Last updated: 11/03/2018 16:10:52
Relenza® Sentinel Site Monitoring Program in JapanSSMP
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2010-16-04
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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