Sun-Novo(SH:688621) Xin Lang Cai Jing·2025-11-26 04:40Core Points - The clinical trial for Ketoprofen gel patch, aimed at alleviating knee osteoarthritis pain, has been initiated by Beijing Sunshine Novo Pharmaceutical Research Co., Ltd. and Beijing Bai'ao Pharmaceutical Co., Ltd. [1] - The trial is a multicenter, randomized, positive drug and placebo-controlled Phase III study, with a registration number of CTR20254424, first published on November 24, 2025 [1]. - The primary endpoint of the trial is the change in VAS pain score (walking) on day 29 compared to baseline, with secondary endpoints including VAS pain scores on days 15 and 22, as well as modified WOMAC scores [1]. Summary by Sections Clinical Trial Details - The trial is currently ongoing and has not yet recruited participants, with a target enrollment of 420 individuals [2]. - The drug is administered as a patch, with a dosage of one patch twice daily for four consecutive weeks [1]. Drug Information - Ketoprofen gel patch is a chemical drug indicated for knee osteoarthritis, characterized by symptoms such as knee pain, swelling, and stiffness [1]. - Diagnosis relies on symptoms, physical examination, and imaging studies like X-rays and CT scans [1]. Evaluation Metrics - The trial will evaluate the efficacy of the drug against placebo and a positive control, as well as assess the safety of the drug [1]. - Key metrics include changes in pain scores and overall functionality as measured by the WOMAC scale [1].