Relenza® Sentinel Site Monitoring Program in Japan - Full Text View

Purpose

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.

Condition	Intervention
Influenza, Human	Drug: zanamivir

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Collection of Patients' Background InformationRelenza® Sentinel Site Monitoring Program in Japan

Resource links provided by NLM:

MedlinePlus related topics: Flu

Drug Information available for: Zanamivir

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Number of Participants With Any Adverse Drug Reaction [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
An adverse drug reaction is defined as a drug adverse event that a physician has determined to be related to the use of Relenza. A drug adverse event is defined as any unfavorable or unintended sign (including laboratory test abnormalities), symptom, or disease that occurs when a drug is administered, regardless of the relationship to the drug. For a complete list of all adverse drug reactions recorded during the study, see the section entitled "Other (Non-serious) Adverse Events."

Secondary Outcome Measures:

Number of Participants With Any Serious Adverse Drug Reaction (ADR) [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
A serious ADR is defined as a serious adverse drug event (ADE) that a physician has determined to be related to the use of Relenza. Serious ADE: death caused by an ADR; an event that is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, results in severe symptoms requiring treatment so that symptoms do not lead to previously mentioned outcomes, and a congenital anomaly/birth defect. For a complete list of all serious ADRs recorded during the study, see "Serious Adverse Events" section.
Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Number of Participants in the Indicated Age Categories With Either a Serious or Non-serious Adverse Drug Reaction [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Reason for the Use of Relenza [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
The dose given for treatment of influenza is 10 mg twice daily for 5days. Prophylaxis is defined as a measure taken for the prevention of a disease or condition. The prophylactic dose of Relenza is 10 mg once daily for 10 days.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Categorized by Either Having Complications or Having no Complications [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
A complication is defined as asthma.
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 [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Risk factors are defined as pregnancy; infancy; being elderly; and having chronic respiratory disease, cardiocirculatory disease, and/or diabetes.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also in the Indicated High-risk Categories [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Participants with only hypertension were excluded from the cardiocirculatory disease category. Participants in high-risk categories are at risk for the aggravation of both infection and symptoms.
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Vaccinated for Influenza [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Number of Participants With Either a Serious or Non-serious Adverse Drug Reaction Who Were Also Taking Concomitant Medications [ Time Frame: 5 months (November 2009 to March 2010) ] [ Designated as safety issue: No ]
Concomitant medications are defined as drugs used during the administration of Relenza.

Enrollment:	1575
Study Start Date:	November 2009
Study Completion Date:	April 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Influenza virus infection patients exposed to zanamivir Safety of Influenza virus infection patients exposed to zanamivir	Drug: zanamivir zanamivir

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

1600 cases (of which 90 shall be pregnant women)

Criteria

Inclusion Criteria:

Prescribed Relenza® for the purpose of either treatment or prophylaxis of influenza

Exclusion Criteria:

N/A

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01199744

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01199744 History of Changes
Other Study ID Numbers:	114045
Study First Received:	September 9, 2010
Results First Received:	March 17, 2011
Last Updated:	November 17, 2011
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Influenza
Relenza®
SSMP

Additional relevant MeSH terms:

Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Zanamivir

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

Relenza® Sentinel Site Monitoring Program in Japan (SSMP)