Phase 4
Completed N=181
Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
Source: ClinicalTrials.gov NCT00781768 ↗Enrolled (actual)
181
Serious AEs
3.9%
Results posted
Jul 2018
Primary outcomePrimary: Complete Response Rates Among Standard of Care and Combination Therapy Groups. — 58; 73; 31; 17 Participants — p=<.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rates Among Standard of Care and Combination Therapy Groups. |
58; 73; 31; 17 | <.001 sig |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of cancer, admitted for myelosupppresive stem cell transplantation. Included preparative regimens include: TBI/VP16/CY, TBI/CY, BU/CY (PO & IV), and BCV
- Age 18 or older
- Alcohol intake 100 gm/d in the last year]
- Allergy or intolerance to: ondansetron or dexamethasone
- Renal dysfunction [measured or estimated CrCl 1.5, AST > 2x ULN, unless due to disease]
- Inability to swallow tablets or capsules
- Concurrent condition requiring systemic steroid use
- Nonmyeloablative SCT, patients receiving the conditioning regimens not included [see inclusion criteria]
- History of anticipatory nausea and vomiting
Data sourced from ClinicalTrials.gov (NCT00781768). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.