<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04470089</url>
  </required_header>
  <id_info>
    <org_study_id>MIRA1</org_study_id>
    <nct_id>NCT04470089</nct_id>
  </id_info>
  <brief_title>A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray</brief_title>
  <acronym>MIRA1</acronym>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Megainpharm GmbH</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Megainpharm GmbH</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this multi-center, randomized, placebo-controlled, double-blind stuy in which patients&#xD;
      with acute pharyngitis will receive Myramistin™ / Placebo, which is provided as a spray.&#xD;
      Patients will be randomised at Visit 1 on a 1:1:1:1 basis to one of the three MyramistinTM&#xD;
      doses (0.005%, 0.01% and 0.02%) or placebo. The trial duration for an individual patient is&#xD;
      72 hours.&#xD;
&#xD;
      The primary objective is to evaluate the short-term efficacy of different MyramistinTM doses&#xD;
      (0.005%, 0.01% and 0.02%) compared to placebo in the symptomatic treatment of acute&#xD;
      pharyngitis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to the COVID situation by end of 2021 and therfore limited recruitment of patients&#xD;
    diagnosis &quot;acute pharyngitis&quot; the study was terminated.&#xD;
  </why_stopped>
  <start_date type="Actual">February 18, 2020</start_date>
  <completion_date type="Actual">December 31, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity Differences</measure>
    <time_frame>2 hours</time_frame>
    <description>The primary endpoint is the Summed Pain Intensity Differences (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 time-weighted differences from each measured time point to baseline after dosing using the 100mm Visual Analogue Scale (VAS) Sore Throat Pain Intensity Scale (STPIS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Intensity Differences</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Pain Intensity Differences (PID) is summarized at different defined timepoints after first application on Day 1 (Baseline). The sum is calculated over the time-weighted differences from each measured time point to baseline after dosing using the 100mm VAS Sore Throat Pain Intensity Scale (STPIS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difficulty to Swallow Differences</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>SPID2-Swallow calculated analogously to the primary endpoint (including sensitivity analysis) using the Difficulty Swallowing Scale (DSS), furthermore it is calculated on different predefined timepoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Pain Relief</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to relief in Difficulty to Swallow</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Time to 30% and 50% relief in difficulty in swallowing (30% and 50% reduction in DSS) compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of symptom free patients</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>in throat pain at Visit 2 (STPIS=0)&#xD;
in difficulty in swallowing at Visit 2 (DSS=0)&#xD;
in throat pain and difficulty in swallowing at Visit 2 (STPIS=0 and DSS=0 - defined as complete</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tonsillo-Pharyngitis Assessment Scale</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Change in Tonsillo-Pharyngitis Assessment (TPA) sum-score and single symptom scores from baseline to Visit 2 Variables (findings like e.g. oral temperature, oropharyngeal colour, size of tonsilles etc.) presented are rated using the values 0, 1, 2 or 3 (points). The points are added together to make a TPA that can range from 0 to 21 points. Pharyngitis is present if a total score of ≥6 is obtained.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety Endpoints</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Type, frequency, severity and assessment of drug relationship of reported adverse events and will be descriptively evaluated and compared between treatment arms.</description>
  </other_outcome>
  <other_outcome>
    <measure>Tolerability Endpoints</measure>
    <time_frame>72+/-2 hours</time_frame>
    <description>Treatment differences in global assessment of tolerability will be tested using the Wilcoxon test adjusted for center (Van Elteren test) separately for patient and Investigator assessment.</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">170</enrollment>
  <condition>Acute Pharyngitis</condition>
  <arm_group>
    <arm_group_label>Myramistin 0.005%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Myramistin 0.01%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Myramistin 0.02%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Myramistin</intervention_name>
    <description>Oromucosal application</description>
    <arm_group_label>Myramistin 0.005%</arm_group_label>
    <arm_group_label>Myramistin 0.01%</arm_group_label>
    <arm_group_label>Myramistin 0.02%</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female at the ages of 18 to 75 years&#xD;
&#xD;
          2. Body Mass Index (BMI): 18-31 kg/m2&#xD;
&#xD;
          3. Willing and able to give informed consent&#xD;
&#xD;
          4. Clinically diagnosed acute pharyngitis.&#xD;
&#xD;
          5. Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1&#xD;
&#xD;
          6. Symptoms of acute pharyngitis such as sore throat and difficulty to swallow&#xD;
&#xD;
          7. Sore throat pain intensity scored as at least 60 mm on a 0-100 mm VAS (Visual Analogue&#xD;
             Scale) Sore Throat Pain Intensity Scale (STPIS)&#xD;
&#xD;
          8. Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing&#xD;
             Scale (DSS)&#xD;
&#xD;
          9. Tonsillo-Pharyngitis Assessment (TPA) ≥ 6 on 21-point TPA- scale&#xD;
&#xD;
         10. Absence of Group A Streptococcus as confirmed by a rapid swab test before&#xD;
             randomization&#xD;
&#xD;
         11. McIsaac - Score &lt;3&#xD;
&#xD;
         12. Willing to stay in the trial center for at least 2 hours (maximum 3 hrs) after the&#xD;
             first dose and return after 72 hours treatment on Day 4&#xD;
&#xD;
         13. Willing not to take anything by mouth excluding the investigational medical product&#xD;
             (IMP) and / or unable to abstain from smoking during the stay in the trial center.&#xD;
             Drinking of water is allowed.&#xD;
&#xD;
         14. Female patients must have&#xD;
&#xD;
               -  either a negative pregnancy test at Visit 1 and practicing a reliable method of&#xD;
                  contraception used consistently and correctly (including oral contraceptives,&#xD;
                  hormone implant, intrauterine device), or&#xD;
&#xD;
               -  must be postmenopausal (not spontaneous menstrual periods for at least 6 months)&#xD;
                  or&#xD;
&#xD;
               -  must be surgically sterile (tubal ligation or removal of ovaries or uterus)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with strong suspicion of Group A streptococcus infection. Either swab test is&#xD;
             positive OR McIsaac Score ≥ 3 points&#xD;
&#xD;
          2. Presence of signs or symptoms of any acute infection for which treatment with&#xD;
             antibiotics is mandatory and/or should not be postponed; i.e. accompanied fever (&gt;&#xD;
             38°C at Visit 1) and/or - if visually identified pharyngeal - presence of&#xD;
             seropurulent, purulent, fibro serous or fibrinous exudate from the pharyngeal mucosa&#xD;
&#xD;
          3. Patients with allergies or bronchial asthma who have a history of exacerbations within&#xD;
             30 days prior to trial inclusion&#xD;
&#xD;
          4. The use of any systemic analgesics / local analgesics in the throat area (e.g. Acetyl&#xD;
             Salicylic Acid = ASA &gt; 100 mg) during the trial or within 12 hours prior first study&#xD;
             medication application. Exception Paracetamol: intake of Paracetamol is allowed up to&#xD;
             6 hours before first application of IMP&#xD;
&#xD;
          5. The use of systemic antibiotics / local antibiotics in the throat area during the&#xD;
             trial and within the previous 7 days prior to Visit 1&#xD;
&#xD;
          6. The use of any systemic or local (i.e. in the throat area) antihistamines started&#xD;
             within 2 weeks prior to Visit 1&#xD;
&#xD;
          7. The use of any systemic anti-inflammatory drug / local anti-inflammatory drug in the&#xD;
             throat area (e.g. non-steroidal anti- inflammatory drugs or glucocorticoids) during&#xD;
             the trial or within 12 hours prior to first IMP application&#xD;
&#xD;
          8. The use of local anaesthetics for treatment of sore throat during the trial or within&#xD;
             12 hours prior to first IMP application&#xD;
&#xD;
          9. The use of any other 'sore throat medication' (e.g. lozenges, drops, sprays,&#xD;
             decongestants) or other 'cold medication' that could interfere the trial results&#xD;
             within the previous 12 hours prior to first study medication application&#xD;
&#xD;
         10. Major wounds of the mouth and throat&#xD;
&#xD;
         11. Immunodeficiency disorders (e.g. organ transplantation, HIV infection)&#xD;
&#xD;
         12. Existing cardiac, haematological, hepatic, renal, gastrointestinal, metabolic and / or&#xD;
             pathological findings, which might interfere with the drug's safety, tolerability and&#xD;
             / or absorption according to the judgement of the Investigator&#xD;
&#xD;
         13. Any neurological or psychiatric conditions, which might give the impression that the&#xD;
             patients will not comply with the protocol and trial needs&#xD;
&#xD;
         14. Patients with history (previous 5 years) or present condition of any malignancy&#xD;
&#xD;
         15. Known hypersensitivity to any ingredient of MyramistinTM&#xD;
&#xD;
         16. Previous participation in the trial&#xD;
&#xD;
         17. Parallel participation in any other trial during the previous 90 days before screening&#xD;
&#xD;
         18. History of alcohol or drug abuse&#xD;
&#xD;
         19. Known or suspected of being unable to comply with the clinical trial protocol (e.g. no&#xD;
             permanent address, history of drug abuse, known to be non-compliant or presenting an&#xD;
             unstable psychiatric history)&#xD;
&#xD;
         20. Legal incapacity and / or other circumstances rendering the patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>KAR</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUW</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Zentrum für Klinische Studien</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practive</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Duisburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Fulda</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Goch</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Köln</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>München</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Neuenhagen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Rosenheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Practice</name>
      <address>
        <city>Wuppertal</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>May 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>May 1, 2022</last_update_submitted>
  <last_update_submitted_qc>May 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pharyngitis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04470089
org study id: MIRA1
nct id: NCT04470089
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this multi-center, randomized, placebo-controlled, double-blind stuy in which patients
      with acute pharyngitis will receive Myramistin™ / Placebo, which is provided as a spray.
      Patients will be randomised at Visit 1 on a 1:1:1:1 basis to one of the three MyramistinTM
      doses (0.005%, 0.01% and 0.02%) or placebo. The trial duration for an individual patient is
      72 hours.

      The primary objective is 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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Pain Intensity Differences
time frame: 2 hours
description: The primary endpoint is the Summed Pain Intensity Differences (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 time-weighted differences from each measured time point to baseline after dosing using the 100mm Visual Analogue Scale (VAS) Sore Throat Pain Intensity Scale (STPIS).
measure: Pain Intensity Differences
time frame: 72+/-2 hours
description: Pain Intensity Differences (PID) is summarized at different defined timepoints after first application on Day 1 (Baseline). The sum is calculated over the time-weighted differences from each measured time point to baseline after dosing using the 100mm VAS Sore Throat Pain Intensity Scale (STPIS).
measure: Difficulty to Swallow Differences
time frame: 72+/-2 hours
description: SPID2-Swallow calculated analogously to the primary endpoint (including sensitivity analysis) using the Difficulty Swallowing Scale (DSS), furthermore it is calculated on different predefined timepoints.
measure: Time to Pain Relief
time frame: 72+/-2 hours
description: Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline.
measure: Time to relief in Difficulty to Swallow
time frame: 72+/-2 hours
description: Time to 30% and 50% relief in difficulty in swallowing (30% and 50% reduction in DSS) compared to baseline.
measure: Percentage of symptom free patients
time frame: 72+/-2 hours
description: in throat pain at Visit 2 (STPIS=0)
in difficulty in swallowing at Visit 2 (DSS=0)
in throat pain and difficulty in swallowing at Visit 2 (STPIS=0 and DSS=0 - defined as complete
measure: Tonsillo-Pharyngitis Assessment Scale
time frame: 72+/-2 hours
description: Change in Tonsillo-Pharyngitis Assessment (TPA) sum-score and single symptom scores from baseline to Visit 2 Variables (findings like e.g. oral temperature, oropharyngeal colour, size of tonsilles etc.) presented are rated using the values 0, 1, 2 or 3 (points). The points are added together to make a TPA that can range from 0 to 21 points. Pharyngitis is present if a total score of ≥6 is obtained.
measure: Safety Endpoints
time frame: 72+/-2 hours
description: Type, frequency, severity and assessment of drug relationship of reported adverse events and will be descriptively evaluated and compared between treatment arms.
measure: Tolerability Endpoints
time frame: 72+/-2 hours
description: Treatment differences in global assessment of tolerability will be tested using the Wilcoxon test adjusted for center (Van Elteren test) separately for patient and Investigator assessment.
arm group label: Myramistin 0.005%
arm group type: Experimental
arm group label: Myramistin 0.01%
arm group type: Experimental
arm group label: Myramistin 0.02%
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Myramistin
description: Oromucosal application
arm group label: Myramistin 0.005%
arm group label: Myramistin 0.01%
arm group label: Myramistin 0.02%
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Germany
responsible party type: Sponsor
mesh term: Pharyngitis