CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 204 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Flurbiprofen 8.75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01049334
NCT01049334Phase 3Completed

A Randomized, Double-Blind, Placebo-Controlled Multiple-Dose Study to Determine the Efficacy, Onset, and Duration of Action of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis

Reckitt Benckiser LLC·interventional·Posted Jan 14, 2010·Updated Sep 21, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo and Flurbiprofen for Pharyngitis. Completed, enrolled 204 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPharyngitis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 14, 2010
Enrollment StartNov 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.5 years ago

Interventions

Placebodrug

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.

Flurbiprofendrug

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.