CClinicalTrials.gg
TerminatedNCT04470089MIRA1Updated May 5, 2022

A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray

A Phase 2 interventional study of Myramistin in Acute Pharyngitis, sponsored by Megainpharm GmbH. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Megainpharm GmbH · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis "acute pharyngitis" the study was terminated.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Feb 2020, registered May 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
170
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Acute Pharyngitis

Browse trials for

03

In context

Pharyngitis

251 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.

This study's enrollment of 170 is above the median of 145 across 208 interventional studies indexed under Pharyngitis.

Browse Pharyngitis studies →

Lead sponsor

This is the only study on the registry with Megainpharm GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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 (Visual Analogue Scale) 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 Group A Streptococcus as confirmed by a rapid swab test before randomization
  11. McIsaac - Score \<3
  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 investigational medical product (IMP) and / or unable to abstain from smoking during the stay in the trial center. Drinking of water is allowed.
  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 (not spontaneous menstrual periods for at least 6 months) or
    • must be surgically sterile (tubal ligation or removal of ovaries or uterus)

Exclusion criteria

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 IMP
  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 to first IMP application
  8. The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first IMP 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
  16. Previous participation in the trial
  17. Parallel participation in any other trial 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
170 participants (actual)

Study arms

  • Experimental
    Myramistin 0.005%

    Drug: Myramistin

  • Experimental
    Myramistin 0.01%

    Drug: Myramistin

  • Experimental
    Myramistin 0.02%

    Drug: Myramistin

  • Placebo comparator
    Placebo

    Drug: Myramistin

Interventions

  • DrugMyramistin

    Oromucosal application

06

What researchers measure

Primary outcomes

  1. Pain Intensity Differences

    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).

    Time frame: 2 hours

Secondary outcomes

  1. Pain Intensity Differences

    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).

    Time frame: 72+/-2 hours

  2. Difficulty to Swallow Differences

    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.

    Time frame: 72+/-2 hours

  3. Time to Pain Relief

    Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline.

    Time frame: 72+/-2 hours

  4. Time to relief in Difficulty to Swallow

    Time to 30% and 50% relief in difficulty in swallowing (30% and 50% reduction in DSS) compared to baseline.

    Time frame: 72+/-2 hours

  5. Percentage of symptom free patients

    * 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

    Time frame: 72+/-2 hours

  6. Tonsillo-Pharyngitis Assessment Scale

    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.

    Time frame: 72+/-2 hours

Other outcomes

  1. Safety Endpoints

    Type, frequency, severity and assessment of drug relationship of reported adverse events and will be descriptively evaluated and compared between treatment arms.

    Time frame: 72+/-2 hours

  2. Tolerability Endpoints

    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.

    Time frame: 72+/-2 hours

07

Study locations

12 sites
  • KAR
    Wien, Austria
  • MUW
    Wien, Austria
  • Zentrum für Klinische Studien
    Wien, Austria
  • Practive
    Berlin, Germany
  • Practice
    Duisburg, Germany
  • Practice
    Fulda, Germany
  • Practice
    Goch, Germany
  • Practice
    Köln, Germany
  • Practice
    München, Germany
  • Practice
    Neuenhagen, Germany
  • Practice
    Rosenheim, Germany
  • Practice
    Wuppertal, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04470089
Lead sponsor
Megainpharm GmbH
Responsible party
Sponsor
First posted
Jul 14, 2020
Start date
Feb 18, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
May 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion