Relenza® Sentinel Site Monitoring Program in Japan

NCT01199744 | Completed Results

• 1 other identifier: 114045
• Study Type: observational
• Target: 1,575
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Influenza, Human

Keywords

Influenza; Relenza®; SSMP

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Any Adverse Drug Reaction

  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."

  5 months (November 2009 to March 2010)

Secondary Outcomes (9)

• Number of Participants With Any Serious Adverse Drug Reaction (ADR)

  5 months (November 2009 to March 2010)

• Number of Male and Female Participants With Either a Serious or Non-serious Adverse Drug Reaction

  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

  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

  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

  5 months (November 2009 to March 2010)

Study Arms (1)

Influenza virus infection patients exposed to zanamivir

Safety of Influenza virus infection patients exposed to zanamivir

Drug: zanamivir

Interventions

zanamivir DRUG

zanamivir

Influenza virus infection patients exposed to zanamivir

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

1600 cases (of which 90 shall be pregnant women)

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• GlaxoSmithKline: lead

Related Publications (1)

• Medicine and Drug Journal Vol.46 No.12 p.136-142, 2010

  BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Interventions

Zanamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Sialic Acids; Neuraminic Acids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Amino Sugars; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2010
• First Posted: September 13, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: July 6, 2017
• Results First Posted: April 12, 2011

Record last verified: 2017-06