CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 122 enrolled
Drug / intervention
flurbiprofen +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/NCT01986361
NCT01986361Phase 3Completed
CompareCT.gov

A Single-Dose, Randomized, Double-Blind, Placebo-Controlled Onset-of-Action Study Utilizing the Double-Stopwatch Method

Reckitt Benckiser LLC·interventional·Posted Nov 18, 2013·Updated Sep 28, 2017

In Brief

A Phase 3 clinical trial evaluating flurbiprofen and placebo for Acute Pharyngitis and Sore Throat. Completed, enrolled 122 participants across 1 site.

Detailed Summary

The study's purpose is to demonstrate the onset of action, i.e., time to meaningful pain relief in patients with pharyngitis, of flurbiprofen 8.75 mg lozenge using the Double-Stopwatch Method (DSW).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pharyngitis, Sore Throat
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 18, 2013
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.6 years ago

Interventions

flurbiprofendrug

A single flurbiprofen 8.75 mg lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.

placebodrug

A single placebo lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.