A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatmen… (NCT04470089) | Clinical Trial Compass
TerminatedPhase 2
A Clinical Trial Investigating the Short-term Relief of Symptoms of Acute Pharyngitis by Treatment With Three Different Doses of MYRAMISTIN™ Oromucosal Spray
Stopped: Due to the COVID situation by end of 2021 and therfore limited recruitment of patients diagnosis "acute pharyngitis" the study was terminated.
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
âś“. Male and female at the ages of 18 to 75 years
âś“. Body Mass Index (BMI): 18-31 kg/m2
âś“. Willing and able to give informed consent
âś“. Clinically diagnosed acute pharyngitis.
âś“. Onset of symptoms of acute pharyngitis within the past 48 hours prior to Visit 1
âś“. Symptoms of acute pharyngitis such as sore throat and difficulty to swallow
âś“. 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)
âś“. Difficulty in swallowing of at least 60 mm on a 0-100 mm VAS Difficulty Swallowing Scale (DSS)
Exclusion criteria
✕. 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
âś•. Patients with allergies or bronchial asthma who have a history of exacerbations within 30 days prior to trial inclusion
âś•. 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
âś•. The use of systemic antibiotics / local antibiotics in the throat area during the trial and within the previous 7 days prior to Visit 1
âś•. The use of any systemic or local (i.e. in the throat area) antihistamines started within 2 weeks prior to Visit 1
âś•. 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
âś•. The use of local anaesthetics for treatment of sore throat during the trial or within 12 hours prior to first IMP application