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https://hdl.handle.net/11055/572
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DC Field | Value | Language |
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dc.contributor.author | Bouroubi A | en_US |
dc.contributor.author | Donazzolo Y | en_US |
dc.contributor.author | Donath F | en_US |
dc.contributor.author | Eccles R | en_US |
dc.contributor.author | Russo M | en_US |
dc.contributor.author | Harambillet N | en_US |
dc.contributor.author | Gautier S | en_US |
dc.contributor.author | Montagne A | en_US |
dc.date | 2017-09-04 | - |
dc.date.accessioned | 2018-06-15T01:03:55Z | - |
dc.date.available | 2018-06-15T01:03:55Z | - |
dc.date.issued | 2017-09-04 | - |
dc.identifier.citation | 71(9):e12961 | en_US |
dc.identifier.uri | http://hdl.handle.net/11055/572 | - |
dc.description.abstract | OBJECTIVE: The aim of this study was to compare the efficacy and safety of a new oromucosal ibuprofen form, ibuprofen 25 mg lozenge, in single and repeat dosing for up to 4 days, to the matched placebo, in the treatment of acute sore throat pain in adults. METHODS: In this randomised, double-blind, placebo-controlled trial, adult patients with non-streptococcal sore throat and signs of moderate-to-severe associated pain (≥5 on the objective Tonsillo-Pharyngitis Assessment 21-point scale and ≥60 mm on the subjective 0-100 mm visual analogue Sore Throat Pain Intensity Scale [STPIS]) were assigned ibuprofen 25 mg (n=194) or matching placebo (n=191) lozenge treatment. Efficacy was assessed (at the investigating centre up to 2 hours after first dosing, then on an ambulatory basis) by parameters derived from patient's scores on scales of pain relief, pain intensity, and global efficacy assessment. The primary efficacy end-point was the time-weighted TOTal PAin Relief (TOTPAR) over 2 hours after first dosing using the Sore Throat Relief Scale (STRS). Safety and local tolerability were assessed. RESULTS: Ibuprofen 25 mg was superior to placebo on numerous pain relief parameters; TOTPAR was significantly higher with ibuprofen 25 mg over 2 hours after first dosing (P<.05), the effect being apparent from the first evaluation at 15 minutes (P<.05). The STPIS reduction in favour of ibuprofen 25 mg was not significant vs placebo. Mean STRS scores and patient's global efficacy assessment both reflected a higher efficacy of ibuprofen 25 mg over the 4-day treatment period with tests of statistical significance up to day 1 evening (P<.05), and, in patients with still clinically significant pain (n=128), after an average 4 days (P<.01). Ibuprofen 25 mg lozenge was well tolerated with a safety profile similar to placebo. CONCLUSION: Low-dose ibuprofen 25 mg lozenge in repeat dosing provides in adults more efficacious and rapid relief of sore throat pain and is as well tolerated as placebo. | en_US |
dc.subject | sore throat | en_US |
dc.subject | pain relief | en_US |
dc.subject | lozenge | en_US |
dc.subject | ibuprofen | en_US |
dc.subject | pharyngitis | en_US |
dc.title | Pain relief of sore throat with a new anti-inflammatory throat lozenge, ibuprofen 25 mg: A randomised, double-blind, placebo-controlled, international phase III study | en_US |
dc.type | Journal Article | en_US |
dc.type.content | Text | en_US |
dc.identifier.journaltitle | International Journal of Clinical Practice | en_US |
dc.identifier.doi | 10.1111/ijcp.12961 | en_US |
dc.description.affiliates | Centre de Recherche et Développement Pierre Fabre, Toulouse, France | en_US |
dc.description.affiliates | Eurofins Optimed, Gières, France | en_US |
dc.description.affiliates | SocraTec R&D GmbH, Oberursel, Germany | en_US |
dc.description.affiliates | Common Cold Centre, Cardiff University, Cardiff, UK | en_US |
dc.description.affiliates | Hunter Pain Clinic, Newcastle, New South Wales, Australia | en_US |
dc.description.pubmeduri | https://www.ncbi.nlm.nih.gov/pubmed/28869722 | en_US |
dc.type.studyortrial | Randomized Controlled Clinical Trial/Controlled Clinical Trial | en_US |
dc.identifier.studyname | NCT01785862 | en_US |
dc.ispartof.anzcaresearchfoundation | Yes | en_US |
local.message.claim | 2023-05-02T12:05:54.601+1000|||rp00166|||submit_approve|||dc_contributor_author|||None | * |
dc.type.specialty | Anaesthesia | en_US |
item.cerifentitytype | Publications | - |
item.fulltext | With Fulltext | - |
item.openairecristype | http://purl.org/coar/resource_type/c_18cf | - |
item.openairetype | Journal Article | - |
item.grantfulltext | reserved | - |
Appears in Collections: | Scholarly and Clinical |
Files in This Item:
File | Description | Size | Format | |
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Pain relief of sore throat with a new anti-inflammatory throat lozenge ibuprofen 25 mg (ID 55845).pdf Restricted Access | 724.82 kB | Adobe PDF | View/Open Request a copy |
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