Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2010 by University of Nebraska.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

University of Nebraska

ClinicalTrials.gov Identifier:

NCT01186029

First received: August 19, 2010

Last updated: NA

Last verified: August 2010

History: No changes posted

Tracking Information
First Received Date ^ICMJE	August 19, 2010
Last Updated Date	August 19, 2010
Start Date ^ICMJE	October 2010
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 19, 2010)	To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: August 19, 2010)	To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Comparison of Adding EMEND to PONV/PDNV Treatment Regimen
Official Title ^ICMJE	A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention
Condition ^ICMJE	Postoperative Nausea and Vomiting
Intervention ^ICMJE	Drug: aprepitant Emend 40mg by mouth 30 minutes before procedure x 1 Other Name: EMEND
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	300
Estimated Completion Date	October 2011
Estimated Primary Completion Date	October 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01186029
Other Study ID Numbers ^ICMJE	359-09-FB
Has Data Monitoring Committee	Yes
Responsible Party	Maria A. Michaelis, M.D., University of Nebraska Medical Center
Study Sponsor ^ICMJE	University of Nebraska
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Nebraska
Verification Date	August 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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