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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01390792
First received: July 7, 2011
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

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 Intervention
Influenza, Human
Drug: Zanamivir hydrate

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Relenza® (Zanamivir) (Prophylaxis)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of incidence of adverse events in subjects treated with zanamivir [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • Occurrence of influenza virus infection [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Enrollment: 622
Study Start Date: January 2007
Study Completion Date: May 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed zanamivir
Subjects prescribed zanamivir during study period
Drug: Zanamivir hydrate

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01390792

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

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: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01390792     History of Changes
Other Study ID Numbers: 112316
Study First Received: July 7, 2011
Last Updated: July 14, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on October 29, 2014