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Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

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ClinicalTrials.gov Identifier: NCT01390792
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : May 16, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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.

Condition or disease Intervention/treatment
Influenza, Human Drug: Zanamivir hydrate

Study Type : Observational
Actual Enrollment : 622 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)
Study Start Date : January 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Zanamivir
U.S. FDA Resources

Group/Cohort Intervention/treatment
Subjects prescribed zanamivir
Subjects prescribed zanamivir during study period
Drug: Zanamivir hydrate



Primary Outcome Measures :
  1. The number of incidence of adverse events in subjects treated with zanamivir [ Time Frame: 11 days ]
  2. Occurrence of influenza virus infection [ Time Frame: 11 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

<Zanamivir prophylactic administration group> Subjects meeting all of the following criteria and starting prophylactic administration of zanamivir

  • family or persons living with patients with influenza virus infection
  • subjects meeting any of the following criteria, elderly subjects ( 65 years old and over), subjects with chronic cardiac disease, with metabolic disease (diabetes, etc.) or with renal dysfunction
  • unvaccinated persons during the applicable seasons
  • subjects whose consent to write influenza diary was obtained

<Non-zanamivir prophylactic administration group>

- subjects meeting all of the above criteria and NOT starting prophylactic administration of zanamivir

Criteria

Inclusion Criteria:

  • Subjects who meet the study population criteria

Exclusion Criteria:

  • Subjects with a history of hypersensitivity to the ingredients of zanamivir

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01390792


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

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.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01390792     History of Changes
Other Study ID Numbers: 112316
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Zanamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action