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    Summary
    EudraCT Number:2018-002913-37
    Sponsor's Protocol Code Number:MPN-001-07-2018
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-12-28
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2018-002913-37
    A.3Full title of the trial
    Multicenter, prospective, randomized, double-blind, two-armed phase IV clinical study for efficacy and safety assessment of two 2% mupirocin containing nasal ointments (MupiroNasal 20mg/g, nasal ointment, Antibiotic-Razgrad AD, Bulgaria as test product and Bactroban 2%, nasal ointment, GlaxoSmithKline, United Kingdom as reference product), applied to the anterior nares in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus).
    Многоцентрово, проспективно, рандомизирано, двойно-сляпо, с две рамена, IV-та фаза клинично изпитване за оценка на ефикасността и безопасността на две 2%-ви мупироцин-съдържащи мази за нос (MupiroNasal 20mg/g, маз за нос, Антибиотик-Разград АД, България като тест продукт и Bactroban 2%, маз за нос, GlaxoSmithKline, Обединеното Кралство като референтен продукт), приложени в предната част на ноздрите при здрави участници с назално носителство на Staphylococcus aureus (S. aureus).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study comparing the action and the safety of two approved drugs for nasal application,containing the same active substance - mupirocin.
    Клинично изпитване, сравняващо действието и безопасността на две разрешени за употреба лекарства за приложение в носа, съдържащи една и съща активна съставка - мупироцин.
    A.4.1Sponsor's protocol code numberMPN-001-07-2018
    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 SponsorAntibiotic-Razgrad AD
    B.1.3.4CountryBulgaria
    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 supportAntibiotic-Razgrad AD
    B.4.2CountryBulgaria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAntibiotic-Razgrad AD
    B.5.2Functional name of contact pointMedical and Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street Address81B Bulgaria blvd., office 10
    B.5.3.2Town/ citySofia
    B.5.3.3Post code1404
    B.5.3.4CountryBulgaria
    B.5.4Telephone number+359897967097
    B.5.6E-mailbhodzhova@antibiotic.bg
    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 Yes
    D.2.1.1.1Trade name MupiroNasal 20mg/g, nasal ointment
    D.2.1.1.2Name of the Marketing Authorisation holderAntibiotic-Razgrad AD
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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.3.4Pharmaceutical form Nasal ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMupirocin
    D.3.9.1CAS number 8000026-92-8
    D.3.9.3Other descriptive nameMUPIROCIN CALCIUM
    D.3.9.4EV Substance CodeSUB14612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Bactroban 2%, nasal ointment
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Nasal ointment
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMupirocin
    D.3.9.1CAS number 8000026-92-8
    D.3.9.3Other descriptive nameMUPIROCIN CALCIUM
    D.3.9.4EV Substance CodeSUB14612MIG
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    For elimination/eradication of nasal carriage of staphylococci, including methicillin-resistant Staphylococcus aureus (MRSA)
    За елиминиране/ликвидиране на назално носителство на стафилококи, включително метицилин-резистентен Staphylococcus aureus (MRSA)
    E.1.1.1Medical condition in easily understood language
    Asymptomatic presence of Staphylococcus aureus bacteria in the nose in clinically healthy people.
    Безсимптомно наличие на бактерии Staphylococcus aureus в носа при клинично здрави лица.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    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 the efficacy of MupiroNasal 2% nasal ointment in healthy subjects with nasal carriage of Staphylococcus aureus (S. aureus).
    - To compare the efficacy of MupiroNasal 2% nasal ointment with respect to the Reference medicinal product.
    - Да се оцени ефикасността на MupiroNasal 2% маз за нос при здрави индивиди с назално носителство на Staphylococcus aureus (S. aureus).
    - Да се сравнете ефикасността на MupiroNasal 2% маз за нос по отношение на Референтния лекарствен продукт.
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of the investigated medicinal product MupiroNasal 2% nasal ointment.
    - To compare the safety of MupiroNasal 2% nasal ointment with respect to the Reference medicinal product.
    - Да се оцени безопасността на изпитвания лекарствен продукт MupiroNasal 2% маз за нос.
    - Да се сравни безопасността на MupiroNasal 2% маз за нос по отношение на референтния лекарствен продукт.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subject between 18 to 75 years inclusive;
    • Judged clinically healthy from a medical history and medical examination (vital signs, axillary body temperature);
    • Clinical-laboratory examinations within the reference ranges or with no clinically significant abnormalities;
    • Negative pregnancy test for the women with reproductive potential;
    • Reliable and acceptable method of contraception for the women of child-bearing potential:
    • Asymptomatic S. aureus carriage has been established in two sequential microbiological swabs in both right and left anterior nares;
    • Treatment area amenable to topical treatment, i.e. anterior nares should be free of any obstructions and tissue damage.
    • In the investigator’s opinion, the subject is capable of giving informed consent;
    • In the investigator’s opinion, the subject is able to understand, willing and likely to fully comply with study procedures and restrictions;
    • The subject is able to attend all visits, complete the study, and comply with the necessary restrictions.
    • Участник от мъжки или женски пол на възраст между 18 и 75 години включително;
    • Оценен като клинично здрав на и базата на анамнезата и медицински преглед (витални показатели, аксиларна телесна температура);
    • Клинико-лабораторни показатели в референтни граници или без клинично значими отклонения в резултатите;
    • Отрицателен тест за бременност при жените с репродуктивен потенциал;
    • Надежден и приемлив метод за контрацепция при жените с детероден потенциал;
    • Асимптоматично носителство на S. aureus установено в две последователни микробиологични проби както в дясната така и в лявата ноздра;
    • Зоната на обработка да е достъпна за локална терапия, т.е. предната част на носа трябва да няма обструкции или увреждане на тъканите.
    • По преценка на изследователя, участникът е в състояние да даде информирано съгласие;
    • По преценка на изследователя, участникът е в състояние да разбере, желае и е вероятно да спазва напълно процедурите и ограниченията на изпитването;
    • Участникът е в състояние да участва във всички визити, да завърши изпитването и да изпълнява необходимите ограничения.
    E.4Principal exclusion criteria
    • Subjects with any physical or behavioral disorder, which, in the opinion of the Investigator, may interfere with the correct therapy with the IMPs or compliance with the Study Protocol requirements;
    • Subjects demonstrating any symptoms or sign of active infections or abnormality that may affect the microbiology tests or the treatment:
    - wound lesions and/or infections in the treated area and/or the skin or the soft tissues;
    - has active hay fever, on-going cold/flu symptoms, or a clinically significant history or currently active rhinitis;
    - has any structural abnormalities of the nose or nasal piercings;
    • Any clinically significant allergy, including known allergy to mupirocin or any of the excipients or known drug intolerance;
    • Use of concomitant medication, such as:
    - use of systemic or topical antibiotics (including mupirocin) or systemic treatment with immunosuppressive drugs e.g. cyclosporine, azathioprine or oral corticosteroids within 4 weeks prior to Day 0;
    - use of any prescribed medication in the 2 weeks prior to Day 0;
    - use of any non-prescribed medication (including herbal remedies, nutritional supplements or vitamins and minerals) in the 1 week prior to Day 0;
    - participation in a clinical study where the final dose of a New Chemical Entity occurred within the previous 16 weeks to Day 0;
    - participation in a clinical study where the final dose of a marketed drug occurred within the previous 12 weeks or at least 5 half-lives (whichever is longest) of Day 0.
    • Subjects suffering from or with a history for systemic diseases or alterations, such as: haematological, dermatological, renal, hepatic, endocrine, pulmonary, gastrointestinal, cardiovascular, respiratory, psychiatric, neurological disease;
    • Subjects, suffering from or who have history of immune system disorders, such as autoimmune diseases, HIV positive status, history of immune system degradation or recurrent herpes simplex or who are undergoing treatment with immunosuppressors or immunotherapy;
    • Subjects who suffer from another medical condition or who are receiving medication that in the Principal Investigator’s judgment would prohibit inclusion in the study;
    • History of known alcohol or substance abuse;
    • Refusal to sign the Informed Consent Form.
    • Участник с физическо или поведенческо разстройство, което по преценка на изследователя, би могло да попречи на правилното провеждане на терапията с Изпитваните лекарствени продукти или на спазването на изискванията на Протокола на изпитването;
    • Участникът демонстрира симптоми или белези на активна инфекция или отклонение, което може да повлияе на микробиологичните изследвания или на терапията:
    - рани и/или инфекции в зоната на обработка и/или кожата или меките тъкани;
    - активна сенна хрема, текущи симптоми на настинка/грип или клинично значима анамнеза или настоящ ринит;
    - наличие на структурна аномалия на носа или носен пиерсинг;
    • Наличие на клинично значими алергии, включително известна алергия към мупироцин или някоя от помощните съставки или известна непоносимост към лекарства;
    • Употреба на съпътстваща медикация, като например:
    - употреба на системни или локални антибиотици (включително мупироцин) или системна терапия с имуносупресивни лекарства, напр. циклоспорин, азатиоприн или орални кортикостероиди през последните 4 седмици преди Ден 0;
    - употреба на лекарства по рецепта през последните 2 седмици преди Ден 0;
    - употреба на лекарства без рецепта (вкл. билкови средства, хранителни добавки или витамини и минерали) през последната 1 седмица преди Ден 0;
    - участие в клинични изпитвания, при които последната доза от ново химическо лекарство е била през последните 16 седмици преди Ден 0;
    - участие в клинични изпитвания, при които последната доза от разрешено за употреба лекарство е била през последните 12 седмици или поне 5 полуживота (който от двата периода е по-дълъг) от Ден 0;
    • Участник, страдащ от или с анамнеза за системни заболявания или отклонения, като: хематологични, дерматологични, бъбречни, чернодробни, ендокринни, белодробни, гастроинтестинални, кардиоваскуларни, респираторни, психиатрични, неврологични заболявания;
    • Участник, страдащ от или с анамнеза за имунни системни нарушения, като автоимунни заболявания, HIV позитивен статус, анамнеза за системно понижение на имунната система или често повтарящ се Херпес симплекс или такива, които в момента са подложени на терапия с имуносупресори или имунотерапия;
    • Участник, страдащ от друго медицинско състояние или приема лекарства, които по преценка на Главния изследовател, би възпрепятствало включването му в изпитването;
    • Анамнеза за злоупотреба с алкохол или забранени вещества;
    • Отказ от подписване на Информираното Съгласие.
    E.5 End points
    E.5.1Primary end point(s)
    Apparent Eradication of Nasal Carriage of Staphylococcus aureus, including MRSA.
    Очевидно ерадикация на носното носителство на Staphylococcus aureus, включително MRSA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The efficacy evaluation will be performed after the end of the full treatment period (5 days).
    Оценката на ефикасността ще се извърши след края на пълния курс на лечение (5 дни).
    E.5.2Secondary end point(s)
    The Number of Subjects With Adverse Events and Changes in Vital Signs and Routine Haematology, Clinical Chemistry and Urinalysis Tests Assessed Over the Five Day Treatment Period and Follow-up 5 days after the end of the treatment.
    Броят на участници с нежелани събития и промени във виталните показатели и рутинните лабораторни тестове (хематологични, биохимични и уринни тестовете), оценени през петдневния период на третиране и последващия контролен период от 5 дни след края на лечението.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The follow-up of the safety parameters is during the entire treatment period and 5 days after the end of the therapy.
    Проследяването на безопасността е през целия период на третиране и 5 сни след края на терапията.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    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 concerned4
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    ПППУ
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state260
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 260
    F.4.2.2In the whole clinical trial 260
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Няма
    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 Decision2019-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-13
    P. End of Trial
    P.End of Trial StatusCompleted
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