Phase 4 N=181 Randomized Quadruple-blind Treatment

Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea

Nausea · Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT00781768 ↗

Enrolled (actual)

181

Serious AEs

3.9%

Results posted

Jul 2018

Primary outcome: Primary: Complete Response Rates Among Standard of Care and Combination Therapy Groups. — 58; 73; 31; 17 Participants — p=<.001

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Standard PO (Zofran + Dexamethason) (Drug); Aprepitant (MK-869) + Standard PO (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Loyola University
Primary completion: Oct 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Response Rates Among Standard of Care and Combination Therapy Groups.	58; 73; 31; 17	<.001 sig

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.

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

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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.