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To compare the safety and effectiveness of a new Ibuprofen 25 mg lozenge, in single and repeat dosing for four days, to the matched placebo, to manage acute sore throat pain within adults.
Sore throat is characterised by inflammation of larynx, pharynx and tonsils and is typically associated with pain upon swallowing. Widely recommended oral and systemic Ibuprofen repots various adverse reactions and low bioavailability. Therefore, in this trial it has revealed that Ibuprofen lozenge is more efficacious and safer than the oral and systemic from.
To compare the safety and effectiveness of a new Ibuprofen 25 mg lozenge, in single and repeat dosing for four days, to the matched placebo, to manage acute sore throat pain within adults.
A total of 194 and 191 patients with a non-streptococcal sore throat and moderate-to-severe related pain were obtained 25 mg Ibuprofen and resembling placebo (n=191) lozenge, respectively. Efficiency was evaluated by parameters derived from patient's scores on scales of pain relief, intensity, pain and global efficacy estimation. The measured time-weighted TOTal PAin Relief (TOTPAR) above 2 hours following the first dosing applying the Sore Throat Relief Scale (STRS) was taken as the primary endpoint. Local tolerability and safety were also determined.
Ibuprofen 25 mg exhibited better values of numerous pain relief parameters as compared to the placebo. The TOTPAR was considerably greater with Ibuprofen 25 mg over 2 hours following the first dosing. The STPIS decline by Ibuprofen 25 mg was not significant than placebo. Patient's global efficacy assessment and mean STRS scores both showed greater efficacy of Ibuprofen 25 mg over the 4-day treatment time, and, within participants with still clinically significant pain, after an average of 4 days. Ibuprofen 25 mg lozenge showed a safety profile comparable to placebo along with significant tolerability.
Rapid, well tolerated and effective relief to sore throat pain was seen among patients received Low-dose Ibuprofen 25 mg lozenge as compared to placebo.
Int J Clin Pract. 2017 Sep 4.
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
Bouroubi A et al.
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