A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy (EASE)

NCT00619359 Phase 3 COMPLETED Results posted

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

Details

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 3
Status	COMPLETED
Enrolment	2322
Start date	2008-02
Completion	2009-06

Conditions

• Chemotherapy-Induced Nausea and Vomiting (CINV)

Interventions

• Comparator: fosaprepitant dimeglumine
• Comparator: Aprepitant
• Dexamethasone
• Dexamethasone
• Ondansetron

Primary outcomes

• A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). — Overall (in the 120 hours following initiation of cisplatin chemotherapy).
  The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.