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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-centre, Randomized, Placebo-controlled, Double-blind, Parallel-group Study Investigating Safety and Efficacy of a Sore Throat Lozenge in the Symptomatic Treatment of Patients With Acute Pharyngitis

Conditions
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Pharyngitis

Intervention / Treatment
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* Drug: Benzalkonium Chloride-Benzocaine Topical
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized allocation of participants to verum or placebo (1:1)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dorithricin<br>Dorithricin throat lozenges is a fixed combination of three active substances: Benzalkonium Chloride-Benzocaine Topical plus tyrothricin. Lozenge has to be sucked slowly until it fully dissolves in the mouth and dosed up to 8 lozenges per day. Test product without mint oil. Intervention: The initial dose is administered at the study site. Patients administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day. | Drug: Benzalkonium Chloride-Benzocaine Topical<br>* Dorithricin = tyrothricin, benzalkonium chloride, benzocaine<br>* Other names: triple combination;|
| Placebo Comparator: Placebo<br>Placebo Oral Tablet is taken orally. Placebo consists of a lozenge with matched appearance and the same excipients as those of the Dorithricin lozenge. The initial dose (2 lozenges simultaneously) is administered at the study site. 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. | Drug: Placebo Oral Tablet<br>* 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.<br>* Other names: Placebo lozenge;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 72 hours after first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 72 hours after first treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benzocaine, Benzalkonium chloride, Dorithricin, Tyrothricin, placebo-controlled, Pharyngitis, sore throat, throat pain, difficulty swallowing, complete responder, lozenge, Non-streptococcal Infections