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Relenza® Sentinel Site Monitoring Program in Japan (SSMP)

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01199744
First received: September 9, 2010
Last updated: November 17, 2011
Last verified: November 2011
History of Changes
Results First Received: March 17, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Influenza, Human
Intervention: Drug: zanamivir

  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
This Sentinel Site Monitoring Program collected the patient background and safety data of Relenza administered in the Japanese population per the requirements of the Japanese Ministry of Health, Labour and Welfare (MHLW).

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
Relenza Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.

Participant Flow:   Overall Study
    Relenza  
STARTED     1575  
COMPLETED     1575  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Relenza Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.

Baseline Measures
    Relenza  
Number of Participants  
[units: participants]
 		  1575  
Age, Customized  
[units: participants]
 		 
>=3 to <7 years     195  
>=7 to <15 years     790  
>=15 to <65 years     586  
>=65 to <74 years     4  
Gender  
[units: Participants]
 		 
Female     827  
Male     748  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Any Adverse Drug Reaction   [ Time Frame: 5 months (November 2009 to March 2010) ]
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2.  Secondary:   Number of Participants With Any Serious Adverse Drug Reaction (ADR)   [ Time Frame: 5 months (November 2009 to March 2010) ]
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3.  Secondary:   Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction   [ Time Frame: 5 months (November 2009 to March 2010) ]
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4.  Secondary:   Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction   [ Time Frame: 5 months (November 2009 to March 2010) ]
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5.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza   [ Time Frame: 5 months (November 2009 to March 2010) ]
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6.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications   [ Time Frame: 5 months (November 2009 to March 2010) ]
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7.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Risk Factors for Influenza or Having no Risk Factors   [ Time Frame: 5 months (November 2009 to March 2010) ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories   [ Time Frame: 5 months (November 2009 to March 2010) ]
  Show Outcome Measure 8

9.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza   [ Time Frame: 5 months (November 2009 to March 2010) ]
  Show Outcome Measure 9

10.  Secondary:   Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications   [ Time Frame: 5 months (November 2009 to March 2010) ]
  Show Outcome Measure 10


  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: NCT01199744     History of Changes
Other Study ID Numbers: 114045
Study First Received: September 9, 2010
Results First Received: March 17, 2011
Last Updated: November 17, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare