Loading clinical trials...

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

TERMINATEDPHASE2

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

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

NCT04470089•Megainpharm GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+7 more 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
+10 more criteria

Locations (12)

KAR

Vienna, Austria

MUW

Vienna, Austria

Zentrum für Klinische Studien

Vienna, Austria

Practive

Berlin, Germany

Practice

Cologne, Germany

Practice

Duisburg, Germany

Practice

Fulda, Germany

Practice

Goch, Germany

Practice

München, Germany

Practice

Neuenhagen, Germany

Key Dates

Start Date

February 18, 2020

Primary Completion Date

December 31, 2021

Completion Date

December 31, 2021

Last Updated

May 5, 2022

Enrollment

170

ACTUAL participants

Conditions

Acute Pharyngitis

Interventions

Myramistin

DRUG

Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial

NCT06932328

Acute Pharyngitis

View study

COMPLETEDPHASE2/PHASE3

Inhaled Steroids for Acute Pharyngitis.

NCT04027322

Acute Pharyngitis

View study

COMPLETED

Non Interventional Study (NIS) Regarding the Application of Ectoin Mund- & Rachenspray in Patients With Acute Laryngitis and/or Acute Pharyngitis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 5, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions