Evidence map›Paper›PMID 24988909›Full record

Trial reportTrials2014

Utility of the sore throat pain model in a multiple-dose assessment of the acute analgesic flurbiprofen: a randomized controlled study.

Bernard Schachtel, Sue Aspley, Adrian Shephard, Timothy Shea, Gary Smith, Emily Schachtel

2 registry-linked trialsOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 19% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01048866 phase3completednot on this map

A Repeat-Dose, Multi-Centre, Randomized, Double-Blind, Placebo-Controlled, Study to Determine the Safety and Efficacy of Flurbiprofen 8.75 mg Lozenge Compared to Its Vehicle Control Lozenge in Patients With Painful Pharyngitis

TypeinterventionalSponsorReckitt Benckiser LLCRan2009 to 2011Enrolled198ConditionsPharyngitisArmsplacebo, flurbiprofen, acetaminophen 650mg
NCT06106880 phase1completednot on this mapstarted 2022, after this paper: background citation

Alleviation of Upper Respiratory Inflammation and Associated Common Cold Symptoms

TypeinterventionalSponsorApplied Biological Laboratories IncRan2022 to 2023Enrolled157ConditionsCommon Cold, Pharyngitis, Fever, CongestionArmsWintergreen Throat Spray and Aspirin Tablet, Aspirin Throat Spray and Placebo Tablet, Wintergreen Throat Spray and Placebo Tablet, Placebo Throat Spray and Placebo Tablet
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 2 countries.

Bernard SchachtelDepartment of Epidemiology & Public Health, Yale University School of Medicine, 60 College Street, New Haven, CT 06520-8034, USA. bschachtel@srcresearch.net.
Sue Aspley
Adrian Shephard
Timothy Shea
Gary Smith
Emily Schachtel
Reckitt Benckiser (United Kingdom) · GBBechtel (United States) · USYale University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of lozenges containing flurbiprofen at 8.75 mg.

methodsAdults (n=198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg lozenges (n=101) or matching placebo lozenges (n=97) under double-blind conditions. Patients sucked one lozenge every three to six hours as needed, up to five lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS).

resultsReductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg lozenge (P<0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P<0.01). There were no serious adverse events.

conclusionsUtilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model.

trial registrationThis trial was registered with ClinicalTrials.gov, registration number: NCT01048866, registration date: January 13, 2010.

Indexed as

Administration, OralAdolescentAdultAnalgesicsDeglutitionDouble-Blind MethodDrug Administration ScheduleFemaleFlurbiprofenHumansMaleMiddle AgedPainPain MeasurementPharyngitisSeverity of Illness IndexAnalgesicsFlurbiprofenTablets

Identifiers

PMID24988909
PMCPMC4227086
OpenAlexW2073017111

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.