Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

Trial Profile

Single-dose, Multicenter, Randomized, Double-blind, Double-dummy, Parallel Group Study to Assess the Efficacy and Safety of Oral Palonosetron 0.50 mg Compared to I.V. Palonosetron 0.25 mg Administered With Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Highly Emetogenic Cisplatin-based Chemotherapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Aug 2016

At a glance

  • Drugs Palonosetron (Primary) ; Palonosetron (Primary) ; Dexamethasone
  • Indications Chemotherapy-induced nausea and vomiting
  • Focus Registrational; Therapeutic Use
  • Sponsors Helsinn; Helsinn Healthcare SA
  • Most Recent Events

    • 15 Dec 2011 Additional trial location (Romania) identified as reported by ClinicalTrials.gov.
    • 23 Nov 2011 Additional locations added as reported by as reported by Clinical Trials Registry - India.
    • 23 Nov 2011 New source identified and integrated (Clinical Trials Registry - India record, CTRI2011-10-002073).
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