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Acute PharyngitisPhase 2MIRA1NCT04470089

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 study testing Myramistin in people with Acute Pharyngitis, run by Megainpharm GmbH at 12 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Pharyngitis
What is being tested?
Myramistin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
170 participants
Where
12 sitesin 2 countries
Study dates
18 Feb 2020to 31 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female at the ages of 18 to 75 years
  • Body Mass Index (BMI): 18-31 kg/m2
  • Willing and able to give informed consent
  • Clinically diagnosed acute pharyngitis.
  • Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1
  • Symptoms of acute pharyngitis such as sore throat and difficulty to swallow
Show all 17Show fewer
  • 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)
  • Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing Scale (DSS)
  • Tonsillo-Pharyngitis Assessment (TPA) ≥ 6 on 21-point TPA- scale
  • Absence of Group A Streptococcus as confirmed by a rapid swab test before randomization
  • McIsaac - Score <3
  • 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
  • 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.
  • 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)

Who cannot join

  • Patients with strong suspicion of Group A streptococcus infection. Either swab test is positive OR McIsaac Score ≥ 3 points
  • 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
  • Patients with allergies or bronchial asthma who have a history of exacerbations within 30 days prior to trial inclusion
  • 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
  • The use of systemic antibiotics / local antibiotics in the throat area during the trial and within the previous 7 days prior to Visit 1
  • The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to Visit 1
Show all 20Show fewer
  • 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
  • The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first IMP application
  • 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
  • Major wounds of the mouth and throat
  • Immunodeficiency disorders (e.g. organ transplantation, HIV infection)
  • 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
  • Any neurological or psychiatric conditions, which might give the impression that the patients will not comply with the protocol and trial needs
  • Patients with history (previous 5 years) or present condition of any malignancy
  • Known hypersensitivity to any ingredient of MyramistinTM
  • Previous participation in the trial
  • Parallel participation in any other trial during the previous 90 days before screening
  • History of alcohol or drug abuse
  • 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)
  • Legal incapacity and / or other circumstances rendering the patients

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

Germany9 sites

  • Practive

    Berlin

  • Practice

    Cologne

  • Practice

    Duisburg

  • Practice

    Fulda

  • Practice

    Goch

  • Practice

    München

  • Practice

    Neuenhagen

  • Practice

    Rosenheim

  • Practice

    Wuppertal

Other trials in Germany

Austria3 sites

  • KAR

    Vienna

  • MUW

    Vienna

  • Zentrum für Klinische Studien

    Vienna

Other trials in Austria

About this study

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

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.

Being tested
Myramistin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MyramistinDrug

    Oromucosal application

Study groups in NCT04470089
Study groupRoleWhat they receive
Myramistin 0.005%ExperimentalNot described
Receives: Drug: Myramistin
Myramistin 0.01%ExperimentalNot described
Receives: Drug: Myramistin
Myramistin 0.02%ExperimentalNot described
Receives: Drug: Myramistin
PlaceboPlacebo comparatorNot described
Receives: Drug: Myramistin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 2 hours

Secondary outcomes (6)

  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).

    Measured: 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.

    Measured: 72+/-2 hours

  3. Time to Pain Relief

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

    Measured: 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.

    Measured: 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

    Measured: 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.

    Measured: 72+/-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2020
  2. Study start18 Feb 2020
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04470089
Sponsor's protocol ID
MIRA1
Acronym
MIRA1
Status last verified
May 2022
First submitted
19 May 2020
Last updated
5 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Myramistin in people with Acute Pharyngitis, run by Megainpharm GmbH at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Germany, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis "acute pharyngitis" the study was terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Intensity Differences (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470089.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.

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