Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-022487-12
    Sponsor's Protocol Code Number:CXL-MD-02
    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:2010-12-20
    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 number2010-022487-12
    A.3Full title of the trial
    A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus treatment with IV doripenem.


    A.4.1Sponsor's protocol code numberCXL-MD-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01281462
    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 SponsorCerexa, Inc
    B.1.3.4CountryUnited States
    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 supportForest Laboratories Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCerexa, Inc.
    B.5.2Functional name of contact pointDouglas Rank, MD
    B.5.3 Address:
    B.5.3.1Street Address2100 Franklin St. Suite 900
    B.5.3.2Town/ cityOakland
    B.5.3.3Post codeCA 94612, USA
    B.5.4Telephone number001510285-9280
    B.5.5Fax number001510285-9299
    B.5.6E-maildrank@cerexa.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 nameCeftaroline fosamil for injection
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.9.1CAS number 229016-73-3
    D.3.9.2Current sponsor codeceftaroline fosamil
    D.3.9.3Other descriptive namePPI-0903, TAK-599, ceftaroline acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameNXL104 for injection
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.9.1CAS number 1192491-61-4
    D.3.9.2Current sponsor codeNXL104
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP 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 Doribax 500 mg powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameDoribax 500 mg powder for solution for infusion
    D.3.4Pharmaceutical form Powder for solution for infusion
    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.3.8INN - Proposed INNDORIPENEM
    D.3.9.1CAS number 148016-81-3
    D.3.9.4EV Substance CodeSUB22196
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Complicated Urinary Tract Infection
    E.1.1.1Medical condition in easily understood language
    Complicated urinary tract infections including lower urinary tract infections with complicating factors in addition to acute pyelonephritis.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10054088
    E.1.2Term Urinary tract infection bacterial
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are to:
    • Determine the microbiological response in the Microbiologically Evaluable (ME) Population at Test-of-Cure
    (TOC).
    • Evaluate the safety of coadministered IV ceftaroline fosamil and NXL104 in subjects with cUTI.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study include:
    • Determine the clinical response in the Clinically Evaluable (CE) Population at TOC.
    • Determine the microbiological and clinical responses in the microbiological Intent-to-Treat (mITT) Population
    at TOC.
    • Evaluate microbiological and clinical responses at End of Therapy (EOT) and at Late Follow-up (LFU).
    • Evaluate microbiological and clinical responses at TOC in subjects with complicated lower urinary tract
    infection (cLUTI) or acute pyelonephritis (AP).
    • Evaluate the pharmacokinetics of ceftaroline fosamil (prodrug), ceftaroline, ceftaroline M-1 (inactive
    metabolite), and NXL104 in subjects with cUTI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, at least 18 years of age.
    2. Have pyuria, defined as ≥ 10 white blood cells (WBCs) per mm3 in unspun urine or ≥ 10 WBCs per high
    power field in spun urine.
    3. A local urine Gram stain must demonstrate the presence of gram-negative bacilli.
    4. Clinical signs and/or symptoms of cUTI defined as:
    a. Acute pyelonephritis, as indicated by BOTH of the following:
    i. Fever ≥ 38.0ºC oral
    ii. Flank pain or costovertebral angle tenderness
    OR
    b. Complicated lower urinary tract infection, as indicated by at least one of the following symptoms AND at least
    one of the following complicating factors:
    i. Symptoms (at least one):
    • Dysuria
    • Frequency
    • Suprapubic pain
    • Urgency
    • Acute hematuria
    ii. Complicating factors (at least one):
    • Male gender
    • Current bladder instrumentation or indwelling urinary catheter (any tube, stent, or foreign body conduit that
    extends from the inside to the outside of the body) that is expected to be removed during the course of IV study
    drug administration
    • Obstructive uropathy (eg, nephrolithiasis, tumor, fibrosis) that is expected to be medically or surgically treated
    during the course of IV study drug administration
    • Urogenital surgery (eg, prostatectomy, transurethral resections) within 7 days prior to administration of the first
    dose of study drug
    • Functional or anatomical abnormality of the urogenital tract including anatomic
    malformations or neurogenic bladder, or with a postvoid residual urine volume of at least 100 mL
    5. Have a pretreatment baseline urine culture specimen obtained within 48 hours before start of administration of
    the first dose of study drug.
    NOTE: Subjects may be enrolled in this study and start IV study drug therapy before the Investigator knows
    the results of the baseline urine culture, but a local urine Gram stain must be performed and demonstrate the
    presence of gram-negative bacilli prior to start of study drug.
    6. The subject’s infection would require initial treatment with IV antibiotics.
    7. The subject must require initial hospitalization to manage the cUTI by the standard of care.
    8. Female subjects of child-bearing potential, including those who are fewer than 2 years post-menopausal,
    must agree to, and comply with, using 2 highly effective methods of birth control (ie, condom plus spermicide,
    combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a
    vasectomized partner) while participating in this study. In addition, all women of childbearing potential must
    agree to continue to use 2 forms of birth control throughout the study and for at least 30 days after administration
    of the last dose of study drug.
    9. Signed informed consent, willingness, and ability to comply with all study procedures and restrictions.
    E.4Principal exclusion criteria
    1. History of any hypersensitivity or allergic reaction to any β-lactam (eg, cephalosporins, penicillins,
    carbapenems).
    2. Requirement for concomitant systemic antibiotic or antifungal therapy for any reason.
    EXCEPTION: Topical antifungal or a single oral dose of any antifungal for treatment of vaginal candidiasis.
    3. Known urinary tract infection or colonization with Pseudomonas aeruginosa, methicillin-resistant
    Staphylococcus aureus, or any Enterococcus species.
    4. The cUTI is known to be caused by a pathogen resistant to doripenem.
    5. Confirmed fungal urinary tract infection with a colony count ≥ 103 CFU/mL.
    6. Receipt of any amount of potentially therapeutic antibiotic therapy after the collection of the pretreatment
    baseline urine culture and before administration of the first dose of study drug.
    7. Receipt of more than 1 dose of a potentially therapeutic antibiotic agent for the treatment of the current cUTI
    within 96 hours before obtaining the study-qualifying pretreatment baseline urine culture.
    EXCEPTIONS: 1) Subjects who failed prior antibiotic treatment with a culture growing a pathogen resistant to
    the prior treatment; 2) Subjects receiving UTI prophylaxis are eligible to enroll if all other eligibility criteria are
    met, including obtaining a study-qualifying pretreatment baseline urine culture. These subjects must discontinue
    oral antibiotic prophylaxis from the time the pretreatment baseline urine culture is obtained until after TOC.
    8. Intractable UTI anticipated to require more than 10 days of study drug therapy.
    9. Complete, permanent obstruction of the urinary tract.
    10. Permanent indwelling bladder catheter or instrumentation (including nephrostomy) or current urinary catheter
    that will not be removed during IV study drug administration.
    11. Suspected or confirmed perinephric or intrarenal abscess.
    12. Suspected or confirmed prostatitis.
    13. Ileal loops or vesico-ureteral reflux.
    14. Impairment of renal function including a calculated CrCl of < 30 mL/min, requirement for peritoneal dialysis,
    hemodialysis or hemofiltration, or oliguria (< 20 cc urine output per hour over 24 hours).
    15. Renal transplantation.
    16. Evidence of immediately life-threatening disease, including, but not limited to, current or impending
    respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive ketoacidosis), or acute cerebrovascular events.
    17. Life expectancy less than 3 months
    18. Evidence of significant hepatic, hematological, or immunologic disease or dysfunction determined by any of
    the following:
    • Known acute viral hepatitis
    • Aspartate amino transferase or alanine amino transferase level greater than 5-fold the upper limit of normal or
    total bilirubin greater than 3-fold the upper limit of normal
    • Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy
    • Current or anticipated neutropenia defined as less than 500 neutrophils/mm3
    • Thrombocytopenia with platelet count less than 60,000 cells/mm3
    • Known infection with human immunodeficiency virus and either a CD4 count less than or equal to 200 cells/
    mm3 at the last measurement or current diagnosis of another Acquired Immune Deficiency Syndrome-defining
    illness
    • Bone marrow-ablative chemotherapy or radiation therapy within the prior 3 months
    • Receiving > 20 mg of prednisone (or equivalent systemic corticosteroid) per day
    19. Probenecid administration within 3 days prior to initiation of study drug therapy or requirement for
    concomitant therapy with probenecid.
    20. Past or current history of epilepsy or seizure disorder.
    EXCEPTION: Well-documented febrile seizure of childhood.
    21. Women who are pregnant or nursing.
    22. Participation in any study involving administration of an investigational agent or device within 30 days prior
    to randomization into this study or previous participation in the current study.
    23. Previous participation in a study of ceftaroline fosamil, NXL104, ceftazidime/NXL104, or coadministered
    ceftaroline fosamil and NXL104
    24. Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the
    quality of the data
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint:
    Proportion of subjects with a favorable microbiological response in the ME Population at TOC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timing of the primary endpoint is TOC which occurs 5-11 days after the end of therapy. The study requires 7-10 days study drug administration. Therefore the timing of the primary endpoint is about 12-21 days after enrollment in the study. Note TOC could occur earlier if study drug is discontinued early.

    E.5.2Secondary end point(s)
    • Proportion of subjects with a clinical response of cure in the CE Population at TOC
    • Proportion of subjects with a favorable microbiological response in the mITT Population at TOC
    • Proportion of subjects with a clinical response of cure in the mITT Population at TOC
    • Proportion of subjects with a sustained favorable microbiological response in the ME Population at
    LFU
    • Proportion of subjects with a clinical response of sustained clinical cure in the CE Population at LFU
    • Proportion of subjects with a favorable microbiological response in the ME Population at TOC and the
    proportion of subjects with a clinical response of cure in the CE Population at TOC in subjects with
    cLUTI or AP
    • Per-pathogen outcome in the mITT and ME Populations at TOC
    • Proportion of subjects with a favorable microbiological response in the ME Population at EOT
    • Proportion of subjects with a clinical response of cure in the CE Population at EOT
    • Incidence of emergent infections
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints may occur at:
    End of Therapy (EOT) which occurs at the end of study drug administration and is 7-10 days after enrollment. Note, EOT could occur earlier if study drug is discontinued early.
    Test-of-cure (TOC) which is defined at E.5.1.1.
    Late Follow-up (LFU) which is 28-42 days after EOT therefore making this window 35-52 days after enrollment. Note LFU could occur earlier if study drug is discontinued early and EOT occurs earlier than 7-10 days after enrollment.

    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 No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Bulgaria
    Germany
    Lebanon
    Poland
    Russian Federation
    Turkey
    United States
    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 years1
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 No
    F.3.3.1Women of childbearing potential not using contraception Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    If a subject is unable to provide written informed consent, the subject’s legally acceptable representative may provide written consent, as approved according to institution-specific guidelines.

    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 215
    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)
    See 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 Decision2011-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-08-03
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA