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

Pharyngitis Clinical Trial

— DoriPha  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03323528
• Other study ID #: 2016-003962-24
• Status: Completed
• Phase: Phase 4
• First received: October 24, 2017
• Last updated: November 24, 2017
• Start date: February 1, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: October 2017
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: November 15, 2017
• Est. primary completion date: July 2, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Pharyngitis

Intervention

Drug:
• Benzalkonium Chloride-Benzocaine Topical
Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
• Placebo 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.

Locations

Country	Name	City	State
Germany	doc-HNO for the DoriPha investigators	Röthenbach an der Pegnitz

Sponsors (2)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG	University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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

External Links

•   Test product description