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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01186029
Other study ID # 0359-09-FB
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2010
Est. completion date September 1, 2011

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is looking at whether the addition of Aprepitant (Emend), an antiemetic, will provide added efficacy if added to 2 drugs that are already used as a standard of care for post-operative nausea and vomiting and post-discharge nausea and vomiting.


Description:

This study is looking at whether the addition of a fairly new drug for the treatment of post-operative nausea and vomiting (PONV) and post-discharge nausea and vomiting (PDNV) will provide added efficacy if added to 2 drugs that are already used as a standard of care for PONV and PDNV. The patients that will be looked at will be deemed at higher risk for PONV and PDNV based on the procedure they are having done and/or on patient risk factors.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 1, 2011
Est. primary completion date September 1, 2011
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - patients with at least 2 of the common risk factors for PONV/PDNV; patients having a procedure deemed at high risk for PONV/PDNV Exclusion Criteria: - patients under 19 years of age; pregnant and breast-feeding patients

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
aprepitant
Emend 40mg by mouth 30 minutes before procedure x 1

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Outcome

Type Measure Description Time frame Safety issue
Primary EMEND Added to Standard Treatment of Post-operative and Post-Discharge Nausea and Vomiting To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen 1 year
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