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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01479491
First received: November 22, 2011
Last updated: October 18, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Intussusception
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Observational Database Study on the Incidence of Intussusception in Children Aged < 12 Months in Japan

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of IS in subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ] [ Designated as safety issue: No ]
  • Occurrence of age-specific and gender-specific incidence of IS among subjects aged < 12 months in Japan [ Time Frame: Between January 2005 and April 2011 (6 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of IS cases hospitalized more than once among subjects aged < 12 months. [ Time Frame: Between January 2005 and April 2011 (6 years) ] [ Designated as safety issue: No ]
  • Occurrence of IS cases by calendar months and year among subjects aged < 12 months [ Time Frame: Between January 2005 and April 2011 (6 years) ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: November 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Case Group
Children aged < 12 months presenting with IS and covered by the Japan Medical Data Centre Company Limited (JMDC), Tokyo referred to as the JMDC Medical Data Bank (JMDC-MDB).
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.

  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children aged <12 months presenting with IS and covered by the JMDC-MDB database from January 2005 to April 2011.

Criteria

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:

Not applicable

  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: NCT01479491

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01479491     History of Changes
Other Study ID Numbers: 116259
Study First Received: November 22, 2011
Last Updated: October 18, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Japan
Retrospective
Observational
Epidemiological study
Children aged < 12 months
Intussusception

Additional relevant MeSH terms:
Intussusception
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014