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.
In this randomized, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (pain intensity on the 11-point Sore Throat Pain Intensity Scale NRS ≥7 and ≥50 mm on the subjective 0-100 mm visual analogue) are assigned to Dorithricin® or matching placebo lozenge treatment. Efficacy was assessed at the investigating center for 2 hrs after first dosing, and 3 days later (visit 2). The primary efficacy end-point is the percentage of total responders assessed at visit 2, i.e. complete resolution of throat pain and difficulty in swallowing at approx. 72 hrs after first application of treatment, Safety and local tolerability are also assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
321
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge. Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day.
doc-HNO for the DoriPha investigators
Röthenbach an der Pegnitz, Germany
percentage of total responders assessed at Visit 2 (72 hours after first treatment)
complete resolution of throat pain and difficulty in swallowing at Visit 2
Time frame: 72 hours after first treatment
percentage of total responders assessed after 48 hours after first treatment
complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment
Time frame: 48 hours after first treatment
percentage of patients with complete resolution of throat pain 72 hours after first treatment
complete resolution of throat pain after 72 hours after first treatment
Time frame: 72 hours after first treatment
percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
complete resolution of difficulty in swallowing after 72 hours after first treatment
Time frame: 72 hours after first treatment
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