MedTrace Logo

Benzydamine in Sore Throat Pain Relief (BePaiR Study)

NCT04941976 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2021-07-22

No results posted yet for this study

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.

Conditions

  • Acute Sore Throat

Interventions

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.

Sponsors & Collaborators

  • Zak-Pharma Dienstleistung Ges.m.b.H.

    collaborator UNKNOWN

  • Aziende Chimiche Riunite Angelini Francesco S.p.A

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-06-30
Completion
2021-06-30

Countries

  • Hungary
  • Poland
  • Russia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941976 on ClinicalTrials.gov