Aprepitant
DrugDay 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg
NCT Number: NCT00952341
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Cycle 1:
Cycle 2 (optional):
appropriate by the investigator and will not pose unwarranted risk to the patient.
study procedures.
dose is still no less than 70 mg/m^2.
Exclusion criteria
Cycles 1 & 2:
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
Time frame: 0 to 120 hours
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 24 hours
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: 25 to 120 hours
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: 0 to 120 hours
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 24 hours
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy.
Time frame: 25 to 120 hours
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy
Time frame: 0 to 120 hours
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 from administration of chemotherapy to first vomiting episode.
Merck Sharp & Dohme LLC
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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