenomeno significativo di fotosensibilizzazione della pelle. 17. Diagnosi anamnestica di dipendenza da alcool o abuso di sostanze. 18. Ipersensibilita` nota al cerotto TegadermTM. 19. Diagnosi di Acanthosis nigricans.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the reduction in the ulcer bacterial load between pre-treatment (baseline) and immediately after illumination on Day 1 (Visit 0 or Visit 1) as measured by an ulcer sample drawn with a flocked nylon swab.
    L’end-point primario per l’efficacia e` la riduzione della carica batterica dell’ulcera fra il pre-trattamento (valore basale) e subito dopo illuminazione al Giorno 1 (Visita 0 o Visita 1) misurato tramite campione prelevato con tampone floccato di nylon.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1: pre-treatment (baseline) and immediately after illumination
    Giorno 1: pre trattamento (valore basale) e subito dopo l`illuminazione
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.2.3.1Comparator description
    - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    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
    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.1.3Elderly (>=65 years) Yes
    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 state60
    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 Decision2010-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
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