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Efficacy of IV Palo With IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed PONV (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: March 30, 2015
Last verified: March 2015
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: Palonosetron only
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
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 8mg 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 8mg 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 
Overall Participants Analyzed 
[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:   Complete Response Rate   [ Time Frame: Pre-op through 72 hours post emergence from anesthesia ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  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.


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: March 30, 2015
Health Authority: United States: Institutional Review Board