Phase 3 Study of Pelubiprofen & Loxoprofen in Patients With Upper Respiratory Tract Infection

Summary

Multi-center, Randomized, Double blind, Controlled Parallel-group Comparative Phase 3 Clinical trial to assess the efficacy and safety of Pelubiprofen Compared to Loxoprofen in patients with Acute upper respiratory infection.

Timeline

Start

2013-01

Primary completion

2016-03

Completion

—

Outcome

Met primary endpoint

paper The lower bound of the 97.5% one-sided confidence interval was -0.30 °C, which is greater than the non-inferiority margin of 0.35 °C. PMID 40094866 ↗

Publications

• Jang AS, Kim SH, Lee SP, Na MJ, Yoo KH, Park CH, Park SY, Choi BW. 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. J Clin Med. 2025 Feb 21;14(5):1450. doi: 10.3390/jcm14051450.

Drugs

Indications