drugset / Trial / NCT01536691
Ramosetron, Aprepitant and Dexamethasone Versus Ondansetron, Aprepitant and Dexamethasone
Phase 3
Unknown
338 enrolled
Hallym University Medical Center
Astellas Pharma Korea, Inc. · collabKorean Cancer Study Group · collab
RandomizedParallel-groupSingle-blindSupportive care
Summary
The purpose of this study is to assess the efficacy and safety of Ramosetron, Aprepitant and Dexamethasone therapy versus Ondansetron, Aprepitant and Dexamethasone therapy for preventing of nausea and vomiting in highly emetogenic chemotherapy (ROAD study): Prospective multicenter, randomized, single blinded, phase III study.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-11
- Completion
- 2013-02
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ondansetron | Other / unclassified | 16 mg | Intravenous |
| Subject | Ramosetron | Small molecule | 0.3 mg | Intravenous |
| Background | Aprepitant | Other / unclassified | 80 mg | Oral |
| Background | Dexamethasone | Small molecule | 8 mg | Oral |