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

PHASE4CompletedINTERVENTIONAL
Enrollment

181

Participants

Timeline

Start Date

August 31, 2003

Primary Completion Date

October 31, 2008

Study Completion Date

July 31, 2010

Conditions
NauseaVomiting
Interventions
DRUG

Standard PO (Zofran + Dexamethason)

Dexamethasone 10 mg (dose blinded) in 50 ml D5W IVPB over 15 minutes daily + ondansetron 8mg PO q 8 hours - repeated qd of the preparative regimen and for 1 day after completion. A placebo capsule will be given daily on each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

DRUG

Aprepitant (MK-869) + Standard PO

Dexamethasone 7.5 mg (dose blinded) in 50 ml D5W IVPB over 15 min daily + ondansetron 8mg PO q 8 hours - repeated QD of the preparative regimen and for 1 day after completion. Aprepitant 125mg PO \[blinded\] will be given a minimum of 30 minutes prior to the preparative regimen on day 1. MK-Aprepitant 80mg PO \[blinded\] will be given will be given approximately 24 hours later starting on day 2 then each day of the preparative regimen plus 3 days after. Antiemetic therapy will start a minimum of 30 minutes prior to and continued for 24 hours after completion of the preparative regimen.

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Loyola University

OTHER

NCT00781768 - Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea | Biotech Hunter | Biotech Hunter