Last updated: 11/03/2018 12:51:47
Special Drug Use Investigation for Relenza® (zanamivir) (Prophylaxis)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Special Drug Use Investigation for Relenza® (zanamivir) (Prophylaxis)
Trial description: The purpose of this post-marketing surveillance study is to collect information on efficacy and safety for prophylactic administration of zanamivir in clinical practice in family or persons living with patients with influenza virus infection.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
The number of incidence of adverse events in subjects treated with zanamivir
Timeframe: 11 days
Occurrence of influenza virus infection
Timeframe: 11 days
Secondary outcomes:
Not applicable
Interventions:
Drug: Zanamivir hydrate
Enrollment:
622
Observational study model:
Other
Primary completion date:
Not applicable
Time perspective:
Prospective
Clinical publications:
Keizo Matsumoto, Hideyuki Okano, Naomi Hasegawa, Ichiro Ohwaki, Shogo Inoshiri. Study on Preventive Effects of Zanamivir (Relenza) for Influenza. Medicine and Drug Journal. 2010;46(11):121-132.
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® -. 2010;46(11):2747-2758.
Medical condition
Influenza, Human
Product
zanamivir
Collaborators
Not applicable
Study date(s)
January 2007 to May 2009
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable+ years
Accepts healthy volunteers
None
- Subjects who meet the study population criteria
- Subjects with a history of hypersensitivity to the ingredients of zanamivir
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who meet the study population criteria
Exclusion criteria:
- Subjects with a history of hypersensitivity to the ingredients of zanamivir
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
Not applicable
Actual study completion date
2009-20-05
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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