biostudies-literatureUnknown60(1)Ishiguro NOno Pharmaceutical Co., LtdWe examined the efficacy, safety, and tolerability of ONO-4474 in Japanese patients with osteoarthritis (OA) of the knee. In this multicenter, placebo-controlled, randomized, double-blind, parallel-group comparative study, patients with moderate to severe OA who were refractory to nonsteroidal anti-inflammatory drugs were orally administered 100 mg of ONO-4474 twice daily for 28 days. The primary end point was knee pain during walking, assessed by visual analog scale over 24 hours (VAS₂₄ ). Treatment-emergent adverse events (TEAEs) and adverse drug reactions were reported for safety. In total, 110 patients were randomized (1:1) to receive placebo or ONO-4474. The mean (standard deviation) change in VAS₂₄ scores at week 4 was -26.9 (25.0) mm in the ONO-4474 group and -Journal of clinical pharmacology28-36https://www.ebi.ac.uk/biostudies/studies/S-EPMC6973102biostudies-literatureEfficacy, Safety, and Tolerability of ONO-4474, an Orally Available Pan-Tropomyosin Receptor Kinase Inhibitor, in Japanese Patients With Moderate to Severe Osteoarthritis of the Knee: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Study.PMC6973102Ishiguro NYanagida KHigashi ROyama SfalseEfficacy, Safety, and Tolerability of ONO-4474, an Orally Available Pan-Tropomyosin Receptor Kinase Inhibitor, in Japanese Patients With Moderate to Severe Osteoarthritis of the Knee: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Study.We examined the efficacy, safety, and tolerability of ONO-4474 in Japanese patients with osteoarthritis (OA) of the knee. In this multicenter, placebo-controlled, randomized, double-blind, parallel-group comparative study, patients with moderate to severe OA who were refractory to nonsteroidal anti-inflammatory drugs were orally administered 100 mg of ONO-4474 twice daily for 28 days. The primary end point was knee pain during walking, assessed by visual analog scale over 24 hours (VAS₂₄ ). Treatment-emergent adverse events (TEAEs) and adverse drug reactions were reported for safety. In total, 110 patients were randomized (1:1) to receive placebo or ONO-4474. The mean (standard deviation) change in VAS₂₄ scores at week 4 was -26.9 (25.0) mm in the ONO-4474 group and -2020-01-01T00:00:00Z2020 Jan2025-04-05T00:13:11.643Z2020-05-22T08:56:28ZS-EPMC69731023128198810.1002/jcph.1470