To Assess the Efficacy and Safety of Ramosetron, Aprepitant and Dexamethasone Therapy vs Ondansetron, Aprepitant and Dexamethasone Therapy for Preventing of Nausea and Vomiting in Highly Emetogenic Chemotherapy (ROAD Study)

NCT01536691 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Hallym University Medical Center
Phase	Phase 3
Status	UNKNOWN
Enrolment	338
Start date	2011-06
Completion	2013-02

Conditions

• Cancer
• Malignancy

Interventions

• ramosetron
• ondansetron

Primary outcomes

• complete response (CR) — acute phase (within 24 hrs after onset of chemotherapy)
  CR means no vomiting \& no rescue medication

Countries

South Korea