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A Phase III Study of SI-613 in Patients with Knee Osteoarthritis (confirmatory study)

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Trial Profile

A Phase III Study of SI-613 in Patients with Knee Osteoarthritis (confirmatory study)

Status: Completed
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).
    • 22 Mar 2021 Status changed from active, no longer recruiting to completed according to results published in the Arthritis and Rheumatology.
    • 22 Mar 2021 Results published in the Arthritis and Rheumatology

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