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A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients with Osteoarthritis(OA)of the Shoulder, Elbow, Hip and Anlke(Japan. Phase III)

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Trial Profile

A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Repeated Intra-Articular Injection of SI-613 in Patients with Osteoarthritis(OA)of the Shoulder, Elbow, Hip and Anlke(Japan. Phase III)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 07 Dec 2021

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At a glance

  • Drugs Diclofenac-Eatlhyaluronate (Primary)
  • Indications Osteoarthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Ono Pharmaceutical; Seikagaku Corporation

Most Recent Events

  • 23 Mar 2021 According to an Ono Pharmaceutical media release, Seikagaku has obtained from the Ministry of Health, Labour and Welfare (MHLW) a manufacturing and marketing approval in Japan for JOYCLU 30mg Intra-articular Injection (diclofenac etalhyaluronate sodium; JOYCLU) for the indication of osteoarthritis (knee joint and hip joint).The approval is based on the results of three Phase III clinical studies conducted in Japan (JapicCTI173537,JapicCTI173678 and JapicCTI183855).
  • 06 Jan 2020 According to an Ono Pharmaceutical media release, company has submitted a new drug application ("NDA") for manufacturing and marketing approval for ONO-5704/SI-613 in Japan, for the treatment of osteoarthritis (knee joint, hip joint and ankle joint). The NDA is based on the results of three Phase III clinical studies conducted with the Product in Japan.
  • 06 Jan 2020 According to an Ono Pharmaceutical media release, primary endpoint (Daily pain diary) has been met.

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