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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
  Purpose

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 Intervention
Postoperative Nausea and Vomiting
Drug: aprepitant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: October 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: aprepitant
    Emend 40mg by mouth 30 minutes before procedure x 1
    Other Name: EMEND
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186029

Locations
United States, Nebraska
University of Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Contact: Maria A. Michaelis, M.D.    402-559-4081    mamichaelis@unmc.edu   
Sponsors and Collaborators
University of Nebraska
  More Information

No publications provided

Responsible Party: Maria A. Michaelis, M.D., University of Nebraska Medical Center
ClinicalTrials.gov Identifier: NCT01186029     History of Changes
Other Study ID Numbers: 359-09-FB
Study First Received: August 19, 2010
Last Updated: August 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
Looking at adding drug to already established treatment regimen for
Nausea and Vomiting

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on November 27, 2014