drugset / Trial / NCT00080444
Study of Aprepitant (MK-0869) for Chemotherapy-Induced Nausea and Vomiting (CINV) in Adolescent Participants (MK-0869-097)
RandomizedParallel-groupTriple-blindPrevention
Summary
This study is being conducted to demonstrate that aprepitant (MK-0869) prevents nausea and vomiting caused by emetogenic cancer chemotherapy in adolescent participants. Participants treated with emetogenic cancer chemotherapies that include either cisplatin, cyclophosphamide, or carboplatin, or participants who experienced nausea and/or vomiting when treated with a previously administered chemotherapy regimen that is planned to be repeated will be enrolled in this study. In the double-blind Part 1 of this study, enrolled participants will be randomized to receive either aprepitant or standard therapy. In Part 2 of this study, enrolled participants will receive open-label aprepitant.
Timeline
- Start
- 2004-04
- Primary completion
- 2006-09
- Completion
- 2007-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aprepitant | Other / unclassified | 80 mg | Oral |
| Subject | Dexamethasone | Small molecule | 4 mg | Oral |
| Subject | Dexamethasone | Small molecule | 8 mg | Oral |
| Background | Ondansetron | Other / unclassified | 0.15 mg/kg | Intravenous |
Indications
No indication recorded.