Status:
COMPLETED
Odansetron and Dexamethasone Alone vs. Odansetron, Dexamethason and Apreptant to Prevent Nausea
Lead Sponsor:
Loyola University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 tw...
Detailed Description
This will be a single center, comparative, randomized, double-blind, phase III trial designed to evaluate the efficacy of the NK-1 antagonist, aprepitant (MK-869), in combination with ondansetron and ...
Eligibility Criteria
Inclusion
- 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 for the last year (\< approximately 5 drinks per day)
- Renal function: estimated or measured CrCl 50 ml/min
- Liver function: T.Bili \<1.5, AST \< 2x ULN, unless due to disease
- Able to swallow tablets and capsules
Exclusion
- Age \< 18
- High alcohol intake \[\> 100 gm/d in the last year\]
- Allergy or intolerance to: ondansetron or dexamethasone
- Renal dysfunction \[measured or estimated CrCl \< 50 ml/min\]
- Liver dysfunction \[T.Bili \> 1.5, AST \> 2x ULN, unless due to disease\]
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
181 Patients enrolled
Trial Details
Trial ID
NCT00781768
Start Date
August 1 2003
End Date
July 1 2010
Last Update
July 27 2018
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