Clinical trial NCT03323528: Safety and Efficacy of a Sore Throat Lozenge DORITHRICIN in Patients With Acute Pharyngitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pharyngitis
Keywords: Dorithricin
Tyrothricin
Benzalkonium chloride
Benzocaine
placebo-controlled
Pharyngitis
sore throat
throat pain
difficulty swallowing
complete responder
lozenge
Non-streptococcal Infections
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Muenster
First posted: 2017-10-27
Enrollment: 321
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized allocation of participants to verum or placebo (1:1)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: percentage of total responders assessed at Visit 2 (72 hours after first treatment)
timeFrame: 72 hours after first treatment
Secondary outcomes:
measure: percentage of total responders assessed after 48 hours after first treatment
timeFrame: 48 hours after first treatment
measure: percentage of patients with complete resolution of throat pain 72 hours after first treatment
timeFrame: 72 hours after first treatment
measure: percentage of patients with complete resolution of difficulty in swallowing 72 hours after first treatment
timeFrame: 72 hours after first treatment
Other outcomes:
Locations:
city: Röthenbach an der Pegnitz
country: Germany
facility: doc-HNO for the DoriPha investigators
Study officials:
affiliation: MEDICE Arzneimittel Puetter GmbH&Co.KG
name: R Ammer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Universtiy hospital Muenster, MedD
name: R Ammer, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Palm J, Fuchs K, Stammer H, Schumacher-Stimpfl A, Milde J; DoriPha investigators. Efficacy and safety of a triple active sore throat lozenge in the treatment of patients with acute pharyngitis: Results of a multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial (DoriPha). Int J Clin Pract. 2018 Dec;72(12):e13272. doi: 10.1111/ijcp.13272. Epub 2018 Oct 17.