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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
421
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
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0 to 120 hours
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Time frame: 0 to 24 hours
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
Time frame: 25 to 120 hours
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy. No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).
Time frame: 0 to 120 hours
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
Time frame: 0 to 24 hours
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
Time frame: 25 to 120 hours
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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
Proportion of Participants With No Impact on Daily Life in Cycle 1
The Functional Living Index-Emesis is a self-administered, validated emesis \& nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea \& vomiting (CINV) on daily life" was defined as an average item score of \>6 on the 7-point scale (i.e., \>108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 \& 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).
Time frame: 0 to 120 hours
Time to First Vomiting Episode in Cycle 1
Time from administration of chemotherapy to first vomiting episode.
Time frame: 0 to 120 hours