A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Nausea, Vomiting, Breast Neoplasms
Both
Nausea, Vomiting, Breast Neoplasms
Trial Information
A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Moderately Emetogenic Chemotherapy
Inclusion Criteria:
- Patient with a diagnosis of breast cancer requiring treatment with non-cisplatin
moderately emetogenic chemotherapy.
Exclusion Criteria:
- Patient has a central nervous system malignancy.
- Patient will receive radiation to the abdomen or pelvis.
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:
Emesis and use of rescue medication
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_063
NCT ID:
NCT00092183
Start Date:
October 2002
Completion Date:
February 2004
Related Keywords:
- Nausea
- Vomiting
- Breast Neoplasms
- Chemotherapy-Induced Nausea and Vomiting
- Breast Neoplasms
- Neoplasms
- Nausea
- Vomiting
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