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    Summary
    EudraCT Number:2012-005686-12
    Sponsor's Protocol Code Number:RD.03.SPR.29107
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-04-11
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-005686-12
    A.3Full title of the trial
    Patient-Reported outcomes of Brimonidine Tartrate 0.5% gel for treatment of severe facial erythema of rosacea
    Von Patienten berichtete Therapieergebnisse von Brimonidintartrat 0,5%Gel zur Behandlung von schwerem Gesichtserythem bei Rosacea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Patient feedback on the treatment of their persistent facial redness
    Aussagen der Patienten über die Behandlung ihre persistente Gesichtsröte
    A.3.2Name or abbreviated title of the trial where available
    PROOF (Patient-Reported Outcomes Of Facial erythema)
    A.4.1Sponsor's protocol code numberRD.03.SPR.29107
    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 SponsorGalderma R&D
    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 supportGalderma R&D
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGalderma R&D
    B.5.2Functional name of contact pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressLes Templiers - 2400 Route des Colles
    B.5.3.2Town/ cityBiot
    B.5.3.3Post code06410
    B.5.3.4CountryFrance
    B.5.4Telephone number33492 38 67 33
    B.5.5Fax number33493 95 71 64
    B.5.6E-mailmay.ma@galderma.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 nameBrimonidine Tartrate (CD07805/47) 0.5% gel
    D.3.2Product code CD07805/47
    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 INNBRIMONIDINE TARTRATE
    D.3.9.1CAS number 70359-46-5
    D.3.9.2Current sponsor codeCD07085/47
    D.3.9.4EV Substance CodeSUB13122MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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.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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Facial Erythema of Rosacea
    Gesichtserythem bei Rosacea
    E.1.1.1Medical condition in easily understood language
    Facial redness
    Gesichtsröte
    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 10039218
    E.1.2Term Rosacea
    E.1.2System Organ Class 10040785 - Skin and subcutaneous 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
    The aim of this study is to evaluate the patients' feedback following the treatment of severe facial redness of rosacea with brimonidine tartrate 0.5% gel compared with placebo
    Ziel der Studie ist, den von Patienten berichteten Erfolg der Behandlung schwerer Gesichtsröte bei Rosacea mit Brimonidintartrat 0.5 % Gel verglichen mit Plazebo zu bewerten
    E.2.2Secondary objectives of the trial
    The efficacy and tolerance of the treatment will be assessed
    Die Wirksamkeit und Verträglichkeit der Behandlung wird untersucht
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible for the study, subjects must fulfil all of the following criteria.
    1. Male or female subjects age of 18 years or older,
    2. A clinical diagnosis of facial rosacea,
    3. A PSA score of 4 (severe) at Baseline prior to the study drug application,
    4. A Clinician’s Erythema Assessment (CEA) score of 3 (moderate) or 4 (severe) at Baseline prior to the study drug application,
    5. Females of childbearing potential with a negative urine pregnancy test (UPT) at Baseline and must practice an effective method of contraception during the study: oral/systemic (injectable, patch, etc.) contraception (must have been on a stable dose for 3 months prior to study entry), intrauterine device, bilateral tubal ligation, strict abstinence, condoms, diaphragms, sponge, spermicides or partner had a vasectomy,
    6. Females of non-childbearing potential, i.e., premenses, post-menopausal (absence of menstrual bleeding for 2 years), hysterectomy, or bilateral ovariectomy, are not required to have a UPT at Baseline,
    7. Subjects willing and capable of complying with the extent and degree required by the protocol,
    8. Subjects understand and sign an Informed Consent Form at Baseline, prior to any investigational procedure being performed.
    Rationale:
    1-4: In order to select a suitable population for the clinical trial
    5-6: Due to limited amount of data on human pregnancy
    7: In order to ensure compliance to the clinical trial
    8: Only subjects who provided written consent/authorisation are allowed to participate in this clinical trial.
    Die Probanden müssen alle der folgenden Kriterien erfüllen, um für die Studie in Frage zu kommen.
    1. Männliche oder weibliche Probanden im Alter von 18 Jahren oder älter,
    2. Klinische Diagnose von Rosacea im Gesicht
    3. PSA-Score von 4 (schwerwiegend) bei Studienbeginn vor Anwendung des Studienmedikaments,
    4. Score der klinischen Erythembewertung von 3 (mäßig) oder 4 (schwerwiegend) bei Studienbeginn vor Anwendung des Studienmedikaments,
    5. Frauen im gebärfähigen Alter müssen vor Studienbeginn einen negativen Urin-Schwangerschaftstest aufweisen und während der Studie eine effektive Verhütungsmethode verwenden: orale/systemische (injizierbar, Patch, usw.) Empfängnisverhütung (sie müssen 3 Monate bis Eintritt in die Studie eine stabile Dosis erhalten haben), Intrauterinpessar, bilaterale Tubenligatur, strikte Enthaltsamkeit, Kondome, Diaphragmen, Schwamm, Spermizide oder Partner mit Vasektomie.
    6. Bei nicht gebärfähigen Frauen, d. h. vor der Menses, postmenopausal (keine Menstruationsblutung für 2 Jahre), Hysterektomie oder bilaterale Ovarektomie, ist bei Studienbeginn kein Urin-Schwangerschaftstest erforderlich.
    7. Probanden müssen willens und in der Lage sein, die Anforderungen des Prüfplans in dem notwendigen Maße zu erfüllen,
    8. Probanden müssen bei Studienbeginn die Einwilligungserklärung verstanden haben und unterzeichnen, bevor Untersuchungsverfahren durchgeführt werden.
    Begründung:
    1-4: Um eine geeignete Population für die klinische Studie auszuwählen
    5-6: Aufgrund des begrenzten Datenmaterials zur Schwangerschaft beim Menschen
    7: Um Compliance mit der klinischen Studie sicherzustellen
    8: Nur Probanden, die eine schriftliche Einwilligung/Genehmigung abgeben, dürfen an dieser klinischen Studie teilnehmen.
    E.4Principal exclusion criteria
    Any subject who meets one or more of the following criteria will not be eligible for the study.
    1. More than 5 facial inflammatory lesions (papules or pustules) of rosacea,
    2. Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that share clinical features with rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia,
    3. Current treatment with monoamine oxidase inhibitors, barbiturates, opiates, sedatives, systemic anaesthetics, or alpha agonists,
    4. Less than 3 months stable dose treatment for inflammatory lesions of rosacea, tricyclic anti-depressants, cardiac glycosides, beta blockers or other antihypertensive agents,
    5. Current diagnosis of Raynaud’s syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren’s syndrome, or depression,
    6. Any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or put the subject at significant risk if the subject participates in the clinical trial as judged by the investigator,
    7. Known or suspected allergies or sensitivities to any component of the study drugs, including the active ingredient brimonidine tartrate (see Investigator’s Brochure),
    8. The subject has received, applied or taken the following treatments within the specified time frame prior to the Day 1 visit:
    Topical facial treatments or procedures:
    -Any dermatologic/surgical procedure on the face: 4 weeks
    -Prescription medications that are indicated, wholly or in part, as a treatment for erythema of rosacea: 4 weeks
    -Prescription medications for treatment of acne: 4 weeks
    -Immunomodulators: 4 weeks
    -Corticosteroids: 4 weeks
    -Antibiotics other than those intended for the treatment of inflammatory lesions of rosacea: 2 weeks
    -OTC medications for treatment of acne: 1 week
    -Astringents or abrasives: 2 days
    Systemic treatments:
    -Isotretinoin: 6 months
    -Immunomodulators: 12 weeks
    -Prescription medications that are indicated, wholly or in part, as a treatment for erythema of rosacea:
    4 weeks
    -Prescription medications for treatment of acne: 4 weeks
    -Corticosteroids (oral or injectable): 4 weeks
    -Phototherapy: 4 weeks
    -Antibiotics other than those intended for the treatment of inflammatory lesions of rosacea: 4 weeks
    -Prescription anti-inflammatory medications: 2 weeks
    -Chronic, daily use of OTC anti-inflammatory medications (e.g. ibuprofen, naproxen) for more than 1 week (does not include low-dose aspirin for cardiac prophylaxis: 1 week
    -Niacin ≥500 mg per day: 1 week
    9. Female who is pregnant or lactating,
    10. Exposed to excessive ultraviolet (UV) radiation within one week prior to the Day 1 visit,
    11. Presence of beard or excessive facial hair on Day 1, which would interfere with the study treatments or study assessments and refusal to remove for duration of the study,
    12. Prior treatment with brimonidine tartrate gel,
    13. Current treatment with brimonidine tartrate ophthalmic solution,
    14. Current treatment with any topical facial formulation containing brimonidine tartrate or oxymetazoline,
    15. Subjects unwilling to refrain from use of prohibited medication or excessive exposition to UV during the course of the study,
    16. Vulnerable subjects (such as deprived from freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP),
    17. Current participation in any other clinical trial of a drug or device OR participated within 30 days prior to Day 1 OR in an exclusion period from a previous clinical trial (when possible).
    Rationale:
    1, 2: In order to select subjects with suitable rosacea severity and avoid any interference or confounding factors with evaluation
    3-7: To avoid potential safety concerns with use of the study drug
    8, 10-15: To avoid any interference or confounding factors with the study outcomes and interpretation of results
    9: Due to limited amount of data regarding human pregnancy or lack of data about the brimonidine excretion in human milk
    16-17: To comply with ICH-GCP
    Alle Probanden, die ein oder mehrere der folgenden Kriterien erfüllen, können für die Studie nicht berücksichtigt werden.
    1.Mehr als 5 entzündliche Läsionen (Papeln oder Pusteln) der Rosacea im Gesicht
    2.Spezielle Formen der Rosacea (Rosacea conglobata, Rosacea fulminans, isoliertes Rhinophym, isolierte Pusteln am Kinn) oder sonstige begleitende Dermatosen im Gesicht, die klinische Gemeinsamkeiten mit Rosacea aufweisen, wie periorale Dermatitis, Demodikose, Keratosis pilaris im Gesicht, seborrhoische Dermatitis, akuter Lupus erythematodes oder aktinische Teleangiektasien,
    3.Derzeitige Behandlung mit Monoaminoxidase-Hemmern, Barbituraten, Opiaten, Sedativa, systemischen Anästhetika oder Alpha-Agonisten,
    4.Weniger als 3 Monate Behandlung mit stabiler Dosis für entzündliche Läsionen von Rosacea, trizyklischen Antidepressiva, Herzglykosiden, Betablockern oder anderen Antihypertonika,
    5.Aktuelle Diagnose von Raynaud-Syndrom, Thromboangiitis obliterans, orthostatischer Hypotonie, schwerer kardiovaskulärer Erkrankung, zerebrovaskulärer oder koronarer Insuffizienz, Funktionsstörungen von Niere oder Leber, Sklerodermie, Sjögren-Syndrom oder Depression,
    6.Alle nicht therapierten chronischen oder schwerwiegenden Erkrankungen oder nicht therapierten medizinischen Zuständen, welche die Interpretation der Ergebnisse der klinischen Studie beeinträchtigen können oder bei Teilnahme an der klinischen Studie ein signifikantes Risiko für den Probanden darstellen, wobei die Beurteilung durch den Prüfarzt erfolgt,
    7.Bekannte oder vermutete Allergien oder Empfindlichkeiten gegenüber den Komponenten der Prüfmedikamente, einschließlich des Wirkstoffs Brimonidintartrat (siehe Informationen für den Prüfer),
    8.Der Proband hat die folgenden Behandlungen innerhalb des angegebenen Zeitraums vor dem Besuchstermin am ersten Tag erhalten, angewendet oder eingenommen:
    -Topische Behandlungen oder Maßnahmen im Gesicht:
    -Jegliche dermatologischen/chirurgischen Maßnahmen im Gesicht:4 Wochen
    -Verschreibungspflichtige Medikamente, die ganz oder teilweise als Behandlung des Erythems der Rosacea indiziert sind:4 Wochen
    -Verschreibungspflichtige Medikamente zur Behandlung von Akne:4 Wochen
    -Immunmodulatoren:4 Wochen
    -Kortikosteroide:4 Wochen
    -Andere Antibiotika als solche, die zur Behandlung der entzündlichen Läsionen der Rosacea vorgesehen sind:2 Wochen
    -Frei verkäufliche Medikamente zur Behandlung von Akne:1 Woche
    -Adstringenzien oder Abrasiva:2 Tage
    Systemische Behandlungen:
    -Isotretinoin:6 Monate
    -Immunmodulatoren:12 Wochen
    -Verschreibungspflichtige Medikamente, die ganz oder teilweise als Behandlung des Erythems der Rosacea indiziert sind:4 Wochen
    -Verschreibungspflichtige Medikamente zur Behandlung von Akne:4 Wochen
    -Kortikosteroide (oral oder injizierbar):4 Wochen
    -Phototherapie:4 Wochen
    -Andere Antibiotika als solche, die zur Behandlung der entzündlichen Läsionen der Rosacea vorgesehen sind:4 Wochen
    -Verschreibungspflichtige Antiphlogistika:2 Wochen
    Chronische tägliche Verwendung von frei verkäuflichen Antiphlogistika (z. B. Ibuprofen, Naproxen) für mehr als 1 Woche (schließt niedrig dosiertes Aspirin zur Prophylaxe von Herzkrankheiten nicht ein):1 Woche
    -Niacin ≥ 500 mg pro Tag:1 Woche
    9.Schwangere oder stillende Frauen,
    10.Exzessive Exposition gegenüber ultravioletter (UV)-Strahlung innerhalb einer Woche vor dem Termin am ersten Tag,
    11.Vorhandensein eines Bartes oder übermäßiger Gesichtsbehaarung am ersten Tag, wodurch die Studienbehandlungen oder Studienbeurteilungen beeinträchtigt würden, und Weigerung, diese(n) für die Dauer der Studie abzunehmen,
    12.Vorherige Behandlung mit Brimonidintartrat-Gel,
    13.Derzeitige Behandlung mit Brimonidintartrat-Augentropfen,
    14.Derzeitige Behandlung mit jeder topischen Formulierung für das Gesicht, die Brimonidintartrat oder Oxymetazolin enthält,
    15.Probanden, die auf die Verwendung untersagter Medikamente oder exzessiver UV-Exposition während der Dauer der Studie nicht verzichten möchten,
    16.Besonders schutzbedürftige Probanden (wie im Strafvollzug) gemäß der Definition in Abschnitt 1.61 der internationalen Harmonisierungskonferenz "Internetional Conference on Harmonisation (ICH)" zu Leitlinien der guten klinischen Praxis (Good Clinical Practice (GCP)),
    17.Aktuelle Teilnahme an anderen klinischen Studien zu einem Medikament oder Medizinprodukt ODER Teilnahme innerhalb von 30 Tagen vor dem ersten Tag ODER innerhalb eines Ausschlusszeitraums von einer vorhergehenden klinischen Studie (wenn möglich).
    E.5 End points
    E.5.1Primary end point(s)
    There is no primary endpoint in the study, as this is an exploratory study and no previous analysis on patient-reported outcomes of brimonidine tartrate 0.5% gel exists for the calculation of sample size. Variables to be analysed in the study include the following:

    Patient-reported outcomes:
    • Dermatology Life Quality Index questionnaire at each visit
    • Facial Redness questionnaire at each visit
    • EuroQol-5 Dimension questionnaire at each visit
    • Subject Satisfaction questionnaire at the end of the study
    Efficacy variables:
    • Severity of erythema according to participants before and 3 hours after application of study drug
    • Severity of erythema according to study doctors before and 3 hours after application of study drug
    Safety variable:
    • Incidence of adverse event
    Diese Studie verfügt nicht über einen primären Endpunkt, da es sich um eine explorative Studie handelt und noch keine vorhergehende Analyse der von Patienten berichteten Therapieergebnisse von 0,5 % Brimonidintartrat-Gel für die Berechnung der Stichprobengröße vorliegen. Folgende Variablen sind in der Studie zu analysieren:

    Von Patienten berichtete Therapieergebnisse:
    • Fragebogen zum dermatologischen Lebensqualitätsindex bei jedem Termin
    • Fragebogen zur Gesichtsrötung bei jedem Termin
    • Fragebogen zur EuroQol-5 Dimension bei jedem Termin
    • Fragebogen zur Zufriedenheit des Probanden am Ende der Studie
    Wirksamkeitsvariablen:
    • Schwere des Erythems gemäß Teilnehmerangaben vor und 3 Stunden nach Auftragen des Prüfmedikaments
    • Schweregrad des Erythems gemäß Prüfärzten vor und 3 Stunden nach Auftragen des Prüfmedikaments
    Sicherheitsvariable:
    • Inzidenz unerwünschter Ereignisse
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable
    nicht zutreffend
    E.5.2Secondary end point(s)
    Not applicable
    nicht zutreffend
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    nicht zutreffend
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient-reported outcomes
    Die von Patienten berichteten Therapieergebnisse
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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
    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 months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state42
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    None
    keine
    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 Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-11-19
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    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.

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