A Phase 2 interventional study of Myramistin in Acute Pharyngitis, sponsored by Megainpharm GmbH. Terminated at 12 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Megainpharm GmbH · Phase 2, Interventional, and Treatment
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.
251 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's enrollment of 170 is above the median of 145 across 208 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →This is the only study on the registry with Megainpharm GmbH as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Female patients must have
Exclusion Criteria:
Drug: Myramistin
Drug: Myramistin
Drug: Myramistin
Drug: Myramistin
Oromucosal application
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
Safety Endpoints
Type, frequency, severity and assessment of drug relationship of reported adverse events and will be descriptively evaluated and compared between treatment arms.
Time frame: 72+/-2 hours
Tolerability Endpoints
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.
Time frame: 72+/-2 hours
This study is terminated, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.