Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01479491
Other study ID # 116259
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Recruiting NCT02052063 - Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ? N/A
Completed NCT03185637 - Children's Surgery in Sub-Saharan Africa N/A
Completed NCT00256984 - Study of Stapled Transanal Rectal Resection (STARR) Surgery in Refractory Constipation Associated With Obstructive Defecation Syndrome (ODS) Phase 4
Completed NCT02542462 - Potential Mechanisms for Intussusception After Rotavirus Vaccine-Pilot Study Phase 4
Completed NCT03360643 - Point-of-Care Ultrasonography for Intussusception N/A
Completed NCT01177839 - Study to Assess the Incidence of Intussusception in Children < 2 Years of Age in Singapore N/A
Completed NCT04020939 - The Role of Indocyanine Green Angiography Fluorescence on Intestinal Resections in Pediatric Surgery. N/A
Recruiting NCT04829032 - GOODBYE HARTMANN TRIAL: 100 YEARS OF HARTMANN'S PROCEDURE
Completed NCT05259670 - Risk Factors for Recurrent Intussusception Successful Reduction in Pediatric Patients
Not yet recruiting NCT04454320 - Seasonal Variations and Different Treatment Protocols of Intussusception in Children: Our Centers Experiences
Recruiting NCT05710913 - Development of Machine Learning Models for the Prediction of BMI and Complications After Bariatric Surgery (CABS-Study)
Completed NCT06351163 - Minimally Invasive Surgical Management for Pediatric Intussusception: A Retrospective Cohort Study
Completed NCT06365333 - Pneumatic Reduction For Intussusception In Children: A Retrospective Cohort Study
Completed NCT00673400 - Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM N/A
Completed NCT04486300 - Seasonal Variations and Different Treatment Protocols OF Intussusception In Children: N/A
Completed NCT00556283 - RCT: STARR vs Biofeedback Phase 4
Recruiting NCT05640375 - Follow-up and Steroid Treatment Results in Intussusception Phase 1/Phase 2
Recruiting NCT02691858 - Effect of Hydrocortisone on Improving Outcome of Pneumatic Reduction of Infantile Intussusception N/A
Completed NCT00436358 - Implementing Hospital-based Active Surveillance Procedures for Vaccine Safety Monitoring at IMSS Hospitals in Mexico N/A