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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
170
Oromucosal application
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
...and 2 more locations
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
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
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
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
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
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
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
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