NCT04941976

Benzydamine in Sore Throat Pain Relief (BePaiR Study)

Phase IV Study Comparing the Efficacy and Safety of Benzydamine Hydrochloride 0,3% Oromucosal Spray and Benzydamine Hydrochloride 3 mg Lozenges in Patients With Acute Sore Throat

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Aziende Chimiche Riunite Angelini Francesco S.p.A · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray vs Benzydamine hydrochloride 3 mg lozenges mint flavour.

Detailed description

The efficacy and safety of benzydamine local-applied, in the treatment of various throat inflammatory and painful conditions, had been widely demonstrated. The aim of this study is to generate new clinical data about the speed of relief provided by a single application of Benzydamine hydrochloride 0,3% oromucosal spray or Benzydamine hydrochloride 3 mg lozenges mint flavour. The study will be conducted at 15 sites located among Poland, Hungary and Russia (5 sites for each country). 356 patients affected by acute sore throat will be enrolled in out-patient clinics or out-patient departments of city hospitals.

Conditions

• Acute Sore Throat

Interventions

Type	Name	Description
DRUG	0.3% benzydamine hydrochloride spray oromucosal solution	Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0. In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.
DRUG	Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)	Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0. In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution.

Timeline

• Start date: 2020-08-13
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2021-06-28
• Last updated: 2021-07-22

Locations

17 sites across 3 countries: Hungary, Poland, Russia