Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis (NCT03323528) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis
Germany321 participantsStarted 2017-02-01
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
percentage of total responders assessed at Visit 2 (72 hours after first treatment)