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A Study of Flurbiprofen 8.75 mg Lozenge in Patient With Pharyngitis

NCT01049334 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2017-09-21

Study results available
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Summary

The purposes of this study is to demonstrate the analgesic efficacy of flurbiprofen 8.75 mg lozenge compared to its vehicle lozenge and to demonstrate the safety of the flurbiprofen lozenge throughout the course of treating sore throat due to acute pharyngitis.

Conditions

  • Pharyngitis

Interventions

DRUG

Placebo

Participants were instructed to suck one placebo lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.

DRUG

Flurbiprofen

Participants were instructed to suck one flurbiprofen 8.75 mg lozenge during the initial two-hour clinic visit. Upon discharge, participants were instructed to use study medication lozenge every 3-6 hours as needed for pain, up to a total of 5 study lozenges in 24 hours.

Sponsors & Collaborators

  • Reckitt Benckiser LLC

    lead INDUSTRY

Principal Investigators

  • Timothy J Shea, BS · Reckitt Benckiser Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • United States

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 NCT01049334 on ClinicalTrials.gov