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

• Status: Completed
• Trial end date: 2017-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this multi-center, randomized, double-blind, placebo-controlled trial is to compare the efficacy and safety of Dorithricin® lozenge - a triple combination of 0.5 mg tyrothricin, 1.0 mg benzalkonium chloride, and 1.5 mg benzocaine - in repeat dosing for 3 days to matched placebo lozenges in the treatment of acute pharyngitis in adults.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Collaborators: Milde J, Pharmalog; Palm J, for the DoriPha investigators; University Hospital Muenster
• Treatments: Benzalkonium Compounds; Benzocaine; Tyrothricin

Criteria

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 the major bacterial pathogen responsible for sore throat

• Purulent tonsillitis

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

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

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

• 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 7 days prior to screening and during the study