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    Summary
    EudraCT Number:2018-002543-28
    Sponsor's Protocol Code Number:MIRA1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2019-10-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-002543-28
    A.3Full title of the trial
    A multi-center, randomized, placebo-controlled, double-blind, dose-finding clinical trial investigating the short-term relief of symptoms of acute pharyngitis such as throat soreness pain and difficulty to swallow by treatment with three different doses of MYRAMISTIN™ oromucosal spray
    Eine multizentrische, randomisierte , placebokontrollierte, doppelblinde Dosisfindungsstudie zur raschen Linderung von Symptomen einer akuten Pharyngitis wie Halsschmerzen und Schluckbeschwerden durch Behandlung mit drei unterschiedlichen Dosierungen MYRAMISTIN™ Spray zur Anwendung in der Mundhöhle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study investigating Myramistin versus Placebo for acute pharyngitis
    A.3.2Name or abbreviated title of the trial where available
    MIRA 1
    A.4.1Sponsor's protocol code numberMIRA1
    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 SponsorMEGAINPHARM GmbH
    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 supportMEGAINPHARM GmbH
    B.4.2CountryAustria
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMEGAINPHARM GmbH
    B.5.2Functional name of contact pointGeneral Manager
    B.5.3 Address:
    B.5.3.1Street AddressBoecklinstraße 50
    B.5.3.2Town/ cityWien
    B.5.3.3Post code1020
    B.5.3.4CountryAustria
    B.5.4Telephone number004315134733
    B.5.5Fax number00431513473330
    B.5.6E-mailevgorokhov@megainpharm.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 nameMyramistin 0.005%
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15809-19-5
    D.3.9.3Other descriptive nameMIRAMISTIN
    D.3.9.4EV Substance CodeSUB37032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,05
    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 nameMyramistin 0.01%
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15809-19-5
    D.3.9.3Other descriptive nameMIRAMISTIN
    D.3.9.4EV Substance CodeSUB37032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    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 nameMyramistin 0.02%
    D.3.4Pharmaceutical form Oromucosal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 15809-19-5
    D.3.9.3Other descriptive nameMIRAMISTIN
    D.3.9.4EV Substance CodeSUB37032
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0,2
    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 placeboOromucosal spray
    D.8.4Route of administration of the placeboOropharyngeal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acute Pharyngitis
    E.1.1.1Medical condition in easily understood language
    Acute inflammation of the back of the throat
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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 short-term efficacy of different MyramistinTM doses
    (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis.
    E.2.2Secondary objectives of the trial
    To evaluate the long-term efficacy, safety and tolerability of different MyramistinTM doses (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute pharyngitis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female at the ages of 18 to 75 years
    2. Body Mass Index (BMI): 18-31 kg/m2
    3. Willing and able to give informed consent
    4. Clinically diagnosed acute pharyngitis
    5. Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1
    6. Symptoms of acute pharyngitis such as sore throat and difficulty to swallow
    7. Sore throat pain intensity scored as at least 60 mm on a 0-100 mm VAS Sore Throat Pain Intensity Scale (STPIS)
    8. Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing Scale (DSS)
    9. Tonsillo-Pharyngitis Assessment (TPA) ≥ 6 on 21-point TPA- scale
    10. Absence of Streptococcus group A as confirmed by a rapid swab test before randomization
    11. Determination of McIsaac - Score (to exclude GAS pharyngitis)
    12. Willing to stay in the trial center for at least 2 hours (maximum 3 hrs) after the first dose and return after 72 hours treatment on Day 4
    13. Willing not to take anything by mouth excluding the trial medication and / or unable to abstain from smoking during the stay in the trial center. Drinking of water is allowed from 30 minutes after first application onwards.
    14. Female patients must have
    • either a negative pregnancy test at Visit 1 and practicing a reliable method of contraception used consistently and correctly (including oral contraceptives, hormone implant, intrauterine device), or
    • must be postmenopausal (no spontaneous menstrual periods for at least 12 months) or
    • must be surgically sterile (tubal ligation or removal of ovaries or uterus)
    E.4Principal exclusion criteria
    1. Patients with strong suspicion of Group A Streptococcus infection. Either swab test is positive OR McIsaac Score ≥3 points
    2. Presence of signs or symptoms of any acute infection for which treatment with antibiotics is mandatory and/or should not be postponed; i.e. accompanied fever (> 38°C at Visit 1) and/or - if visually identified pharyngeal - presence of seropurulent, purulent, fibro serous or fibrinous exudate from the pharyngeal mucosa
    3. Patients with allergies or bronchial asthma who have a history of exacerbations within 30 days prior to trial inclusion
    4. The use of any systemic analgesics / local analgesics in the throat area (e.g. Acetyl Salicylic Acid = ASA > 100 mg), during the trial or within 12 hours prior first study medication application. Exception Paracetamol: intake of Paracetamol is allowed up to 6 hours before first application of study medication
    5. The use of systemic antibiotics / local antibiotics in the throat area during the trial and within the previous 7 days prior to Visit 1
    6. The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to Visit 1
    7. The use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the throat area (e.g. non-steroidal anti-inflammatory drugs or glucocorticoids) during the trial or within 12 hours prior first study medication application
    8. The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first study medication application.
    9. The use of any other ‘sore throat medication’ (e.g. lozenges, drops, sprays, decongestants) or other ‘cold medication’ that could interfere the trial results within the previous 12 hours prior to first study medication application
    10. Major wounds of the mouth and throat
    11. Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
    12. Existing cardiac, haematological, hepatic, renal, gastrointestinal, metabolic and / or pathological findings, which might interfere with the drug’s safety, tolerability and / or absorption according to the judgement of the Investigator
    13. Any neurological or psychiatric conditions, which might give the impression that the patients will not comply with the protocol and trial needs
    14. Patients with history (previous 5 years) or present condition of any malignancy
    15. Known hypersensitivity to any ingredient of MyramistinTM and/or any contraindication against the rescue medication Paracetamol
    16. Previous participation in the trial
    17. Parallel participation in any other trial with an IMP during the previous 90 days before screening
    18. History of alcohol or drug abuse
    19. Known or suspected of being unable to comply with the clinical trial protocol (e.g. no permanent address, history of drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
    20. Legal incapacity and / or other circumstances rendering the patients unable to understand the nature, scope and possible impact of the trial
    21. Female patients meeting any of the following criteria will not be eligible:
    - Pregnant
    - Lactating
    22. Patients who are members of the staff of the trial centre, staff of the Sponsor or the clinical research organisations (CROs), the Investigator him-/ herself or close relatives of the Investigator
    E.5 End points
    E.5.1Primary end point(s)
    • The primary endpoint is SPID-2Pain, defined as pain intensity
    differences (PID) summarized over the time course of 2 hours after first application on Day 1 (Baseline). The sum is calculated over the timeweighted differences from each measured time point to Baseline after dosing using the 100mmVAS Sore Throat Pain Intensity Scale (STPIS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    timepoints summarized over the time course of 2 hours (10, 15, 20, 30, 45, 60, 75, 90, 105, and 120 mins)
    E.5.2Secondary end point(s)
    • SPID-2Swallow calculated analogously to the primary endpoint (including sensitivity analysis) using the Difficulty Swallowing Scale (DSS)
    • Over 1 Hour: SPID-1Pain and SPID-1Swallow analogously to SPID-2
    • Over 3 Hours: SPID-3Pain and SPID-3Swallow analogously to SPID-2
    • Throat Pain Intensity (PI) and Pain Intensity Differences from baseline (PID) separately for throat pain and difficulty in swallowing at each measured time point (after 10, 15, 20, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, and 180 minutes).
    • Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline
    • Time to 30% and 50% relief in difficulty in swallowing (30% and 50% reduction in DSS) compared to baseline
    • PI and PID for STPIS and DSS for Day 1 (evening rating), Day 2 and Day 3 (morning and evening rating) and Day 4 (morning rating)
    • Percentage of patients symptom free in throat pain at Visit 2 (STPIS=0).
    • Percentage of patients symptom free in difficulty in swallowing at Visit 2 (DSS=0)
    • Percentage of patients symptom free in throat pain and difficulty in swallowing at Visit 2 (STPIS=0 and DSS=0 – defined as complete response)
    • Change in Tonsillo-Pharyngitis Assessment (TPA) sum-score and single symptom scores from baseline to Visit 2
    • Global assessment of efficacy by patient and by Investigator
    • Percentage of patients requiring further medication (including rescue medication, see section 9.3) for treatment of acute pharyngitis during the clinical trial
    E.5.2.1Timepoint(s) of evaluation of this end point
    several timepoints depending on several endpoints
    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 No
    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) 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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA10
    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
    LSLV (Last patient last visit)
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    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 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 state140
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 220
    F.4.2.2In the whole clinical trial 220
    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
    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 Decision2019-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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