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    Summary
    EudraCT Number:2005-002463-88
    Sponsor's Protocol Code Number:L00133IV301(ORF)
    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:2006-04-21
    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 number2005-002463-88
    A.3Full title of the trial
    Efficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM): prospective, randomised, double-blind, placebo-controlled study.
    Efficacia ed innocuita` di un`immunoglobulina umana per amministrazione endovenosa (IVIg) nel trattamento della dermatomiosite (DM) e della polimiosite (PM): studio prospettivo, randomizzato, in doppio cieco controllato verso placebo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM)
    fficacy and safety of a human normal immunoglobulin product for intravenous administration (IVIg) in the treatment of dermatomyositis (DM) and polymyositis (PM)
    A.4.1Sponsor's protocol code numberL00133IV301(ORF)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN87782942
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/165/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorORFAGEN
    B.1.3.4CountryFrance
    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 supportORFAGEN
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationORFAGEN
    B.5.2Functional name of contact pointCRDPF Langlade
    B.5.3 Address:
    B.5.3.1Street Address3 avenue Hubert Curien
    B.5.3.2Town/ cityToulouse cedex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number+33534506458
    B.5.5Fax number+33534503458
    B.5.6E-mailorfagen@orfagen.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 IGVENA*FL 200ML 10G+SET
    D.2.1.1.2Name of the Marketing Authorisation holderKEDRION 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/169 e EU/3/03/170
    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 IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit g/ml gram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number.05
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    Idiopathic dermatomyositis and polymyositis with insufficiently improved muscle strength under conventional therapy (glucocorticosteroids associated with immunosuppressors).
    Dermatomiosite e polimiosite idiopatici con un aumento della forza muscolare insufficiente sotto terapia convenzionale(glucocorticosteroidi associati a immunosuppressori).
    E.1.1.1Medical condition in easily understood language
    Dermatomyositis and polymyositis
    Dermatomiosite e polimiosite
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLT
    E.1.2Classification code 10003821
    E.1.2Term Muscular autoimmune disorders
    E.1.2System Organ Class 100000004870
    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 efficacy of the IVIg product as adjunctive treatment to conventional glucocorticosteroids (GS) and immunosuppressors (IS) in DM and PM patients with insufficient improvement of muscle strength.
    valutare l`efficacia dell`IVIg come trattamento aggiuntivo ai trattamenti convenzionali con glucocorticosteroidi (GS) ed immunosuppressori (IS) nei pazienti che soffrono di DM e di PM, che presentano un aumento della forza muscolare insufficiente.
    E.2.2Secondary objectives of the trial
    to assess the overall safety profile of the IVIg product in DM and PM patients.
    valutare il profilo globale d`innocuita` del prodotto IVIg nei pazienti che soffrono di DM e di PM.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female patients of at least 18 years of age - Patients fulfilling the diagnostic criteria (definite or probable) of the European Neuro-Muscular Committee (ENMC) for idiopathic DM and PM.- Patients with an active DM or PM disease who received conventional therapies for at least 14 weeks: prospective or clearly-documented retrospective administration of oral prednisone 1mg/Kg per day for at least 4 weeks, with or without IS, followed by IS at stable dose (methotrexate MTX 15-50 mg per week, or other IS) and prednisone for at least 10 weeks, OR Patients with a contra-indication or a major side-effect to prednisone or methotrexate / other IS,ORPatients under bitherapy (prednisone and MTX / other IS) with a documented deterioration of their BMRC score, as follows:`· Of at least 18 points if BMRC at the beginning of the run-in period over 56`· Of at least 12 points if BMRC at the beginning of the run-in period between 40.5 and 56 included`· Of at least 8 points if BMRC at the beginning of the run-in period below 40.5,ORDM patients under bitherapy (prednisone and MTX / other IS) having a documented deterioration of their cutaneous signs, as follows:`· Cutaneous signs aggravated (score from 0 or 1 to 2)`· Cutaneous signs of 2 at two consecutive visits, ORPatients under bitherapy (prednisone and MTX / other IS) with an onset of visceral involvement (e.g. pharyngeal, pulmonary, cardiac).- Patients with no significant improvement of muscle strength under conventional therapy, as follows:`· Less of 8 points if BMRC score over 56 at the beginning of the run-in period `· Less of 12 points if BMRC score between 40.5 and 56 at the beginning of the run-in period `· Less of 18 points if BMRC score below 40.5 at the beginning of the run-in period.- Patients with BMRC index between 24 and 72 at baseline.- For French centres, patients affiliated to the French Security System.- Patients able to follow instructions.- Written informed consent from the patients.
    - Uomini o donne maggiorenni.- Pazienti che soddisfano i criteri diagnostici (definiti o probabili) del Comitato Neuro-muscolare Europeo (ENMC) per i DM e PM idiopatici. - Pazienti che soffrono di DM o PM attive, che hanno ricevuto terapie convenzionali da almeno 14 settimane: somministrazione orale, prospettica o retrospettiva chiaramente documentata, di prednisone 1 mg/kg al giorno per almeno 4 settimane, con o senza IS seguito da IS a dose definita (metotrexato, MTX 15-50 mg alla settimana o altro IS) e prednisone per almeno 10 settimane, O Pazienti che presentano controindicazioni o effetti collaterali importanti al prednisone o al metatrexato / altro IS,OPazienti sotto biterapia (prednisone e MTX / altro IS) con un deterioramento documentato del punteggio BMCR, come segue:`· Di almeno 18 punti se il BMRC all`inizio del periodo di run-in e` superiore a 56`· Di almeno 12 punti se il BMRCC all`inizio del periodo di run-in e` compreso tra 40.5 e 56 inclusi`· Di almeno 8 punti se il BMRC all`inizio del periodo di run-in e` inferiore a 40.5.OPazienti affetti da DM sotto biterapia (prednisone e MTX / altro IS) che hanno un deterioramento documentato dei segni cutanei, come segue:`· Segni cutanei aggravati (punteggio da 0 o 1 a 2)`· Segni cutanei con punteggio 2 a due visite consecutive,OPazienti sotto biterapia (prednisone e MTX / altro IS) con insorgenza di interessamento viscerale (per es., faringeo, polmonare, cardiaco).- Pazienti che non hanno un aumento significativo della forza muscolare sotto terapia convenzionale, come segue:`· Meno di 8 punti se il punteggio BMRC e` superiore a 56 all`inizio del periodo di run-in`· Meno di 12 punti se il punteggio BMRC e` compreso tra 40.5 e 56 all`inizio del periodo di run-in.`· Meno di 18 punti se il punteggio BMRC e` inferiore a 40.5 all`inizio del periodo di run-in,- Pazienti con un indice BMRC compreso tra 24 e 72 rispetto ai dati di base.- Pazienti capaci di seguire le istruzioni.- Consenso informato dei pazienti per iscritto.
    E.4Principal exclusion criteria
    - Pregnant women, nursing mothers and women of childbearing potential with no reliable contraception.- Patients who do not fulfill the ENMC diagnostic criteria (definite or probable) of idiopathic DM and PM.- Patients with a diagnosis of paraneoplasic DM or PM.- Juvenile DM and PM (age less than 18 years).- DM patients with no muscle involvement.- Patients with life expectancy of less than 3 months.- Patients whose muscle strength is responsive to conventional therapy, i.e. with the following BMRC improvement of at least:`· 18 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC below 40,5 at first run-in period assessment`· . 12 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC between 40.5 and 56 included at first run-in period assessment`· 8 points of their BMRC index at baseline compared to the beginning of the run-in period if BMRC over 56 at first run-in period assessment- Patients with an BMRC index of less than 24 or more than 72.- Patients having received a bolus of methylprednisone within 3 weeks prior to study entry.- Patients with a known allergy to one of the ingredients of the IVIg test product.- Patients with decompensated cardiac insufficiency or any other intercurrent condition that may alter the study conduct.- Patients with positive Coomb`s test at baseline.- Patients who refuse to participate in the study.- Patients who are not able to follow instructions.- Patients who are protected by the law (guardianship, trusteeship).- Patients who have participated in a study within the 3 months prior to study run-in period.- Patients who refuse to give written informed consent.
    - Donne incinte, mamme che allattano, e donne in eta` di procreare senza una contraccezione efficace.- Pazienti con un test di Coomb positivo rispetto ai dati di base.- Pazienti che non soddisfanno i criteri diagnostici dell`ENMC (definito o probabile) per i DM e PM idiopatici. - Pazienti con una diagnosi di DM o PM paraneoplastiche.- DM e PM giovanili (meno di 18 anni).- Pazienti che soffrono di DM senza danni muscolari.- Pazienti con una speranza di vita inferiore a 3 mesi.- Pazienti la cui forza muscolare risponde alla terapia convenzionale, cioe` con il seguente miglioramento di BMRC di almeno:`· 18 punti del loro indice di BMRC al valore di base in confronto all`inizio del periodo di run-in se il BMRC era inferiore a 40.5 alla prima valutazione eseguita durante il periodo di run-in`· 12 punti del loro indice di BMRC al valore di base in confronto all`inizio del periodo di run-in se il BMRC e` compreso tra 40.5 e 56 inclusi alla prima valutazione eseguita durante il periodo di run-in`· 8 punti del loro indice BMRC al valore di base in confronto all`inizio del periodo di run-in se il BMRC e` superiore a 56 alla prima valutazione del periodo di run-in- Pazienti con un indice BMRC inferiore a 24 o superiore a 72.- Pazienti che hanno ricevuto un bolo di metilprednisone nelle 3 settimane che precedono il loro ingresso nello studio.- Pazienti con un`allergia conosciuta ad uno degli ingredienti del prodotto IVIg studiato.- Pazienti con un`insufficienza cardiaca decompensata o qualsiasi altra condizione che potrebbe alterare il proseguimento dello studio.- Pazienti che rifiutano di partecipare allo studio.- Pazienti non in grado di seguire le istruzioni.- Pazienti che sono protetti dalla legge (tutela, curatela).- Pazienti che hanno partecipato ad uno studio nei 3 mesi che precedono il periodo di run-in.- Pazienti che rifiutano di firmare il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    Muscle strength intensity, as defined by the BMRC and modified by Cherin (Cherin et al., 1994), which assigns the grades 0 to 11 to indicate the level of muscle power in 8 muscle groups (neck flexors, trapezius, deltoid, biceps, psoas, maximus and medius gluteus, and quadriceps). BMRC index will be determined by an independent physician/physiotherapist masked to treatment allocation and study visits. Treatment response will be defined as an improvement from baseline of BMRC score at the end of Period I (84 days or earlier in case of significant deterioration as described above) as follows:- Patients with baseline BMRC score between 24 and 40 included: at least 18 points improvement, i.e. an average improvement of more than 2 grades / muscle group (i.e. from patients having contraction with moving initiation to patients having at least moving in the plan).- Patients with baseline BMRC score between 40.5 and 56 included: at least 12 points improvement, i.e. an average improvement of at least 1.5 grades / muscle group (i.e. from patients having moving initiation in the plan, to patients having at least moving against gravity).- Patients with baseline BMRC score between 56.5 and 72 included: at least 8 points improvement, i.e. an average improvement of at least 1 grade / muscle group (i.e. from patients having an incomplete moving against gravity to patients having at least a moving initiation against resistance). Patients prematurely switched from Period I to Period II for BMRC index aggravation will be considered as non-responders.
    Intensita` della forza muscolare, cosi` come e` definita dal British Medical Research Council o BMRC e modificata dal Prof. Cherin (Cherin e Al, 1994), che attribuisce gradi da 0 a 11 a seconda del livello della forza muscolare di 8 gruppi muscolari (flessori del collo, trapezio, deltoide, bicipite, psoas, grande e medio gluteo e quadricipite). Il punteggio BMRC sara` determinato da un medico/fisioterapista indipendente che non conosce ne` il trattamento assegnato al paziente, ne` la visita dello studio. La risposta al trattamento sara` definita da un aumento del punteggio di base del BMRC alla fine del Periodo I (84 giorni o anticipatamente in caso di deterioramento significativo come descritto in precedenza) come segue:* Per i pazienti con un punteggio BMRC rispetto ai dati di base compreso tra 24 e 40 (estremi inclusi): 18 punti di miglioramento, ad es., un miglioramento medio di oltre 2 punti per gruppo muscolare (ad esempio: passaggio della fase di pazienti che hanno una contrazione con un inizio di movimento, alla fase dei pazienti che hanno almeno un movimento nel piano)* Per i pazienti che hanno un punteggio BMRC rispetto ai dati di base compreso tra 40.5 e 56 (estremi inclusi): 12 punti di miglioramento, ad es., un miglioramento medio di 1,5 punti per gruppo muscolare (ad esempio: passaggio della fase dei pazienti che hanno un inizio di movimento nel piano, alla fase del paziente che ha almeno un movimento contro la gravita`)* Per i pazienti che hanno un punteggio BMRC rispetto ai dati di base tra 56.5 e 72 (estremi inclusi): 8 punti di miglioramento, ad es., un miglioramento medio di almeno 1 punto per gruppo muscolare (ad es.: passaggio della fase dei pazienti che hanno un movimento incompleto contro la gravita`, alla fase del paziente che ha almeno un inizio di movimento contro la resistenza).I pazienti che passeranno prematuramente dal periodo I al periodo II a causa di un aggravarsi dell`indice BMRC saranno considerati come non rispondenti.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Treatment response will be defined as an improvement from baseline of BMRC score at the end of Period I (84 days or earlier in case of significant deterioration)
    La risposta al trattamento sara` definita da un aumento del punteggio di base del BMRC alla fine del Periodo I (84 giorni o anticipatamente in caso di deterioramento significativo)
    E.5.2Secondary end point(s)
    - Time course evaluation of muscle strength using BMRC index (run-in period, Period I and Period II). - Physical function recorded by the patients, as measured by the Health Assessment Questionnaire (HAQ) scale. - Global disease activity made by the Investigators, using a visual analog scale (VAS). - Global disease activity made by the patients, using a visual analog scale (VAS). - Serum activity of muscle enzymes: creatine kinase (CK), aldolase, lactate deshydrogenase (LDH). The activity enzymes Aspartate aminotransferase (ASAT) and alanine aminotransferase (ALAT) will be dosed in routine blood laboratory tests. - Measurement outcome as defined by International Myositis Assessment and Clinical Studies Group (IMACS). - Cutaneous signs severity, according to the modified 3-point scale from Göttfried (Göttfried et al., 2000) : 0 = no symptom, 1 = slight heliotrope erythema, scaly eruptions on the knuckles (Gottron’s papules), and/or pruritic hairline and scalp involvement 2 = severe heliotrope erythema, swollen eyelids, splinter hemorrhages, prominent Gottron’s papules, erosions and painful cutaneous ulceration, or necrosis. - Other organ involvement (cardiac, pharyngeal, gastro-intestinal, joint, pulmonary, others) assessed by the Investigators, using clinical and paraclinical examinations. - Consumption of prednisone during the run-in period, Period I and Period II. - Consumption of IS during period II. - Routine blood laboratory tests (haematology, chemistry). - Adverse events.
    - Valutazione dell`evoluzione nel tempo della forza muscolare grazie al punteggio BMRC (periodo di run-in, Periodi I e II). - Funzione fisica valutata dai pazienti, secondo la scala HAQ. - Incidenza globale della malattia valutata dai ricercatori, utilizzando una scala visiva analogica (VAS). - Incidenza globale della malattia valutata dai pazienti, utilizzando una scala visiva analogica (VAS). - Attivita' sierica degli enzimi muscolari: CK, Aldolasi, Lattato deidrogenasi. Le attivita' degli enzimi aspartato aminotransferasi (ASAT) ed alanina amminotransferasi (ALAT) saranno dosati nei test di laboratorio di routine. - Misura dei risultati secondo la definizione del Gruppo: International Myositis Assessment and Clinical Studies Group (IMACS). - Gravita' dei segni cutanei, in base alla scala modificata Göttfried di 3 punti (Göttfried e Al, il 2000): 0 = nessun sintomo, 1 = eritema eliotropo leggero, eruzioni squamose sulle falangi (papule di Gottron), e/o lesione pruriginosa del cuoio capelluto e della sua circonferenza, 2 = eritema eliotropo grave, palpebre gonfiate, emorragie con laccio, papule di Gottron prominenti, erosioni ed ulcerazione cutanea penosa, o necrosi. - Lesione di un altro organo (lesione cardiaca, faringea, gastro-intestinale, articolare, polmonare, altre lesioni) valutate dai ricercatori, secondo esami clinici e paraclinici. - Consumo in prednisone durante il run-in, nel Periodo I e nel Periodo II. - Consumo in IS durante il Periodo II. - Prove di laboratorio di routine (ematologia, biochimica). - Effetti indesiderabili.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints described along with secondary endpoints
    Timepoints described along with secondary endpoints
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-04-21. Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 44
    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 Decision2006-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
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