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    Summary
    EudraCT Number:2011-003059-20
    Sponsor's Protocol Code Number:EMR700692_006
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-06-19
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2011-003059-20
    A.3Full title of the trial
    A multicenter, randomized, double-blind, placebo-controlled, parallel-group trial to investigate the efficacy and safety of different intra-articular (i.a.) dosages of sprifermin in subjects with primary osteoarthritis of the knee (FORWARD)
    Wieloośrodkowe, randomizowane, podwójnie zaślepione z kontrolowanym placebo, prowadzone w grupach równoległych badanie, mające na celu ocenę skuteczności i bezpieczeństwa różnych dawek leku Sprifermin podawanego dostawowo u pacjentów z pierwotną chorobą zwyrodnieniową stawu kolanowego (FORWARD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and effectiveness of different doses of a new drug (sprifermin- also called AS902330) in patients with osteoarthritis of the knee
    A.3.2Name or abbreviated title of the trial where available
    FORWARD
    A.4.1Sponsor's protocol code numberEMR700692_006
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Centre Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Straße 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+496151725200
    B.5.5Fax number+496151722000
    B.5.6E-mailservice@merckgroup.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 nameSprifermin 100 mcg
    D.3.2Product code AS902330 100 mcg
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSprifermin
    D.3.9.2Current sponsor codeAS902330
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 nameSprifermin 30 mcg
    D.3.2Product code AS902330 30 mcg
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSprifermin
    D.3.9.2Current sponsor codeAS902330
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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 placeboPowder and solvent for solution for injection
    D.8.4Route of administration of the placeboIntraarticular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary osteoarthritis
    E.1.1.1Medical condition in easily understood language
    A disease characterized by deterioration of cartilage and its underlying bone within a joint.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10023476
    E.1.2Term Knee osteoarthritis
    E.1.2System Organ Class 100000004859
    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 structural changes in cartilage thickness in the total femorotibial joint of the target knee in terms of imaging by magnetic resonance imaging (MRI)
    Ocena zmian w strukturze chrząstki stawu udowo-piszczelowego leczonego kolana za pomocą obrazowania metodą rezonansu magnetycznego (MRI).
    E.2.2Secondary objectives of the trial
    * To evaluate different dose regimens of sprifermin
    * To evaluate changes in symptoms of osteoarthritis (OA)
    * To evaluate changes in structure in terms of imaging by X-ray
    * To evaluate other changes in cartilage morphology in terms of imaging by MRI (sub-regions)
    * To evaluate changes in physical functioning
    * To evaluate the safety of sprifermin
    * To evaluate the pharmacokinetics (PK) of sprifermin in serum and in synovial fluid following i.a. injection
    * ocena różnych schematów dawkowania produktu badanego sprifermin
    * ocena zmiany objawów choroby zwyrodnieniowej stawów (OA)
    * ocena zmian strukturalnych za pomocą promieniowania rentgenowskiego (RTG)
    * ocena innych zmian w morfologii chrząstki stawowej za pomocą MRI (podregiony)
    * ocena zmiany sprawności fizycznej
    * ocena bezpieczeństwa stosowania produktu sprifermin
    * ocena farmakokinetyki (PK) produktu sprifermin w surowicy i mazi stawowej po iniekcji
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The trial will enroll adult subjects of either sex with primary femorotibial osteoarthritis according to American College of Rheumatology (ACR) clinical and radiographic criteria who have Kellgren-Lawrence grades of 2 or 3 and a minimum joint space width (JSW) of ≥ 2.5 mm in the medial compartment.

    Subjects must have pain in the target knee on most days and/or require symptomatic treatment of knee pain with paracetamol (acetaminophen), systemic non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2 selective inhibitor (coxibs), or tramadol on most days of the previous month, and must have both:
    * A history of pain due to OA in the target knee for at least 6 months, and
    * Pain score for the target knee of 4 to 9 points in response to Question 1 of the WOMAC pain index(“how much pain have you had [in the target knee, over the past 48 hours] when walking on a flat
    surface?”) at screening and baseline, after washout of at least 5-half-lives of analgesic medication(s): acetaminophen, topical or oral systemic NSAIDS, coxibs, opioids, and/or tramadol.

    Women of childbearing potential must use a form of contraception with a failure rate of less than 1% per year throughout the trial.
    Do badania włączeni zostaną dorośli pacjenci obojga płci z pierwotną chorobą zwyrodnieniową stawu udowo-piszczelowego zgodnie z klinicznymi i radiograficznymi kryteriami Amerykańskiego Kolegium Reumatologicznego (American College of Rheumatology – ACR), którzy mają 2 lub 3 stopień zaawansowania zmian chorobowych w skali Kellgrena-Lawrence’a i minimalną szerokość szpary stawowej (joint space width – JSW) ≥ 2,5 mm w komorze przyśrodkowej.

    Pacjenci muszą doświadczać dolegliwości bólowych w badanym kolanie przez większość dni i/lub wymagać leczenia objawowego bólu kolana za pomocą paracetamolu (acetaminofenu), ogólnoustrojowych niesteroidowych leków przeciwzapalnych (NLPZ) włączając w to wybiórcze inhibitory COX-2 (koksyby), lub tramadolu przez większość dni minionego miesiąca, ponadto muszą spełniać oba poniższe warunki:
    * Historia dolegliwości bólowych w leczonym stawie kolanowym wywołanych chorobą zwyrodnieniową od co najmniej 6 miesięcy, oraz
    * Ocena bólu w badanym kolanie od 4 do 9 punktów w odpowiedzi na pytanie 1 wskaźnika bólu WOMAC („jak duże miałeś dolegliwości bólowe [w badanym kolanie, w ciągu ostatnich 48 godzin] podczas chodzenia po płaskiej powierzchni?”) podczas badań przesiewowych i wizyty początkowej, po trwającym co najmniej 5 okresów półtrwania okresie wymywania przyjmowanych leków przeciwbólowych: acetaminofenu, miejscowych lub doustnych ogólnoustrojowych NLPZ, koksybów, opioidów i/lub tramadolu

    Kobiety w wieku rozrodczym podczas całego badania muszą stosować formę antykoncepcyjną ze wskaźnikiem zawodności poniżej 1% rocznie.
    E.4Principal exclusion criteria
    Main exclusion criteria are malalignment of > 5 degrees in the femorotibial axis of the target knee, clinical signs of inflammation (i.e., redness) in the target knee, i.a. administration of corticosteroids or hyaluronic acid into either knee within 6 months before screening, any plan for knee surgery (affecting either the target or the contralateral knee) within the next two years, concomitant conditions or treatments deemed to be incompatible with trial participation, contraindications to MRI scanning (including inability to fit in the scanner or knee coil), pregnancy or breastfeeding, participation in another clinical trial within the past 30 days, and legal incapacity or limited legal capacity.
    Główne kryteria wyłączenia to przemieszczenie > 5 stopni w osi stawu udowo-piszczelowego badanego kolana, objawy kliniczne zapalenia (tj. zaczerwienienie) badanego kolana, dostawowe podanie kortykosteroidów lub kwasu hialuronowego w którekolwiek kolano w ciągu 6 miesięcy przed badaniami przesiewowymi, jakakolwiek planowana operacja kolana (dotyczy obu kolan) w ciągu najbliższych dwóch lat, schorzenia lub leczenie towarzyszące uznane za niekompatybilne z udziałem w badaniu, przeciwwskazania do wykonania MRI (włączając niemożność wykonania badania ze względu na cechy fizyczne pacjenta), ciąża lub karmienie piersią, udział w innym badaniu klinicznym w ciągu ostatnich 30 dni, oraz niezdolność prawna lub ograniczenie zdolności prawnej.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in cartilage thickness in the total femorotibial joint as evaluated by MRI at 2 years
    Zmiana od wartości początkowej grubości tkanki chrzęstnej stawu udowo-piszczelowego oceniana za pomocą obrazowania metodą MRI po 2 latach.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 2 years
    po 2 latach
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are:
    * Changes from baseline in the WOMAC total score and in the WOMAC pain, function, and stiffness index scores over 2 years
    * Change from baseline in the 20-meter walk test over 2 years
    * Change from baseline in the PGA over 2 years
    * Change from baseline in minimal joint space width in the medial and lateral compartments as evaluated by X-ray over 2 years
    * Change from baseline in cartilage thickness in the medial and lateral compartments as well as in the total femorotibial joint over 2 years
    * Change from baseline in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint over 2 years
    * Synovial fluid levels of sprifermin/FGF-18
    * Serum levels of sprifermin/FGF-18

    Safety endpoints are:
    * Nature, incidence and severity of local and systemic AEs
    * Incidence of acute inflammatory reactions (AIRs), defined as increase of pain by 30 mm on a 100 mm
    visual analogue scale (VAS) and a self-reported synovial fluid effusion (i.e., joint swelling) within 3 days following i.a. injection
    * Changes in laboratory safety parameters, vital signs, 12-lead electrocardiogram (ECG) parameters, weight, and physical examinations
    * Incidence of surgical interventions in the target knee (including any surgical revision, cartilage removal, or any other type of surgical intervention).
    * Occurrence of binding and neutralizing antibodies to sprifermin/FGF-18
    Drugorzędowe punkty końcowe:
    * Zmiany od wartości początkowej w punktacji całkowitej skali WOMAC oraz zmiany wskaźnika bólu, wykonywania czynności życia codziennego i sztywności stawów w skali WOMAC w ciągu 2 lat
    * Zmiana od wartości początkowej w 20-metrowym teście chodzenia przez 2 lata
    * Zmiana od wartości początkowej w PGA w ciągu 2 lat
    * Zmiana od wartości początkowej minimalnej szerokości szpary stawowej w przyśrodkowej i bocznej komorze oceniana za pomocą RTG w ciągu 2 lat
    * Zmiana od wartości początkowej grubości tkanki chrzęstnej w przyśrodkowej i bocznej komorze, a także w całkowitej strukturze stawu udowo-piszczelowego w ciągu 2 lat
    * Zmiana od wartości początkowej objętości tkanki chrzęstnej w przyśrodkowej i bocznej komorze, a także w całkowitej strukturze stawu udowo-piszczelowego w ciągu 2 lat
    * Stężenie sprifermin/FGF-18 w mazi stawowej
    * Stężenie sprifermin/FGF-18 w surowicy

    Końcowe punkty bezpieczeństwa:
    * Rodzaj, częstość występowania i nasilenie lokalnych i ogólnoustrojowych zdarzeń niepożądanych (AE)
    * Częstość występowania ostrych reakcji zapalnych (acute inflammatory reactions – AIRs), które określa się jako wzrost bólu o 30 mm na 100 mm w wizualnej skali analogowej (VAS) powiązanego ze zgłaszanym przez pacjenta wysiękiem płynu stawowego (czyli obrzęk stawów) w ciągu 3 dni po iniekcji odstawowej
    * Zmiany w laboratoryjnych parametrach bezpieczeństwa, parametrach życiowych, odczytach 12-kanałowego EKG, wadze i badaniach fizykalnych
    * Przeprowadzenie interwencji chirurgicznych w obrębie badanego kolana (włączając w to jakiekolwiek korekty chirurgiczne, usunięcie chrząstki lub inne rodzaje interwencji chirurgicznych)
    * Występowanie wiążących i neutralizujących przeciwciał FGF-18
    E.5.2.1Timepoint(s) of evaluation of this end point
    DBPC phase:
    * Changes from baseline in the WOMAC total score and in the WOMAC pain, function, and stiffness: over 2 years
    * Change from baseline in the 20-meter walk test: over 2 years
    * Change from baseline in the PGA: over 2 years
    * Change from baseline in minimal joint space width in the medial and lateral compartments as by X-ray: over 2 years
    * Change from baseline in cartilage thickness in the medial and lateral compartments: over 2 years
    * Change from baseline in cartilage volume in the medial and lateral compartments as well as in the total femorotibial joint: over 2 years
    * Synovial fluid levels of sprifermin/FGF-18: at W0, W1, W2, W26, W27 and W28
    * PK Serum collection: W0, W2 and W28
    * AEs: Continuous
    Faza DBPC:
    *Zmiany od wart. pocz. w punktacji WOMAC oraz zmiany wskaźnika bólu, wykonywania czynności życia codziennego i sztywności stawów w skali WOMAC: w ciągu 2 lat
    *Zmiana od wart. pocz. w 20-m. teście chodzenia: w ciągu 2 lat
    *Zmiana od wart. pocz. w PGA: w ciągu 2 lat
    *Zmiana od wart. pocz. minimalnej szerokości szpary stawowej w przyśrodkowej i bocznej komorze oceniana za pomocą RTG: w ciągu 2 lat
    *Zmiana od wartości początkowej grubości tkanki chrzęstnej w przyśrodkowej i bocznej komorze: w ciągu 2 lat
    *Zmiana od wart. począ. objętości tkanki chrzęstnej w przyśrodkowej i bocznej komorze, oraz w całk. strukturze stawu udowo-piszczelowego: w ciągu 2 lat
    *Stężenie sprifermin/FGF-18 w mazi stawowej i w surowicy: na wiz. 0, 1, 2, 26, 27 i 28
    *PK: wiz. 0, 2, 28
    *AE: ciągłe
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.2.4Number of treatment arms in the trial5
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Czech Republic
    Denmark
    Estonia
    Hong Kong
    Poland
    Romania
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    For administrative and safety reporting purposes, the end of the trial will be defined as the date
    of the final clinical database lock at the end of the extended follow-up phase. This provides for a
    single and conservative definition across all trial sites.
    Dla potrzeb administracyjnych i raportowania bezpieczeństwa, data zakończenia badania zostanie zdefiniowana jako ostateczna data zamknięcia bazy danych z badania klinicznego na zakończenie przedłużonego okresu kontrolnego. Zapewni to jednolitą definicję zakończenia badania we wszystkich ośrodkach badawczych.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months1
    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.1.1.1In 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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 275
    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
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 452
    F.4.2.2In the whole clinical trial 545
    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)
    Subjects who have completed the trial or have withdrawn early should be managed in accordance with the Investigator's clinical judgement, as appropriate for each subject's individual medical needs.
    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 Decision2013-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-07
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