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

NCT04470089 | Terminated Phase 2

• 1 other identifier: MIRA1
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 12

Brief 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.

Conditions

Acute Pharyngitis

Outcome Measures

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).

  2 hours

Secondary Outcomes (6)

• Pain Intensity Differences

  72+/-2 hours

• Difficulty to Swallow Differences

  72+/-2 hours

• Time to Pain Relief

  72+/-2 hours

• Time to relief in Difficulty to Swallow

  72+/-2 hours

• Percentage of symptom free patients

  72+/-2 hours

Other Outcomes (2)

• Safety Endpoints

  72+/-2 hours

• Tolerability Endpoints

  72+/-2 hours

Study Arms (4)

Myramistin 0.005%

EXPERIMENTAL

Drug: Myramistin

Myramistin 0.01%

EXPERIMENTAL

Drug: Myramistin

Myramistin 0.02%

EXPERIMENTAL

Drug: Myramistin

Placebo

PLACEBO COMPARATOR

Drug: Myramistin

Interventions

Myramistin DRUG

Oromucosal application

Myramistin 0.005%; Myramistin 0.01%; Myramistin 0.02%; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Megainpharm GmbH: lead

Study Sites (12)

KAR

Vienna, Austria

Location

MUW

Vienna, Austria

Location

Zentrum für Klinische Studien

Vienna, Austria

Location

Practive

Berlin, Germany

Location

Practice

Cologne, Germany

Location

Practice

Duisburg, Germany

Location

Practice

Fulda, Germany

Location

Practice

Goch, Germany

Location

Practice

München, Germany

Location

Practice

Neuenhagen, Germany

Location

Practice

Rosenheim, Germany

Location

Practice

Wuppertal, Germany

Location

MeSH Terms

Interventions

miramistin

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: July 14, 2020
• Study Start: February 18, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Locations

AU (3); DE (9)