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ULTIVA Post Marketing Surveillance

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01299584
First received: February 17, 2011
Last updated: March 24, 2011
Last verified: February 2011
History of Changes
Results First Received: March 24, 2011  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Analgesia
Intervention: Drug: Remifentanil

  Participant Flow
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  Baseline Characteristics
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Reporting Groups
  Description
Ultiva 1, 2, or 3 mg One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.

Baseline Measures
    Ultiva 1, 2, or 3 mg  
Number of Participants  
[units: participants]
 		  766  
Age [1]
[units: Years]
Mean ± Standard Deviation 		  45.3  ± 16.5  
Gender [2]
[units: Participants]
 		 
Female     422  
Male     343  
Race/Ethnicity, Customized [1]
[units: participants]
 		 
Korean     766  
Not Korean     0  
[1] Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments.
[2] Baseline characteristics were collected in members of the Intent-to-Treat (ITT) Population, comprised of all participants who had been administered the investigational drug at least once and had undergone all safety assessments. Gender data are missing for one participant.



  Outcome Measures
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1.  Primary:   Number of Participants With an Unexpected Serious Adverse Event   [ Time Frame: 24 hours ]
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2.  Secondary:   Number of Participants With an Adverse Event   [ Time Frame: 24 hours ]
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3.  Secondary:   Number of Participants With a Serious Adverse Event   [ Time Frame: 24 hours ]
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4.  Secondary:   Number of Participants With the Indicated Unexpected Adverse Event   [ Time Frame: 24 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided


Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01299584     History of Changes
Other Study ID Numbers: 105936
Study First Received: February 17, 2011
Results First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: Korea: Korea Food & Drug Administration