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A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation

Trial Profile

A Phase III Study of SI-6603 in Patients with Lumbar Disc Herniation

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Dec 2018

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At a glance

  • Drugs Condoliase (Primary)
  • Indications Intervertebral disc displacement
  • Focus Registrational; Therapeutic Use
  • Sponsors Seikagaku Corporation
  • Most Recent Events

    • 23 Mar 2018 Based on the data from this trial, the Japanese Ministry of Health, Labour and Welfare ("MHLW") has approved the New Drug Application ("NDA") of HERNICORE 1.25 units for intradiscal injection in Japan, indicated for the treatment of lumbar disc herniation.
    • 18 Sep 2014 Status changed from active, no longer recruiting to completed as reported by University Hospital Medical Information Network - Japan
    • 05 Jun 2014 According to the Seikagaku Corporation media release, results from this trial presented at the 41st Annual Meeting of the International Society for the Study of the Lumbar Spine on 4 June 2014.
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