Last updated: 11/03/2018 16:10:52

Relenza® Sentinel Site Monitoring Program in JapanSSMP

GSK study ID
114045
See study documents
Clinicaltrials.gov ID
NCT01199744
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Collection of Patients' Background InformationRelenza® Sentinel Site Monitoring Program in Japan
Trial description: To collect background information of patients receiving a prescription for Relenza® and study risk factors etc. for adverse drug reactions collected through spontaneous reporting. In particular, to characterize the types and incidences of adverse events, serious adverse events, and adverse drug reactions and to investigate risk factors for them in patient populations that are regarded to be at high risk for novel influenza A (H1N1)and in which the use experience of Relenza® has not been enough (such as pregnant women, infants, elderly persons, and those with decreased physical function) in accordance with the PFSB/SD Notification 0904, No.2 of the Safety Division, Pharmaceutical and Food Safety Bureau, MHLW, dated 4th September 2009.
To compare the data with the safety data collected in overseas sentinel site monitoring programs.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with any adverse drug reaction

Timeframe: 5 months (November 2009 to March 2010)

Secondary outcomes:

Number of participants with any serious adverse drug reaction (ADR)

Timeframe: 5 months (November 2009 to March 2010)

Number of male and female participants with either a serious or non-serious adverse drug reaction

Timeframe: 5 months (November 2009 to March 2010)

Number of participants in the indicated age categories with either a serious or non-serious adverse drug reaction

Timeframe: 5 months (November 2009 to March 2010)

Number of participants with either a serious or non-serious adverse drug reaction categorized by reason for the use of Relenza

Timeframe: 5 months (November 2009 to March 2010)

Number of participants with either a serious or non-serious adverse drug reaction categorized by either having complications or having no complications

Timeframe: 5 months (November 2009 to March 2010)

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

Timeframe: 5 months (November 2009 to March 2010)

Number of participants with either a serious or non-serious adverse drug reaction who were also in the indicated high-risk categories

Timeframe: 5 months (November 2009 to March 2010)

Number of participants with either a serious or non-serious adverse drug reaction who were vaccinated for influenza

Timeframe: 5 months (November 2009 to March 2010)

Number of participants with either a serious or non-serious adverse drug reaction who were also taking concomitant medications

Timeframe: 5 months (November 2009 to March 2010)

Interventions:
  • Drug: zanamivir
    • Enrollment:
    1575
    Primary completion date:
    2010-16-04
    Observational study model:
    Other
    Time perspective:
    Prospective
    Clinical publications:
    Medicine and Drug Journal Vol.46 No.12 p.136-142, 2010
    Daisuke Tashiro, Norio Sugaya. Impact of the new drugs of treatment for H1N1 2009 influenza virus. [Medicine and Drug Journal]. 2010;46(2):756-759.
    Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Evaluation of Prophylactic Effects of Zanamivir (Relenza®) for Influenza - from Results of Post-Marketing Surveillance on Relenza® -. [Medicine and Drug Journal]. 2010;46(11):2747-2758.
    Medical condition
    Influenza, Human
    Product
    zanamivir
    Collaborators
    Not applicable
    Study date(s)
    November 2009 to April 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza
    • N/A
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza
    Exclusion criteria:
    • N/A

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-16-04
    Actual study completion date
    2010-16-04

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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