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A Study of Flurbiprofen 8.75 mg Lozenge in Patients With Pharyngitis

NCT01048866 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 198

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

Sugar-based lozenge flavoured to match the active treatment lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for sore throat pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.

DRUG

flurbiprofen

Sugar-based, flavoured flurbiprofen 8.75 mg lozenge. Instructions were to suck one lozenge until gone, every 3-6 hours as needed for pain. The participant took nothing by mouth except study medication during the first two hours while at the site. For each re-dosing during the remaining time in the study, alcohol and caffeine-containing beverages (e.g., coffee, tea, hot chocolate, caffeinated soft drinks) were not consumed within 1 hour before the participant used a study medication lozenge.

DRUG

acetaminophen 650mg

Rescue medication to be taken as needed. Rescue medication was not blinded.

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

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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 NCT01048866 on ClinicalTrials.gov