Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

• Sponsor: University of Nebraska (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT01186029
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Duration (Months): 12
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Drug: aprepitant	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: A Comparison Study to Determine the Increased Efficacy of Adding EMEND to the Treatment Regimen for Post-Discharge and Post-Operative Nausea and Vomiting
• Study Start Date: Oct 1, 2010
• Anticipated Primary Completion Date: Jan 1, 2011
• Anticipated Study Completion Date: Oct 1, 2011

Outcome Measures

Primary Outcome Measures

1. To see if by adding EMEND to a standard treatment regimen for PONV/PDNV, added efficacy will be obtained. [1 year]

Secondary Outcome Measures

1. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

• University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maria Michaelis, MD, Principal Investigator, University of Nebraska
• ClinicalTrials.gov Identifier: NCT01186029
• Other Study ID Numbers: 359-09-FB
• First Posted: Aug 20, 2010
• Last Update Posted: Jan 31, 2018
• Last Verified: Jan 1, 2018

• Keywords provided by Maria Michaelis, MD, Principal Investigator, University of Nebraska: Looking at adding drug to already established treatment regimen for; Nausea and Vomiting
• Additional relevant MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting; Aprepitant

Study Results

No Results Posted as of Jan 31, 2018