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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01177839
Other study ID # 999910/193
Secondary ID
Status Completed
Phase N/A
First received August 6, 2010
Last updated November 21, 2012
Start date May 2002
Est. completion date July 2010

Study information

Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Singapore: Health Sciences Authority
Study type Observational

Clinical Trial Summary

This prospective study aims to estimate the incidence of intussusception among children < 2 years old through hospital-based surveillance in Singapore.


Recruitment information / eligibility

Status Completed
Enrollment 178
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Months
Eligibility Inclusion Criteria:

- A male or female infant aged < 24months at the time of diagnosis of intussusception.

- Subject is diagnosed with definite, probable, possible, suspected intussusception during the period of at least one year beginning at study start.

- Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

- A male or female infant = 24 months of age at the time of intussusception diagnosis.

- The subject has had a radiographically or surgically confirmed case of intussusception prior to the current episode.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
Screening sheets
Reviewing screening sheets

Locations

Country Name City State
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore
Singapore GSK Investigational Site Singapore

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Singapore, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of definite, probable and possible IS cases in children < 5 yrs of age Average timeframe: one year No
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