Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis

Inclusion Criteria:

• Male and female outpatients aged ≥18 years

• Signed informed consent form

• Clinically diagnosed acute pharyngitis (TPA ≥5)

• Recent onset of symptoms (≤24 hours)

• Pain intensity of ≥8 on an 11-point NRS

• Difficulty in swallowing (100-mm VAS ≥50 mm)

Exclusion Criteria:

• Patients with strong suspicion of streptococcus A infection (McIsaac score ≥3)

• Positive rapid streptococcus A test (rapid antigen detection test) to exclude themajor bacterial pathogen responsible for sore throat

• Purulent tonsillitis

• The use of systemic/local antibiotics in the throat area within 7 days prior toscreening and during the study

• The use of any systemic analgesics/local analgesics in the throat area (e.g.non-steroidal drugs, [acetylsalicylic acid >100 mg], paracetamol) within 36 hoursprior to screening and during the study

• The use of local anaesthetics for treatment of sore throat within 2 days prior toscreening and during the study

• The use of any systemic anti-inflammatory drug/local anti-inflammatory drug in thethroat area (e.g. glucocorticoids) within 4 weeks prior to screening and during thestudy

• The use of any other 'sore throat medication' (e.g., lozenges, drops, sprays) or other 'cold medication' that could have interfered with the results of the study within 7days prior to screening and during the study