The Efficacy and Safety of Pelubiprofen in the Treatment of Acute Upper Respiratory Tract Infection: A Multicenter, Randomized, Double-Blind, Non-Inferiority Phase III Clinical Trial Compared to Loxoprofen.

ABSTRACT: Background/Objectives: Acute upper respiratory tract infections (URTIs) are common illnesses that cause significant discomfort due to symptoms such as fever, headache, sore throat, and muscle pain. Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for symptom relief due to their anti-inflammatory, analgesic, and antipyretic properties. Pelubiprofen, a new NSAID, has not been extensively evaluated for its efficacy and safety in treating URTI-related symptoms, particularly fever. This study aimed to demonstrate that pelubiprofen is not inferior to loxoprofen in reducing fever in patients with URTIs. Methods: This phase III, multicenter, randomized, double-blind, parallel-group, active-controlled, non-inferiority trial involved 181 adults with URTI-related fever (≥3

SUBMITTER: Jang AS 

PROVIDER: S-EPMC11901028 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature