Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
Summary
The purpose of this study is to compare two different treatment protocols for treating nausea and vomiting in patients who have undergone bone marrow transplant. Patients will be assigned to one of two treatment groups. The first group will recieve ondansetron (Zofran) tablets combined with a medicine called dexamethasone given IV. Both of these drugs are commercially available. Patients in the second treatment consists of the first two drugs, plus a newly approved drug known as aprepitant (MK-869, Emend). This combination will be the treatment being tested. The combination is approved by the FDA for chemotherapy regimens known to cause a lot of nausea and vomiting. It significantly decreases the delayed (more than 24 hours after therapy) nausea and vomiting seen with these regimens.
Timeline
- Start
- 2003-08
- Primary completion
- 2008-10
- Completion
- 2010-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aprepitant | Other / unclassified | 80 mg | Oral |
| Comparator | Dexamethasone | Small molecule | 7.5 mg | Intravenous |
| Comparator | Dexamethasone | Small molecule | 10 mg | Intravenous |
| Comparator | Aprepitant (MK-869) + Standard PO | Unknown | 8 mg | — |
| Comparator | Ondansetron | Other / unclassified | 8 mg | Oral |
Indications
No indication recorded.