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Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis "acute pharyngitis" the study was terminated.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myramistin 0.005% | Experimental |
| |
| Myramistin 0.01% | Experimental |
| |
| Myramistin 0.02% | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myramistin | Drug | Oromucosal application |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 72+/-2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoints | Type, frequency, severity and assessment of drug relationship of reported adverse events and will be descriptively evaluated and compared between treatment arms. | 72+/-2 hours |
| Tolerability Endpoints |
Inclusion Criteria:
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
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KAR | Vienna | Austria | ||||
| MUW |
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| 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. |
| 72+/-2 hours |
| Time to Pain Relief | Time to 30% and 50% pain relief (30% and 50% reduction in STPIS) compared to baseline. | 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. | 72+/-2 hours |
| Percentage of symptom free patients |
| 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. | 72+/-2 hours |
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.
| 72+/-2 hours |
| 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 |
| Practice | Rosenheim | Germany |
| Practice | Wuppertal | Germany |
| ID | Term |
|---|---|
| C058048 | miramistin |
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