Ibuprofen Lozenge in Acute Sore Throat Pain

Phase 3 Completed 427 enrolled Pierre Fabre Laboratories

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of repeated doses of a low dosage of oromucosal Ibuprofen form (lozenge) versus placebo in patients suffering from acute sore throat pain.

Timeline

Start: 2013-02
Primary completion: 2013-06
Completion: 2013-06

Outcome

Met primary endpoint

paper TOTPAR was significantly higher with ibuprofen 25 mg over 2 hours after first dosing (P<.05) PMID 28869722 ↗

Publications

Bouroubi A, Donazzolo Y, Donath F, Eccles R, Russo M, Harambillet N, Gautier S, Montagne A. 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. Int J Clin Pract. 2017 Sep;71(9). doi: 10.1111/ijcp.12961. Epub 2017 Sep 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ibuprofen	Small molecule	25 mg	Other