Study on the Incidence of Intussusception (IS) in Children Aged < 12 Months in Japan

Intussusception Clinical Trial

Official title:

Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01479491
• Other study ID #: 116259
• Status: Completed
• Phase: N/A
• First received: November 22, 2011
• Last updated: October 18, 2012
• Start date: November 2011
• Est. completion date: November 2011

Study information

• Verified date: October 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial Summary

This study aims to analyse baseline data on IS in order to monitor the possibility of increased risk of IS in children aged <12 months after introduction of the Rotarix vaccination in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

Inclusion Criteria:

• A male or female infant aged < 12 months at the time of IS diagnosis and affiliated to the JMDC-MDB database.

• An IS case should be identified as per the ICD-10 diagnostic code-K56.1 (any-field listed), examination codes, and procedural codes.

Exclusion Criteria:

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Intussusception

Intervention

Other:
• Data collection
Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of IS in subjects aged < 12 months		Between January 2005 and April 2011 (6 years)	No
Primary	Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan		Between January 2005 and April 2011 (6 years)	No
Secondary	Number of IS cases hospitalized more than once among subjects aged < 12 months.		Between January 2005 and April 2011 (6 years)	No
Secondary	Occurrence of IS cases by calendar months and year among subjects aged < 12 months		Between January 2005 and April 2011 (6 years)	No