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    Summary
    EudraCT Number:2015-004782-92
    Sponsor's Protocol Code Number:NAB-BC-3781-3102
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-06-07
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-004782-92
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Oral Lefamulin (BC-3781) Versus Oral Moxifloxacin in Adults With Community-Acquired Bacterial Pneumonia
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bacterial Pneumonia treatment with a new antibiotic compared to an existing one.
    A.4.1Sponsor's protocol code numberNAB-BC-3781-3102
    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 SponsorNabriva Therapeutics AG
    B.1.3.4CountryAustria
    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 supportNabriva Therapeutics AG
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNabriva Therapeutics AG
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressLeberstraße 20
    B.5.3.2Town/ city Vienna
    B.5.3.3Post code1110
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1 74093 1242
    B.5.5Fax number+43 1 74093-1900
    B.5.6E-mailclaudia.lell@nabriva.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 namelefamulin
    D.3.2Product code BC-3781
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLefamulin
    D.3.9.1CAS number 1061337-51-6
    D.3.9.2Current sponsor codeBC-3781
    D.3.9.3Other descriptive nameLefamulin
    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 Yes
    D.3.11.13.1Other medicinal product typeA semi-synthetic antimicrobial agent. Starting material (pleuromutilin) is a fermented product, which is subsequently purified and chemically modified (4 synthetic steps) to yield lefamulin.
    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 Avelox 400 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBayer plc, Bayer House, Strawberry Hill, Newbury,Berkshire RG14 1JA
    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 nameAvelox
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMoxifloxacin
    D.3.9.1CAS number 186826-86-8
    D.3.9.3Other descriptive nameAvelox
    D.3.9.4EV Substance CodeSUB09086MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Community-acquired bacterial pneumonia (CABP) is a commonly occurring serious infection that requires systemic antibiotic therapy and is associated with substantial morbidity, mortality, and considerable healthcare costs.It is the leading cause of death from infectious diseases
    E.1.1.1Medical condition in easily understood language
    Community-acquired bacterial pneumonia (CABP) is a commonly occurring serious infection that requires systemic antibiotic therapy
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objectives
    • Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent-to-Treat (ITT) Analysis Set (FDA endpoint).
    • Demonstrate the NI of lefamulin versus comparator with respect to the Investigator’s Assessment of Clinical Response at Test of Cure (TOC) (i.e., 5-10 days after the last dose of study drug) in the modified-ITT (mITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets (EMA endpoint).
    E.2.2Secondary objectives of the trial
    Secondary Objectives
    • Evaluate the Early Clinical Response in the Microbiological Intent-to-Treat (microITT) Analysis Set.
    • Evaluate the Investigator’s Assessment of Clinical Response at TOC in the microITT and Microbiologically Evaluable at TOC (ME-TOC) Analysis Sets.
    • Evaluate the By-Pathogen Microbiologic Response at TOC in the microITT and ME-TOC Analysis Sets.
    • Evaluate the safety and tolerability of lefamulin versus comparator in the Safety Analysis Set.
    • Evaluate 28 day all-cause mortality in the ITT Analysis Set.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be male or female ≥ 18 years of age.
    2. Provide written informed consent and be willing and able to adhere to the study-specified procedures and restrictions. NOTE: Consent may be provided by the subject’s legally authorized representative in accordance with local regulations.
    3. Have an acute illness (≤ 7 days duration) with at least 3 of the following symptoms consistent with a lower respiratory tract infection (new or worsening):
    • Dyspnea.
    • New or increased cough.
    • Purulent sputum production.
    • Chest pain due to pneumonia.
    4. Have at least 2 of the following vital sign abnormalities:
    • Fever (body temperature > 38.0 °C (100.4 °F) measured orally or equivalent temperature from an alternate body site) or hypothermia (body temperature < 35.0 °C (95.0 °F) measured orally or equivalent temperature from an alternate body site).
    • Hypotension (systolic blood pressure < 90 mmHg).
    • Tachycardia (heart rate > 100 beats/min).
    • Tachypnea (respiratory rate > 20 breaths/min).
    5. Have at least 1 other clinical sign or laboratory finding of CABP:
    • Hypoxemia (i.e., O2 saturation < 90 % on room air or while receiving supplemental oxygen at subject’s baseline requirement or PaO2 < 60 mmHg).
    • Auscultatory and/or percussion findings consistent with pneumonia (e.g., crackles, egophony, dullness).
    • White blood cell (WBC) count > 10 000 cells/mm3 or < 4 500 cells/mm3 or > 15 % immature neutrophils (bands) regardless of total WBC count.
    6. Have radiographically-documented pneumonia within 48 hours before enrollment (i.e., infiltrates in a lobar or multilobar distribution or diffuse opacities on chest x-ray consistent with acute bacterial pneumonia). NOTE: if a chest computed tomography scan
    has been performed within 48 hours of enrollment and demonstrates findings consistent with pneumonia, it can be used in place of a chest x-ray.
    7. Have a Pneumonia Outcomes Research Team (PORT) Risk Class of II, III, or IV and be an appropriate candidate for oral antibiotic therapy as treatment for the current episode of CABP.
    8. If female, meets the following criteria:
    • Surgically sterile or ≥ 2 years postmenopausal, or if of childbearing potential (including being < 2 years postmenopausal), has a negative pregnancy test, and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception (e.g., condom plus diaphragm, condom plus spermicide, intrauterine device plus spermicide) during the study and for ≥ 28 days after the last dose of study drug. If a male partner has been surgically sterile for ≥ 1 year, a single contraception method may be used. NOTE: The use of contraceptives containing progesterone is not permitted.
    Agrees not to breastfeed during the study and through ≥ 28 days after the last dose of study drug.
    9. If male, meets the following criteria:
    • If not surgically sterile and if participating in sexual activity that may lead to pregnancy, agrees to use an effective dual method of contraception (e.g., condom plus diaphragm, condom plus spermicide, intrauterine device plus spermicide, oral contraceptive plus condom) during the study and through ≥ 28 days after the last dose of study drug. If surgically sterile for ≥ 1 year, a single contraception method may be used.
    E.4Principal exclusion criteria
    1. Have received more than a single dose of a short-acting oral or IV antibacterial for CABP within 72 hours before randomization 2. Require concomitant systemic antibacterial therapy potentially effective against CABP pathogens
    3. Have been hospitalized for 2 or more days within 90 days prior to the onset of symptoms or have resided in a nursing home or long-term healthcare facility within 30 days prior to the onset of symptoms.
    4. Have confirmed or suspected CABP caused by a pathogen known to be resistant to any of
    the study drugs (e.g., MRSA, Pseudomonas aeruginosa, any pathogen of the
    Enterobacteriaceae Family) or attributable to etiologies other than community-acquired bacterial pathogens (e.g., ventilator-associated pneumonia, hospital-acquired bacterial pneumonia, bacterial aspiration pneumonia, Pneumocystis jiroveci pneumonia or other
    fungal pneumonia, viral or mycobacterial infection of the lung).
    5. Have a noninfectious cause of pulmonary infiltrates (e.g., pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure, bronchial obstruction, lung cancer, cystic fibrosis).
    6. Have confirmed or suspected pleural empyema (does not include sterile parapneumonic effusions).
    7. Have or be at risk for major cardiac events or dysfunction including, but not limited to, the following:
    • Known prolonged QT interval or family history of long QT syndrome
    • Clinically significant hypokalemia which has not been treated prior to randomization
    • Clinically unstable cardiac disease, including: unstable atrial fibrillation, symptomatic bradycardia, unstable congestive heart failure, active myocardial ischemia, or indwelling pacemaker
    • Complete left bundle branch block
    • Receipt within 7 days before enrollment of Class IA or Class III anti-arrhythmic medication or, in the opinion of the Investigator, subject may require such medication during the study. (Class 1A: Quinidine, Procainamide, Disopyramide; Class III: Amiodarone, Dofetilide, Ibutilide, Sotalol)
    • Receipt within 7 days before enrollment of medication that has the potential of prolonging the QT interval or, in the opinion of the Investigator, subject may require such medication during the study
    8. Be receiving a strong p-glycoprotein inhibitor or a strong CYP3A inducer or inhibitor
    9. Have a history of tendon disease/disorder, myasthenia gravis, or known or suspected central nervous system (CNS) disorders (severe cerebrovascular arteriosclerosis, epilepsy, or other risk factors that may predispose to seizures).
    10. Have a history of any hypersensitivity or allergic reaction to any fluoroquinolone, or any drug in the pleuromutilin class (i.e., retapamulin).
    11. Have severely impaired renal function, defined as estimated creatinine clearance (CrCl) ≤ 30 mL/min as calculated by the Cockcroft-Gault formula.
    12. Have evidence of significant hepatic, hematologic, or immunologic disease including any of the following:
    • Known acute hepatitis, including acute viral hepatitis.
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 5 times the upper limit of normal (ULN),
    • Total bilirubin > 3 times the ULN (unless known Gilbert’s disease).
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 3 times the upper limit of normal (ULN) and total bilirubin > 2 times the ULN.
    • History of cirrhosis of the liver.
    • Manifestation of end-stage liver disease, such as ascites or hepatic encephalopathy.
    • Current or anticipated neutropenia (< 500 neutrophils/mm3).
    • Thrombocytopenia (< 50 000 platelets/mm3).
    • Known infection with human immunodeficiency virus and a CD4 count < 200/mm3.
    13. Have known severe immunosuppression, including but not limited to receipt of corticosteroid therapy (≥20 mg of prednisone/day or equivalent for >4 weeks) within the previous 8 weeks; solid organ or bone marrow transplantation within the previous 12 months; or currently receiving cytotoxic chemotherapy.
    14. Have a life expectancy of ≤ 3 months because of any disease other than the current episode of CABP (e.g., current or impending respiratory failure, acute heart failure, shock, acute coronary syndrome, unstable arrhythmia, hypertensive emergency, clinically relevant gastrointestinal bleeding, profound metabolic abnormality, or acute cerebrovascular event).
    15. Have participated in any study involving administration of an investigational agent or device within 30 days or ≤ 5 terminal elimination half-lives of the previous investigational medicinal product, whichever is longer, before enrollment.
    16. Have been previously treated with lefamulin or previously enrolled in this study.
    17. Have 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)
    Demonstrate the non-inferiority (NI) of lefamulin versus comparator with respect to the Early Clinical Response (96 ± 24 hours after the first dose of study drug) in the Intent-to-Treat (ITT) Analysis Set (FDA endpoint).
    • Demonstrate the NI of lefamulin versus comparator with respect to the Investigator’s Assessment of Clinical Response at Test of Cure (TOC) (i.e., 5-10 days after the last dose of study drug) in the modified-ITT (mITT) and Clinically Evaluable at TOC (CE-TOC) Analysis Sets (EMA endpoint).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The EMA supports assessment of clinical response by Investigators at a test of cure (TOC) visit, while the FDA adopted assessment of clinical signs and symptoms of CABP on Days 3 to 5 as the recommended primary endpoint.
    FDA endpoint - 96 hours +/- 24 hours
    EMA endpoint - 2 days after the last dose of study drug
    E.5.2Secondary end point(s)
    Please use the following for secondary endpoints - the time of evaluation is in parentheses after the endpoint:
    Secondary Objectives
    - Evaluate the Early Clinical Response in the Microbiological Intent‑to‑Treat (microITT) Analysis Set. (96 ± 24 hours after the first dose of study drug)
    - Evaluate the Investigator’s Assessment of Clinical Response at TOC in the microITT and Microbiologically Evaluable at TOC (ME-TOC) Analysis Sets. (5-10 days after the last dose of study drug)
    - Evaluate the By-Pathogen Microbiologic Response at TOC in the microITT and ME-TOC Analysis Sets. (5-10 days after the last dose of study drug)
    -Evaluate the safety and tolerability of lefamulin versus comparator in the Safety Analysis Set.
    -Evaluate 28 day all-cause mortality in the ITT Analysis Set (Day 28)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Days 3 – 5, Day s 5 – 10 and Day 28
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    This multicenter, multinational, randomized, double-blind, double-dummy, active-controlled efficacy
    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 trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA81
    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
    Brazil
    Bulgaria
    Chile
    Georgia
    Hungary
    Korea, Republic of
    Latvia
    Mexico
    Peru
    Philippines
    Poland
    Romania
    Russian Federation
    Serbia
    South Africa
    Spain
    Taiwan
    Ukraine
    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
    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 months5
    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 months5
    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: 369
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 369
    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 2016-06-07. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 738
    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)
    standard of care as determined by the patient's physician
    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 Decision2016-07-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-01-02
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