Conditions: Chemotherapy-Induced Nausea and Vomiting
Keywords: Highly emetogenic chemotherapy induced nausea and vomiting
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 68
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: 0.5 mg dose, intranasal powder, single spray, administered once arm 2: 1.0 mg dose, intranasal powder, songle spray, administered once arm 3: 2.0 mg dose, intranasal powder, single spray, administered once

Interventions: intervention 1: Intranasal granisetron
Intervention descriptions: intervention 1: 0.5 mg, 1.0 mg or 2.0 mg dose of TRG prior to the administration of a highly-emetogenic chemotherapy regimen

Protocol document: