{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,13]],"date-time":"2026-03-13T15:43:15Z","timestamp":1773416595925,"version":"3.50.1"},"reference-count":8,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T00:00:00Z","timestamp":1740096000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Daewon Pharmaceutical Co., Ltd., Seoul, Republic of Korea"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCM"],"abstract":"<jats:p>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 (\u226538.0 \u00b0C), who were randomly assigned to receive pelubiprofen or loxoprofen at a 1:1 ratio. The primary end point was decreasing axillary temperature 4 h post-dose. Secondary end points included fever reduction, pain relief based on the visual analog scale (VAS), and safety. Results: Of the 181 participants, 130 (pelubiprofen [n = 61] and loxoprofen group [n = 69]) underwent randomization. The mean reduction in axillary temperature at 4 h post-dose was comparable between the two groups (\u22120.08 \u00b1 0.62 \u00b0C). The lower bound of the 97.5% one-sided confidence interval was \u22120.30 \u00b0C, which is greater than the non-inferiority margin of 0.35 \u00b0C, demonstrating the non-inferiority of pelubiprofen to loxoprofen. The secondary outcomes showed no significant differences in efficacy or safety (p &gt; 0.05). Conclusions: Pelubiprofen is not inferior to loxoprofen in reducing fever associated with URTIs and is a safe and effective treatment option. Registration: (ClinicalTrials.gov identifier: NCT01779271).<\/jats:p>","DOI":"10.3390\/jcm14051450","type":"journal-article","created":{"date-parts":[[2025,2,21]],"date-time":"2025-02-21T06:39:07Z","timestamp":1740119947000},"page":"1450","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["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"],"prefix":"10.3390","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5343-023X","authenticated-orcid":false,"given":"An Soo","family":"Jang","sequence":"first","affiliation":[{"name":"Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon 14584, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Hoon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Eulji University School of Medicine, Nowon Eulji University, Seoul 01830, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Pyo","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Gachon University Gil Medical Center, Incheon 21565, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Moon Jun","family":"Na","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Konyang University Hospital, Daejeon 35365, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwang Ha","family":"Yoo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Konkuk University Medical Center, Seoul 05030, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang Han","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Sungae Hospital, Seoul 07354, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Seong Yeon","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Dongguk University Ilsan Hospital, Goyang 10326, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7196-4075","authenticated-orcid":false,"given":"Byoung Whui","family":"Choi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Soha Healthcare Center, Chung-Ang University Gwangmyeong Hospital, Gwangmyeong 14353, Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"1968","published-online":{"date-parts":[[2025,2,21]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"718","DOI":"10.1016\/S1473-3099(05)70270-X","article-title":"Understanding the symptoms of the common cold and influenza","volume":"5","author":"Eccles","year":"2005","journal-title":"Lancet Infect. 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Clin. Pharmacol."}],"container-title":["Journal of Clinical Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/5\/1450\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,9]],"date-time":"2025-10-09T16:39:40Z","timestamp":1760027980000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2077-0383\/14\/5\/1450"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,21]]},"references-count":8,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2025,3]]}},"alternative-id":["jcm14051450"],"URL":"https:\/\/doi.org\/10.3390\/jcm14051450","relation":{},"ISSN":["2077-0383"],"issn-type":[{"value":"2077-0383","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,21]]}}}