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

Medice Arzneimittel

Status and phase: Completed; Phase 4

Conditions: Pharyngitis

Treatments: Drug: Benzalkonium Chloride-Benzocaine Topical; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03323528

2016-003962-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 321 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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321 participants in 2 patient groups, including a placebo group

Dorithricin

Active Comparator group

Description:

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.

Treatment:

Drug: Benzalkonium Chloride-Benzocaine Topical

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo Oral Tablet