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Br J Pain. 2018 Nov;12(4):208-216. doi: 10.1177/2049463718756152. Epub 2018 Jan 25.

Onset of analgesia by a topically administered flurbiprofen lozenge: a randomised controlled trial using the double stopwatch method.

Author information

1
Schachtel Research Company, Inc., Jupiter, FL, USA.
2
Yale School of Public Health, New Haven, CT, USA.
3
Reckitt Benckiser Healthcare Ltd, Slough, UK.
4
Reckitt Benckiser, Parsippany, NJ, USA.

Abstract

Background:

The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs.

Objective:

The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge.

Methods:

Adults with acute sore throat (n = 122) were examined to confirm the presence of tonsillopharyngitis (Tonsillo-Pharyngitis Assessment) and sore throat pain of at least moderate intensity (≥6 on a 0-10 Sore Throat Scale). Lozenges containing flurbiprofen 8.75 mg or inert ingredients (identically flavoured) were administered under double-blind conditions in the clinic while patients assessed pain and pain relief over 3 hours. Onset of analgesia was determined using the DSW method and reported as the Kaplan-Meier median time to meaningful relief. The median time to first perceived relief was also documented.

Results:

About 78% of flurbiprofen-treated patients reported meaningful pain relief compared with 48% of placebo-treated patients (p < 0.01); median time to meaningful relief for flurbiprofen-treated patients was 43 minutes (placebo-treated patients were right-censored due to non-responsivity; p = 0.01). Median time to first perceived pain relief was 11 minutes for flurbiprofen-treated patients and 19 minutes for placebo-treated patients (p = 0.03). Flurbiprofen lozenge was well tolerated, with no serious adverse events occurring and no patient discontinuing due to an adverse event.

Conclusion:

These results indicate that the DSW method can be successfully applied to the evaluation of the onset of action of a locally administered analgesic in patients with acute sore throat, demonstrating that the onset of action (time to meaningful pain relief) of flurbiprofen lozenge was <45 minutes.

KEYWORDS:

Double stopwatch method; flurbiprofen; onset of action; pharyngitis; sore throat; topical analgesia

PMID:
30349694
PMCID:
PMC6194974
[Available on 2019-11-01]
DOI:
10.1177/2049463718756152

Conflict of interest statement

Conflict of interest: A.S. and T.S. are employees of Reckitt Benckiser Healthcare Ltd, UK, as was S.A. at the time of preparation of the manuscript. B.S., M.B.L. and E.S. (at Schachtel Research Company) received a research grant from Reckitt Benckiser to design and conduct the study.

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