Trial Profile

Sodium Risedronate 17.5 mg Tablets Special Drug Use Surveillance in Patients With Osseous Paget's Disease (All-case Surveillance) - 48-week Surveillance

Status: Completed

Phase of Trial: Phase IV

Latest Information Update: 07 Jan 2022

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At a glance

19 Mar 2020 According to a EA pharma co media release, announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has given notification of the results of reexamination to the effect that the all-case surveillance specified drug use-results survey condition required for the approval of Actonel 17.5 mg tablets (risedronate sodium hydrate) indicated for the treatment of Pagets disease of bone has been lifted. Based on safety data in 307 patients and efficacy data in 276 patients submitted to MHLW .
31 Jul 2017 Status changed from active, no longer recruiting to completed.
26 Jun 2017 Planned End Date changed from 1 Apr 2018 to 30 Apr 2018.

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