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

August 19, 2010
August 19, 2010
October 2010
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Comparison of Adding EMEND to PONV/PDNV Treatment Regimen
A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Postoperative Nausea and Vomiting
Drug: aprepitant
Emend 40mg by mouth 30 minutes before procedure x 1
Other Name: EMEND
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
United States
 
NCT01186029
359-09-FB
Yes
Maria A. Michaelis, M.D., University of Nebraska Medical Center
University of Nebraska
Not Provided
Not Provided
University of Nebraska
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP