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    Summary
    EudraCT Number:2011-006236-23
    Sponsor's Protocol Code Number:311-09
    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:2012-04-17
    Trial 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 number2011-006236-23
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis.
    Randomizowane, podwójnie zaślepione, kontrolowane placebo, trójramienne, prowadzone w grupach równoległych, wieloośrodkowe badanie równoważności terapeutycznej dwóch preparatów Takrolimus 0,1% w maści stosowanej miejscowo u dorosłych pacjentów cierpiących na atopowe zapalenie skóry w postaci umiarkowanej lub ciężkiej
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Randomized, Double-Blind, Placebo-controlled, Three-arm, Parallel Assignment, Multi-centre, Therapeutic Equivalence Study of Two Tacrolimus 0.1% Topical Ointment Formulations in Adult Patients with Moderate to Severe Atopic Dermatitis
    Randomizowane, podwójnie zaślepione, kontrolowane placebo, trójramienne, prowadzone w grupach równoległych, wieloośrodkowe badanie równoważności terapeutycznej dwóch preparatów Takrolimus 0,1% w maści stosowanej miejscowo u dorosłych pacjentów cierpiących na atopowe zapalenie skóry w postaci umiarkowanej lub ciężkiej
    A.4.1Sponsor's protocol code number311-09
    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 SponsorAccord Healthcare Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAccord Healthcare Ltd.
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportIntas Pharmaceuticals Ltd.
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLambda Therapeutic Research Sp. z o. o.
    B.5.2Functional name of contact pointClinical Trial Managment
    B.5.3 Address:
    B.5.3.1Street AddressTasmowa 7
    B.5.3.2Town/ cityWarsaw
    B.5.3.3Post code02-677
    B.5.3.4CountryPoland
    B.5.4Telephone number48225772800
    B.5.5Fax number48225772801
    B.5.6E-mailezyto@lambda-cro.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 nameTacrolimus Ointment 0.1%
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTacrolimus
    D.3.9.1CAS number 109581-93-3
    D.3.9.2Current sponsor codeTacrolimus 0.1%
    D.3.9.3Other descriptive nameTACROLIMUS MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23141
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Protopic 0.1% ointment
    D.2.1.1.2Name of the Marketing Authorisation holderAstellas Pharma Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameProtopic 0.1% ointment
    D.3.4Pharmaceutical form Ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTacrolimus
    D.3.9.1CAS number 109581-93-3
    D.3.9.3Other descriptive nameTACROLIMUS MONOHYDRATE
    D.3.9.4EV Substance CodeSUB23141
    D.3.10 Strength
    D.3.10.1Concentration unit % (W/W) percent weight/weight
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboOintment
    D.8.4Route of administration of the placeboTopical use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    moderate to severe atopic dermatitis
    umiarkowana do ciężkiej postać atopowego zapalenia skóry
    E.1.1.1Medical condition in easily understood language
    moderate to severe atopic dermatitis
    umiarkowana do ciężkiej postać atopowego zapalenia skóry
    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 17.0
    E.1.2Level PT
    E.1.2Classification code 10012438
    E.1.2Term Dermatitis atopic
    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 primary objective is to establish the therapeutic equivalence between tacrolimus ointment 0.1%, manufactured by Intas Pharmaceuticals Ltd., India and Protopic® (tacrolimus), 0.1% topical ointment manufactured by Astellas Pharma B.V., The Netherlands and marketed by Astellas Pharma Europe Ltd. and to show superiority over vehicle in the treatment of moderate to severe Atopic Dermatitis in adult population.
    Celem podstawowym badania jest ustalenie terapeutycznej równoważności pomiędzy maścią tacrolimus 0,1%, produkowana przez Intas Pharmaceuticals Ltd., Indie, a maścią Protopic® (tacrolimus), 0,1% produkcji Asetellas Pharma B.V., Holandia, wprowadzoną do obrotu przez Asetllas Pharma Europe Ltd. Oraz pokazanie wyższości terapeutycznej danego podłoża w leczeniu postaci umiarkowanej do ciężkiej atopowego zapalenia skóry u dorosłych.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at anticipated Cmax.
    Celem wtórnym badania jest porównanie profili zdarzeń niepożądanych dla obu maści oraz ocena ich wchłaniania do krwioobiegu w przewidywanych wartościach Cmax.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or non-pregnant, non-lactating female of any ethnic group, 18 – 70 years of age (both inclusive) at the time of signing the informed consent.
    2. Patients having atopic dermatitis according to Hanifin and Rajka diagnostic criteria (Appendix I).
    3. Patients with a grading of moderate to severe AD (i.e. a score of at least 4.5) as defined by the scoring system of Rajka and Langeland (Appendix II).
    4. Non-immunocompromised adults who have failed to respond adequately to other topical prescription treatments for AD, or when those treatments are not advisable in the opinion of the Investigator.
    5. Last application of medicated topical agents, intake of systemic antihistamines, intranasal or inhaled corticosteroids (> 1 mg/day) should be minimum 7 days prior to randomization.
    6. Last application of tacrolimus ointment, intake of systemic corticosteroids and nonsteroidal immunosuppressants should be minimum 3 weeks prior to randomization.
    7. Both male and female patients of child bearing potential must be practicing adequate contraception and female patients of child-bearing potential must not be pregnant or lactating and must have a negative serum pregnancy test at screening and negative urine pregnancy test at randomization.
    8. Patient is capable of understanding the purposes and risks of the trial and has given written informed consent, which includes compliance with the study requirements and restrictions listed in the consent form.
    9. Patient has not taken and agrees not to take any medication or therapy prohibited by the protocol for the entire study period.
    1. Mężczyźni lub kobiety nie będące w ciąży, kobiety nie karmiące, z dowolnej grupy etnicznej, w wieku 18-70 lat (włącznie) w momencie podpisania świadomej zgody.
    2. Pacjenci cierpiący na atopowe zapalenie skóry według kryteriów diagnostycznych Hanifin i Rajka (Załącznik I).
    3. Pacjenci z umiarkowaną do ciężkiej postacią AZS (co najmniej 4,5 punktów skali) według systemu klasyfikacji Rajka i Langelanda (Załącznik II).
    4. Pacjenci bez deficytu odporności po niepowodzeniu wcześniejszej terapii miejscowej lub pacjenci, u których terapia ta w opinii Badacza nie jest wskazana.
    5. Ostatnia aplikacja leków miejscowych, doustnych leków antyhistaminowych oraz donosowych i wziewnych kortykosteroidów (w dawkach powyżej 1 mg/dzień) powinna mieć miejsce co najmniej 7-dni przed randomizacją.
    6. Ostatnia aplikacja maści takrolimus, doustnych kortykosteroidów lub niesteroidowych immunosupresantów powinna mieć miejsce nie wcześniej niż 3 tygodnie przed randomizacją.
    7. Mężczyźni oraz kobiety w okresie rozrodczym powinni stosować odpowiednią metodę antykoncepcyjną; kobiety w okresie rozrodczym nie mogą być w ciąży ani karmić i muszą uzyskać na wizycie przesiewowej negatywny wynik badania krwi pod kątem ciąży oraz negatywny wynik badania moczu pod kątem ciąży na wizycie randomizacyjnej.
    8. Pacjent jest zdolny do zrozumienia celów i ryzyka związanego z badaniem i wyraził zgodę na udział w badaniu poprzez podpisanie formularz świadomej zgody zawierającego listę wymagań i ograniczeń jakie stawia badanie.
    9. Pacjent nie przyjmował i zgodził się przez cały okres trwania badania nie przyjmować żadnych leków ani nie poddawać się terapiom zabronionym przez protokół badania.
    E.4Principal exclusion criteria
    1. Newly diagnosed or Treatment naïve patients.
    2. Patients with mild (Rajka and Langeland score of < 4.5) or very severe atopic dermatitis that requires systemic therapy.
    3. Patients in need of undergoing UV treatments for AD.
    4. Clinically infected atopic dermatitis at the baseline visit.
    5. Any deermatological condition other than atopic dermatitis as scar/wound/tattoo at the application site or in its close vicinity that in the Investigator's opinion may interfere with the evaluation of the patient's atopic dermatitis
    6. History of allergy or hypersensitivity to tacrolimus or any of the ointment excipients, pimecrolimus, any macrolides such as clindamycin, erythromycin, azithromycin, clarithyromycin etc.

    7. History or known case of congenital or acquired immunodeficiencies, which in the Investigator’s opinion would contraindicate the use of immunosuppressants, including but not limited to human immunodeficiency virus (HIV) infection and cancer.
    8. Patient with a known case of genetic epidermal barrier defect such as Netherton’s syndrome or generalised erythroderma.

    9. Patients with a known case of Cushing’s syndrome.
    10. Patients with diagnosed hepatic failure:
    Serum bilirubin ≥ 1.5 times ULN
    Serum AST/ALT ≥ 2.5 times ULN
    11. Abnormal baseline findings considered by the Investigator to indicate conditions that might affect study endpoints.
    12. Any form of substance abuse (including drug or alcohol abuse), psychiatric disorder or condition which, in the opinion of the Investigator, may invalidate the communication with the Investigator or adversely affect the study outcome.
    13. Positive urine drug scan at screening visit for drugs likely to cause abuse.
    14. Last participation in any other clinical study involving investigational medicinal product within 60 days of randomization. However, it is at the sole discretion of the Investigator to enroll eligible patients considering elimination half-life of such study drug of last participation and/or pharmacokinetic profile of such drug molecule of last participation and/or other medical judgement (if any) to justify the subject’s participation.
    15. Clinically unstable laboratory test results or any other condition that, in the Investigator’s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
    1. Nowo zdiagnozowani oraz nie leczeni pacjenci.
    2. Pacjenci cierpiący na łagodną (według Rajka i Langelanda mniej niż 4,5 punktów skali) lub bardzo ciężką postać AZS, która wymaga terapii doustnej.
    3. Pacjenci kwalifikujący się do leczenia AZS promieniami UV.
    4. Pacjenci wykazujący kliniczne objawy zakażenia w miejscu występowania AZS, zaobserwowane na wizycie wstępnej.

    5. Pacjenci posiadający inną niż AZS zmianę (bliznę, ranę lub tatuaż) w miejscu aplikacji lub jego bezpośrednim sąsiedztwie, która w opinii badacza może utrudnić ocenę stanu atopowego zapalenia skóry.
    6. Pacjenci, którzy w wywiadzie zgłaszają alergię lub nadwrażliwość na takrolimus lub którąkolwiek z substancji pomocniczych, pimekrolimus, którykolwiek z makrolidów (klindamycyna, erytromycyna, azytromycyna, klarytromycyna i inne).
    7. Pacjenci, którzy w wywiadzie zgłaszają wrodzony lub nabyty niedobór odporności, który w opinii badacza jest przeciwwskazaniem do stosowania leków immunosupresyjnych; włączając, zakażenie ludzkim wirusem upośledzenia odporności (HIV) oraz nowotwór.
    8. Pacjenci ze zdiagnozowanym genetycznym defektem bariery naskórkowej, takim jak zespół Nethertona lub uogólniona erytrodermia.
    9. Pacjenci ze zdiagnozowanym zespołem Cushinga.
    10. Pacjenci z niewydolnością wątroby:

    Stężenie bilirubiny ≥ 1.5 razy powyżej górnej granicy normy
    Stężenie AST/ALT ≥ 2.5 razy powyżej górnej granicy normy

    11. Odchylenia od norm zdrowotnych, które w opinii badacza mogłyby wpłynąć na punkty końcowe badania badania.
    12. Dowolna forma uzależnienia (włączając uzależnienie od narkotyków i alkoholu), zaburzenia psychiczne lub inne powody, które w opinii badacza mogłyby zaburzyć komunikację z pacjentem lub niekorzystnie wpłynąć na wynik badania.
    13. Pozytywny wynik przeprowadzonych na wizycie przesiewowej testów narkotykowych na obecność leków o potencjale uzależniającym.
    14. Uczestnictwo w innym badaniu klinicznym z udziałem badanego produktu leczniczego w ciągu 60 dni przed randomizacją. Jednak w wyłącznej gestii badacza pozostaje zakwalifikowanie pacjenta, mając na uwadze okres półtrwania takiego leku i/lub profil farmakokinetyczny cząsteczki i/lub inne orzeczenie lekarskie (jeżeli występuje), uzasadniające udział pacjenta.


    15. Klinicznie niestabilne wyniki badań laboratoryjnych lub inne dowolne warunki zdrowotne, które w opinii badacza mogą zwiększyć ryzyko dla pacjenta lub zmniejszyć szanse na uzyskanie wartościowych danych potrzebnych do osiągnięcia celu badania.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in Eczema Area and Severity Index (EASI) score Week 6 / End of Treatment (EOT) Visit
    Modyfikacja stanu wyjściowego okolicy chorobowo zmienionej oraz ilość punktów Severity Index (EASI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6 / End of Treatment (EOT) Visit
    szósty tygodzień terapii / wizyta kończąca leczenie (EOT)
    E.5.2Secondary end point(s)
    1. Percentage of patients with ≥ 60% improvement on EASI total score Week 6 / End of Treatment (EOT) Visit.
    2. Change in grading of AD as defined by the scoring system of Rajka and Langeland from baseline as measured at Week 6 / End of Treatment (EOT) Visit.
    3. Percentage of body surface area affected (% BSA affected) at Week 6 / End of Treatment (EOT) Visit
    4. Physician’s Assessment of Individual Signs of Atopic Dermatitis at Week 6 / End of Treatment (EOT) Visit 5. Patient’s Assessment of Pruritus at week 6/ End of Treatment (EOT) Visit
    1. Procent pacjentów z ponad sześćdziesięcioprocentową poprawą według punktacji EASI
    2. Zmiana postaci AZS w porównaniu do wartości początkowej według systemu klasyfikacji Rajki i Langelanda
    3. Procent zajęcia ciała przez zmiany chorobowe (%BSA)
    4. Indywidualna ocena objawów AZS przeprowadzona przez lekarza
    5. Indywidualna ocena świądu przeprowadzona przez pacjenta
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 6 / End of Treatment (EOT) Visit
    w szóstym tygodniu leczenia / wizyta kończąca leczenie (EOT)
    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 No
    E.6.8Bioequivalence Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned13
    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 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
    India
    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
    LPLV
    ostatnia wizyta ostatniego pacjenta
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    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: 600
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 2012-04-17. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state195
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 195
    F.4.2.2In the whole clinical trial 650
    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)
    This is provided in the study protocol.
    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 Decision2012-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-28
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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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