A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Nausea, Vomiting
Both
Nausea, Vomiting
Trial Information
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Safety, Tolerability and Efficacy of Aprepitant Regimen Compared to Ondansetron Regimen for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With High Dose Cisplatin in Cycle 1
Inclusion Criteria:
- Patient is greater than 18 years of age.
- Patient is scheduled to receive his/her first course of cisplatin chemotherapy for a
solid tumor.
- Patient has a prognosis (life expectancy) greater than or equal to 3 months.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Patient vomiting
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
2004_005
NCT ID:
NCT00090207
Start Date:
January 2004
Completion Date:
Related Keywords:
- Nausea
- Vomiting
- Nausea
- Vomiting
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