At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin
In Brief
A Phase 3 clinical trial evaluating aprepitant, Comparator: Placebo to aprepitant, and 2 other interventions for Chemotherapy-induced Nausea and Vomiting (CINV). Completed, enrolled 421 participants.
Detailed Summary
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
Study Details
Timeline
Interventions
Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg
Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg
Day 1: IV granisetron 3 mg prior to administration of cisplatin
Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg