Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00952133
First received: July 30, 2009
Last updated: February 13, 2014
Last verified: February 2014
Results First Received: June 22, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: PONV
Interventions: Drug: Placebo Comparator
Drug: Palonosetron with Dexamethasone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment from July 2010 until December 2011 in pre-surgical clinic and in same day surgery.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Palonosetron With Dexamethasone Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 5mg IV Dexamethasone (Decadron) before surgery.
Palonosetron With Placebo Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution

Participant Flow:   Overall Study
    Palonosetron With Dexamethasone     Palonosetron With Placebo  
STARTED     59     59  
COMPLETED     59     59  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Palonosetron With Dexamethasone Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 5mg IV Dexamethasone (Decadron) before surgery.
Palonosetron Only Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
Total Total of all reporting groups

Baseline Measures
    Palonosetron With Dexamethasone     Palonosetron Only     Total  
Number of Participants  
[units: participants]
  59     59     118  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     59     59     118  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  35.2  ± 8.8     36.2  ± 8.1     35.7  ± 8.4  
Gender  
[units: participants]
     
Female     48     52     100  
Male     11     7     18  
Region of Enrollment  
[units: participants]
     
United States     59     59     118  



  Outcome Measures
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1.  Primary:   Complet Response Rate   [ Time Frame: Pre-op through 72 hours post emergence from anesthesia ]

2.  Secondary:   Number of Participants Who Experienced no or Reduced PONV the First 96 Hours After Surgery   [ Time Frame: Pre-op through 96 hours post-op ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
None.  


Results Point of Contact:  
Name/Title: Jeanna Blitz, MD
Organization: NYU Langone Medical Center
phone: 212-263 ext 0667
e-mail: jeanna.viola@nyumc.org


Publications of Results:

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00952133     History of Changes
Other Study ID Numbers: H08-605
Study First Received: July 30, 2009
Results First Received: June 22, 2012
Last Updated: February 13, 2014
Health Authority: United States: Institutional Review Board