Efficacy and safety of diclofenac–hyaluronate conjugate (diclofenac etalhyaluronate) for knee osteoarthritis: A randomized phase III trial in Japan

Arthritis & RheumatologyNishida Y, Kano K, Nobuoka Y, et al. | July 30, 2021

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This phase III multicenter, randomized, double-blind, placebo-controlled trial was conducted to corroborate that intraarticular (IA) injection of diclofenac covalently linked to hyaluronic acid (diclofenac etalhyaluronate [DF-HA]; ONO-5704/SI-613) is an efficacious as well as safe treatment option for patients suffering from knee osteoarthritis. A total of 440 participants received investigational products (220 were treated with placebo and 220 received DF-HA). A significant improvement in the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index version 3.1) pain subscale score was observed over 12 weeks among patients treated with DF-HA vs those given placebo. Anaphylactic reactions were noted.

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