A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients
Phase 3
12 Years
17 Years
12 Years
17 Years
Not Enrolling
Both
Vomiting
Both
Vomiting
Trial Information
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated With Emetogenic Chemotherapy in Adolescent Patients
The duration of treatment is 4 days, up to 10 cycles.
Inclusion Criteria
Patient is to be treated with an emetogenic chemotherapy regimen that includes either
cisplatin, cyclophosphamide, or carboplatin, for a documented solid malignancy, for
either 1 day or 2 consecutive days OR Patient did not tolerate a previously administered
chemotherapy regimen, for a documented solid malignancy, secondary to nausea and/or
vomiting that is planned to be repeated.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Drug-related adverse experiences
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Merck
Authority:
United States: Food and Drug Administration
Study ID:
2004_099
NCT ID:
NCT00080444
Start Date:
April 2004
Completion Date:
March 2007
Related Keywords:
- Vomiting
- Vomiting
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