Phase 2 Study of Efficacy, Tolerability, and Safety of Intranasal Granisetron for Chemo-Induced Nausea and Vomiting
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
Summary
Brief Summary: A randomized, single administration, double-blind, parallel- group Phase 2
dose finding study to assess the efficacy, tolerability, and safety of TRG in patients with
chemotherapy-induced nausea and vomiting (CINV) associated with the administration of highly
emetogenic chemotherapy.
Primary Objective: To select a dose for Phase 3 by assessing the efficacy, safety, and
tolerability of 3 doses of TRG in patients with CINV associated with the administration of
highly emetogenic chemotherapy.