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Comparison of Adding EMEND to PONV/PDNV Treatment Regimen

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ClinicalTrials.gov Identifier: NCT01186029
Recruitment Status : Withdrawn (It didn't get IRB approval.)
First Posted : August 20, 2010
Last Update Posted : January 31, 2018
Sponsor:
Information provided by (Responsible Party):
Maria Michaelis, MD, University of Nebraska

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : October 2010
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: aprepitant
    Emend 40mg by mouth 30 minutes before procedure x 1
    Other Name: EMEND


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

Secondary Outcome Measures :
  1. To see if there is more efficacy for PONV vs. PDNV by adding EMEND to the treatment regimen [ Time Frame: 1 year ]


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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186029


Locations
United States, Nebraska
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska

Responsible Party: Maria Michaelis, MD, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01186029     History of Changes
Other Study ID Numbers: 359-09-FB
First Posted: August 20, 2010    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Keywords provided by Maria Michaelis, MD, 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
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action