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    Summary
    EudraCT Number:2022-003285-20
    Sponsor's Protocol Code Number:030(Z)MD22061
    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:2023-04-12
    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 number2022-003285-20
    A.3Full title of the trial
    Phase IV study comparing the efficacy and safety of an alcohol-free formulation of 0.15% benzydamine hydrochloride spray and benzydamine hydrochloride 3mg lozenges in paediatric patients (6-12 years) with sore throat.
    Изпитване фаза IV, сравняващо ефикасността и безопасността на формулировка без алкохол на бензидаминов хидрохлорид 0,15% спрей и бензидаминов хидрохлорид 3 mg таблетки за смучене при педиатрични пациенти (6-12 години) с възпалено гърло.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study comparing the effects of two different dosage forms (mouth spray and lozenges) of the same medication (benzydamine) in children aged 6-12 years with sore throat.
    Изпитване, сравняващо ефектите на две различни лекарствени форми (спрей за уста и таблетки за смучене) на едно и също лекарство (бензидамин) при деца на възраст 6-12 години с възпалено гърло.
    A.3.2Name or abbreviated title of the trial where available
    BeChild (Benzydamine in Child for Sore throat pain relief)
    BeChild (Бензидамин при деца за облекчаване на болки в гърлото).
    A.4.1Sponsor's protocol code number030(Z)MD22061
    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 SponsorAngelini Pharma S.p.A.
    B.1.3.4CountryItaly
    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 supportAngelini Pharma S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAngelini Pharma S.p.A.
    B.5.2Functional name of contact pointStudy Manager
    B.5.3 Address:
    B.5.3.1Street AddressViale Amelia 70
    B.5.3.2Town/ cityRome
    B.5.3.3Post code00181
    B.5.3.4CountryItaly
    B.5.4Telephone number00393472274815
    B.5.6E-mailmartina.barcaroli@angelinipharma.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 Yes
    D.2.1.1.1Trade name Tantum Verde 0,15% oromucosal spray, solution
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Pharma S.p.A., Viale Amelia 70, 00181, Rome, Italy
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTantum Verde 0,15% oromucosal spray, solution
    D.3.4Pharmaceutical form Oromucosal spray, solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    Oromucosal use
    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 Tantum Verde P 3mg lozenges mint flavor
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTantum Verde P 3mg lozenges mint flavor
    D.3.4Pharmaceutical form Lozenge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    Oromucosal use
    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
    acute sore throat
    Остро възпаление на гърлото
    E.1.1.1Medical condition in easily understood language
    acute sore throat
    Остро възпаление на гърлото
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10041367
    E.1.2Term Sore throat
    E.1.2System Organ Class 100000004855
    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 assess the local analgesic effect of benzydamine hydrochloride (spray or lozenges) in reducing sore throat pain at T15 min after a single dose administration to paediatric patients.
    Основната цел е да се оцени локалният аналгетичен ефект на бензидаминов хидрохлорид (спрей или таблетки за смучене) за намаляване на болката в гърлото при времева точка Т15 минути след приложение на единична доза при педиатрични пациенти.
    E.2.2Secondary objectives of the trial
    -To assess the local analgesic effect in reducing sore throat pain at T5 min, T10 min, T30 min and T45 min, after a single-dose administration of benzydamine hydrochloride spray or lozenges.
    -To assess the local analgesic effect in reducing sore throat pain, after 3 and 7 days of treatment, after a multiple-dose administration of benzydamine hydrochloride spray or lozenges.
    -To assess the safety and the tolerability of benzydamine hydrochloride spray or lozenges by collecting treatment-emergent adverse events (TEAEs), frequency, serious AEs, occurrence, changes in vital signs, in physical examination and in clinical symptoms after a single and repeated doses (up to a maximum of 7 days) of a topically administered benzydamine hydrochloride 0.15% spray in comparison with benzydamine hydrochloride lozenges 3mg.

    -За оценка на локалния аналгетичен ефект при намаляване на болката от възпалено гърло при T5 мин, T10 мин, T30 мин и T45 мин, след прилагане на единична доза бензидаминов хидрохлорид спрей или таблетки за смучене.
    -За оценка на локалния аналгетичен ефект за облекчаване на болката при възпаленото гърло, след 3 и 7 дни лечение, след многократно приложение на бензидаминов хидрохлорид спрей или таблетки за смучене.
    --За оценка на безопасността и поносимостта на бензидаминов хидрохлорид спрей или таблетки за смучене чрез събиране на информация за нежелани реакции, възникващи по време на лечението (TEAEs), честота, сериозни нежелани реакции, поява, промени в жизнените показатели, при физически преглед и клинични симптоми след еднократни и многократни дози (до максимум 7 дни) на локално приложен бензидаминов хидрохлорид 0,15% спрей в сравнение с таблетки за смучене бензидаминов хидрохлорид 3 mg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients (aged 6-12 years, limits included);
    2. Recent onset (≤3 days) of sore throat;
    3. Diagnosis of tonsillopharyngitis confirmed by a score ≥5 on TPA;
    4. A score of at least two points (equal to 1 face) in the WBS score;
    5. Signed and dated written Informed Consent: The ICF for participation in the study and consent to data processing will be signed by the parents/legal guardian while the child will sign the assent form only.

    1.Участници от мъжки и женски пол (на възраст 6-12 години, включително)
    2.Скорошна поява (≤3 дни) на възпалено гърло
    3.Диагноза тонзилофарингит, потвърдена с резултат ≥5 на TPA скала
    4. Резултат от най-малко две точки (равно на 1 лице) в резултата на WBS скала
    5.Подписано и датирано писмено информирано съгласие. Съгласието за участие в изпитването и съгласие за обработка на данни ще бъде подписано от родителите/законния настойник докато детето ще подпише само форма за съгласие.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to benzydamine hydrochloride or its excipients;
    2. Phenylketonuria;
    3. Clinically significant abnormalities at physical examination based on Investigator’s judgement;
    4. Intolerance to acetylsalicylic acid or other NSAIDS;
    5. History or diagnosis of asthma;
    6. Any concomitant disease that compromise breathing (i.e. bronchopneumonia);
    7. Severe coughing which causes throat discomfort (Investigator judgement);
    8. Purulent plaques on the tonsils;
    9. Any inhaled therapy in the previous week before the first IMP administration;
    10.Use of antibiotics for an acute disease in the 7 days before randomization; any sustained release analgesic within 24 hours of IMP administration; any medications for cold and flu (i.e., decongestants, antihistamines, expectorants, antitussives), immediate release analgesic or antipyretic within 4 hours of IMP administration;
    11.Use of any lozenge, mouthwash, spray or menthol-containing products within 2 hours prior to IMP administration;
    12.Participation to a clinical trial within 3 months prior to the inclusion in the
    study;
    13.Parents/legal guardian, who are unable to comprehend the full nature and
    purpose of the study and to comply with the requirements of the study;
    14.SARS-CoV2 positivity;
    15.Female patients of child-bearing potential, who are pregnant;
    16. Any other diseases that present sore throat as concomitant symptoms.

    1. Известна свръхчувствителност към бензидаминов хидрохлорид или неговите помощни вещества;
    2. Фенилкетонурия;
    3. Клинично значими аномалии при физикален преглед въз основа на преценка на лекаря-изследовател;
    4. Непоносимост към ацетилсалицилова киселина или други НСПВС;
    5. Анамнеза или диагноза астма;
    6. Всяко съпътстващо заболяване, което компрометира дишането (напр. бронхопневмония);
    7. Силна кашлица, която причинява дискомфорт в гърлото (преценка на лекаря-изследовател);
    8. Гнойни налепи по сливиците;
    9. Всяка инхалаторна терапия през предходната седмица преди първото приложение на изпитваното лекарство
    10. Използване на антибиотици при остро заболяване в 7-те дни преди рандомизацията; всеки аналгетик с продължително освобождаване в рамките на 24 часа преди приложението на изпитваното лекарство; всякакви лекарства за настинка и грип (напр. деконгестанти, антихистамини, отхрачващи средства, антитусиви), аналгетик или антипиретик с незабавно освобождаване в рамките на 4 часа след приложението на изпитваното лекарство;
    11. Използване на таблетки за смучене, вода за уста, спрей или продукти, съдържащи ментол, в рамките на 2 часа преди прилагане на изпитваното лекарство;
    12. Участие в клинично изпитване в рамките на 3 месеца преди включването в изпитването;
    13. Родители/законен настойник, които не са в състояние да разберат пълния характер и цел на изпитването и да се съобразят с изискванията на изпитването
    14. Положителен тест за SARS-CoV2;
    15. Участници във фертилна възраст, бременни;
    16. Всякакви други заболявания, които се характеризират с възпалено гърло като съпътстващи симптоми.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of responders defined as patients reporting a reduction of at least one face (equal to 2 points) in the WBS score (Wong-Baker Faces Pain Rating Scale) at T15 min after the first application of benzydamine hydrochloride 0.15% spray or benzydamine hydrochloride 3mg lozenges vs baseline.
    The WBS uses 6 different faces from smile to crying to describe the pain intensity of children aged 3 and above, from no hurt (0 point) to hurts worst (10 point), with a 2-point interval.
    Процент на участниците с положителен ефект, дефинирани като участници, съобщаващи за намаляване на болката с поне едно лице (равно на 2 точки) в резултата на WBS (скала за оценка на болката на Wong-Baker) при точка T15 мин. след първото приложение на бензидаминов хидрохлорид 0,15% спрей или бензидаминов хидрохлорид 3 mg таблетки за смучене спрямо първоначалните данни (изходното ниво). WBS използва 6 различни лица от усмивка до плач, за да опише интензитета на болката при деца на 3 и повече години, от липса на болка (0 точки) до най-силна болка (10 точки), с интервал от 2 точки
    E.5.1.1Timepoint(s) of evaluation of this end point
    T15 min after the first application of benzydamine hydrochloride 0.15% spray or benzydamine hydrochloride 3mg lozenges.
    Точка Т15 минути след първото приложение на бензидаминов хидрохлорид 0,15%
    спрей или бензидаминов хидрохлорид 3 mg таблетки за смучене.
    E.5.2Secondary end point(s)
    • Percentage of patients reporting a reduction of at least one face (equal to two points) in the WBS score vs baseline at T5 min, T10 min, T30 min, T45 min after a single dose administration.
    • Percentage of patients with sore throat disappearance, defined as WBS score equal to 0, and percentage of patients reporting a reduction of the WBS score of 2 points (equal to 1 face) vs baseline evaluated at full 3 and/or 7 days after multiple dosing.
    • Evaluation of the frequency of AEs/serious AEs, changes in vital signs, in physical examination and in clinical symptoms vs baseline after a single and repeated doses (up to a maximum of 7 days) of a topically administered benzydamine hydrochloride 0.15% spray in comparison with benzydamine hydrochloride lozenges 3mg.
    • The treatment effect in reducing sore throat intensity through a TPA scale at V1, V2 and/or V3/ETTV.
    - Процент на участниците, съобщаващи за намаляване на поне едно лице (равно на две точки) в резултата на WBS спрямо изходното ниво при точка T5 мин, T10 мин, T30 мин, T45 мин след приложение на единична доза.
    - Процент участници с отшумяване на симптомите на възпалено гърло, дефиниран като WBS резултат, равен на 0, и процент учаснтици, съобщаващи за намаление на WBS резултата от 2 точки (равно на 1 лице) спрямо изходното ниво, оценено на пълни 3 и/или 7 дни след многократно дозиране.
    - Оценка на честотата на нежеланите реакции/сериозните нежелани реакции, промените в жизнените показатели, при физикалния преглед и в клиничните симптоми спрямо изходното ниво след еднократни и многократни дози (до максимум 7 дни) на локално приложен бензидаминов хидрохлорид 0,15% спрей в сравнение с бензидаминов хидрохлорид таблетки за смучене 3 мг.
    - Лечебният ефект при намаляване на интензивността на възпаленото гърло чрез TPA при Посещение 1, Посещение 2 и/или на Посещение 3/Посещение за ранно прекратяване
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Reduction of pain at T5 min, T10 min, T30 min, T45 min after a single dose administration.
    -Disappearance of sore throat pain at 3 and/or 7 days after multiple dosing.
    -Reduction of the WBS score at day 3 and/or 7
    -evaluation and frequency of AEs changes in vital signs, and in physical examination and in clinical symptoms vs baseline after a single and repeated doses (up to a maximum of 7 days)
    -The treatment effect after 3 and/or 7 days treatment
    -Намаляване на болката при T5 мин, T10 мин, T30 мин, T45 мин след еднократно
    прилагане на дозата.
    -Изчезване на болки в гърлото на 3 ден и/или 7 дни след многократно дозиране.
    -Намаляване на WBS резултата на ден 3 и/или 7
    -оценка и честота на нежеланите реакции, промени в жизнените показатели и физическите
    преглед и при клинични симптоми спрямо изходното ниво след единична и
    многократни дози (до максимум 7 дни)
    - Ефект от лечението след 3 и/или 7 дни лечение
    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 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 Yes
    E.8.1.3Single blind No
    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.8.2.4Number 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 years1
    E.8.9.1In the Member State concerned months0
    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 months0
    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 Yes
    F.1.1Number of subjects for this age range: 356
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 300
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 56
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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
    Children aged 6 to 12 years old
    Деца от 6 до 12 години
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 356
    F.4.2.2In the whole clinical trial 356
    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
    не
    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 Decision2023-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-18
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