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A Study to Determine the Efficacy and Safety of a Benzocaine Lozenge for Treatment of Sore Throat.

NCT03432923 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2018-10-18

No results posted yet for this study

Summary

A multi-center, double-blind, randomized, parallel-group, placebo-controlled study to determine the efficacy and safety of a benzocaine lozenge for symptomatic treatment of sore throat caused by acute upper respiratory tract infection in adults.

Conditions

  • Sore Throat

Interventions

DRUG

Benzocaine 8 mg

Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.

DRUG

Placebo

Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • McNeil AB

    lead INDUSTRY

Principal Investigators

  • Steven Sacavage · Medical Affairs and Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-02
Primary Completion
2018-04-21
Completion
2018-04-21

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03432923 on ClinicalTrials.gov