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A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy

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Trial Profile

A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Mar 2019

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At a glance

  • Drugs Granisetron (Primary) ; Granisetron (Primary)
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Solasia Pharma
  • Most Recent Events

    • 24 Jul 2018 According to a Solasia Pharma media release, the China National Drug Administration (CNDA) approved Sancuso (Granisetron Transdermal System) for the prevention of chemotherapy-induced nausea and vomiting (CINV).
    • 11 Apr 2014 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 10 Sep 2013 New source identified and integrated: ClinicalTrials.gov record.
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