Pharyngitis
Conditions
Keywords
Dorithricin, Tyrothricin, Benzalkonium chloride, Benzocaine, placebo-controlled, Pharyngitis, sore throat, throat pain, difficulty swallowing, complete responder, lozenge, Non-streptococcal Infections
Brief 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.
Detailed description
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.
Interventions
DRUGBenzalkonium Chloride-Benzocaine Topical
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
DRUGPlacebo Oral Tablet
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.
Sponsors
University Hospital Muenster
Medice Arzneimittel Pütter GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
investigation: participant, care provider and investigator blinded assessment: participant, care provider and investigator blinded outcome analysis: statistician blinded
Intervention model description
randomized allocation of participants to verum or placebo (1:1)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| percentage of total responders assessed at Visit 2 (72 hours after first treatment) | 72 hours after first treatment | complete resolution of throat pain and difficulty in swallowing at Visit 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| percentage of total responders assessed after 48 hours after first treatment | 48 hours after first treatment | complete resolution of throat pain and difficulty in swallowing after 48 hours after first treatment |
| percentage of patients with complete resolution of throat pain 72 hours after first treatment | 72 hours after first treatment | complete resolution of throat pain after 72 hours after first treatment |
| percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment | 72 hours after first treatment | complete resolution of difficulty in swallowing after 72 hours after first treatment |
Countries
Germany
Outcome results
None listed